Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up.

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Oliveira, Rui; Botelho, Francisco; Silva, Pedro; Resende, Alexandre; Silva, Carlos; Dinis, Paulo; Cruz, Francisco

2011-06-01

Contemporary surgical treatment of female stress urinary incontinence (SUI) includes retropubic and transobturator (TO) midurethral slings (MUS). Case series of single-incision slings (SIS) have shown similar outcomes with lower morbidity. Our aim was to assess the cure rates, complications, and quality-of-life impact of one standard TO MUS and two SIS. Ninety consecutive patients with clinically and urodynamically proven SUI were enrolled in an exploratory randomised phase 2 trial. Patients with previous SUI surgery, major pelvic organ prolapse, mixed incontinence, or detrusor overactivity were excluded. Patients were treated randomly with TVT-O, TVT-Secur, or Mini-Arc. Postoperative visits were scheduled at 6 and 12 mo. The King's Health Questionnaire (KHQ) was repeated at 6 mo. Cure was defined as the absence of urine leakage, no pad use, and a negative cough test at 12 mo. Pain and other complications were also investigated. Cure rate was 83% after TVT-O, 67% after TVT-Secur, and 87% after Mini-Arc. Improvement was found in 10%, 13%, and 7% of the patients, respectively. Failures were 7% after TVT-O and Mini-Arc and 20% after TVT-Secur. TVT-O and Mini-Arc improved at least 15 points in >80% of the patients in six KHQ domains, whereas TVT-Secur could only achieve improvement in three of the nine domains. The pain score was lower in the Mini-Arc group. Complications were more numerous after TVT-O. This study has the limitations inherent in a phase 2 trial with a follow-up limited to 12 mo. Mini-Arc offers cure and improvement rates similar to TVT-O, whereas TVT-Secur may yield an inferior outcome. These findings recommend the urgent launch of large randomised phase 3 studies comparing conventional MUS with SIS, with Mini-Arc the advised option. Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.

TVT versus TVT-O for minimally invasive surgical correction of stress urinary incontinence

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Sola, Vicente; Pardo, Jack; Ricci, Paolo; Guiloff, Enrique; Chiang, Humberto

2007-01-01

OBJECTIVE: The present work describes our experience in surgical correction of stress urinary incontinence, comparing both the TVT and the TVT-O techniques. METHOD: Between October 2001 and March 2004, 76 patients underwent the TVT procedure. Between January 2004 and January 2005, 98 surgical corrections of urinary incontinence were carried out using the TVT-O technique. RESULTS: Median operative time was 28 minutes for TVT and 7 minutes for TVT-O. Intraoperative complications for TVT occurre...

TVT versus TVT-O for minimally invasive surgical correction of stress urinary incontinence

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Vicente Sola

2007-04-01

Full Text Available OBJECTIVE: The present work describes our experience in surgical correction of stress urinary incontinence, comparing both the TVT and the TVT-O techniques. METHOD: Between October 2001 and March 2004, 76 patients underwent the TVT procedure. Between January 2004 and January 2005, 98 surgical corrections of urinary incontinence were carried out using the TVT-O technique. RESULTS: Median operative time was 28 minutes for TVT and 7 minutes for TVT-O. Intraoperative complications for TVT occurred in 4 patients (6.6%: urinary bladder perforation in 3 patients (5%, p = 0.0228 and parietal peritoneum perforation in 1 case (1.6%. No intraoperative complications took place during TVT-O. Immediate postoperative complications: transient urinary retention in TVT, 2 cases (2.6% and overcorrection in TVT-O (1% which was readjusted within 24 hours. There were no late complications after TVT. There were 2 cases (2.04% with late complications in TVT-O. TVT and TVT-O resulted in correction of incontinence in 100% of the patients. CONCLUSION: TVT and TVT-O are two effective techniques for the correction of stress urinary incontinence. TVT-O would seem to be a technique much easier to perform resulting in less intraoperative complications.

Contasure-Needleless compared with transobturator-TVT for the treatment of stress urinary incontinence.

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Amat I Tardiu, Lluís; Martínez Franco, Eva; Laïlla Vicens, Josep Maria

2011-07-01

Single-incision devices for the treatment of stress urinary incontinence (SUI) have been introduced in the last few years. We report a comparison between Obturator Tension-free vaginal tape (TVT-O) and Contasure-Needleless (C-NDL). One hundred and fifty-eight women with primary SUI were scheduled to receive TVT-O or C-NDL and follow-up during the first year. Epidemiological information, complications, blood loss, and pain level were recorded. We also analyze stress test and quality of life. Sixty-three (87.5%) C-NDL presented a negative stress test, compared with 54 (90%) of TVT-O (p value 0.015 for non-inferiority test). Sandvik Severity Index was 0 in 75.4% in the C-NDL group and 87.3% in the TVT-O (p TVT-O group. C-NDL provides similar outcomes as TVT-O after 1-year follow-up. It is necessary that long-term data confirm our results.

Contasure-Needleless® single incision sling compared with transobturator TVT-O® for the treatment of stress urinary incontinence: long-term results.

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Martinez Franco, Eva; Amat Tardiu, Lluís

2015-02-01

This study compared transobturator tension-free vaginal tape (TVT-O®) and Contasure-Needleless (C-NDL®) at long-term follow-up . Non-inferiority, prospective, single-centre , quasi-randomised trial started in September 2006 and finished in April 2011 to compare C-NDL® with transobturator vaginal tape (TVT-O®) mesh in the treatment of stress urinary incontinence (SUI) . Epidemiological information, intraoperative and postoperative complications, subjective estimates of blood loss and pain levels were recorded. We also analysed the postoperative stress test, the subjective impression of improvement using the Sandvik Severity Index and the quality of life during follow-up using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) . Two hundred and fifty-seven women with primary SUI were scheduled to receive TVT-O® or C-NDL® and were followed up at least 3 years after the procedure . One hundred and eleven women in the C-NDL® group (84.7%) had a negative stress test, compared with 54 women (88.9%) in the TVT-O® group (p = 0.0065 for the non-inferiority test). The postoperative Sandvik Severity Index was 0 or better than the preoperative score in 90.7% of patients in the C-NDL® group and 95.4% of patients in the TVT-O® group (p = 0.0022). The complication rate was similar in both groups. There were significant differences (p = 0.02) in postoperative pain within the TVT-O® group. The degree of satisfaction was not statistically significant between the two groups. The outcomes for the C-NDL® group were similar to those of the TVT-O® group, adding the concept of "single incision tape" to the tension-free sling option.

Comparison of the classic TVT and TVT-Secur.

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Abduljabbar, H S O; Al-Shamrany, H M A; Al-Basri, S F; Abduljabar, H H; Tawati, D A; Owidhah, S P

2013-01-01

Tension-free vaginal tape (TVT) is a well-established surgical procedure for the treatment of female stress urinary incontinence (SUI) and TVT-Secur was designed to reduce the undesired complications and to minimize the operative procedure as much as possible. To present the authors' experience in using the classic TVT and TVT-Secur and to evaluate and compare complications and short- and long-term results. A retrospective study and analysis of 230 patients presented with SUI at King Abdulaziz University Hospital (KAUH) and United Doctor Hospital (UDH) from March 1, 2007 until July 3, 2010. Classical TVT and TVT-Secur with or without associated operation were performed. All patients were controlled at six months and complications, as well as objective results, have been reported. The study was approved by ethical committee of KAUH. All patients with SUI admitted to KAUH and UDH for sub-urethral tape were analyzed (230 patients); 149 had classical TVT and 81 had TVT-Secur. Their age ranged from 30 years to 73 years with a mean of 49.8 years and std of 9.4. Their parity ranged from two to 15 with a mean of 6.2 and std of 2.4. One hundred eighty patients had SUI and 50 patients had mixed incontinence. The type of anesthesia used was general anesthesia in 69.6% (160) of cases and regional anesthesia in form of epidural or spine in 30.4% (70) of cases. Operative complications revealed a bladder perforation in 3.5% (eight) of cases and 2.2% had bleeding of more than 200 ml, and 53 patients which contribute to 23% had retention and required a catheter for 48 hours or more. After three months, it was observed that erosion of the mesh occurred in three cases. Fourteen cases (7%) continue to have SUI failure rate. The classical TVT and TVT-Secur were found to be very effective, easy, and safe procedures and with excellent results.

Longitudinal trends with improvement in quality of life after TVT, TVT O and Burch colposuspension procedures.

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Drahoradova, Petra; Martan, Alois; Svabik, Kamil; Zvara, Karel; Otava, Martin; Masata, Jaromir

2011-02-01

Comparison of the quality of life (QoL) trends after TVT, TVT O and Burch colposuspension (BCS) procedures and comparison of long-term subjective and objective outcomes. The study included 215 women who underwent a TVT, TVT O or BCS procedure. We monitored QoL after each procedure and the effect of complications on the QoL as assessed by the IQOL questionnaire over a 3-year period. The study was completed by 74.5% of women after TVT, 74.5% after TVT O, and 65.2% after BCS procedure. In the long-term, the QoL improved from 46.9 to 88.7 and remained stable after BCS; after TVT and TVT O, it declined, but only after TVT O was the decline statistically significant compared to BCS. The IQOL for women with post-operative complications has a clear descending tendency. The effect of the complications is highly significant (pTVT O, but not with TVT or BCS. Anti-incontinence operations significantly improve quality of life for women with MI, but compared to the SI group, the quality of life is worse when measured at a longer time interval after the operation. Anti-incontinence operations significantly improve quality of life, and the difference in preoperative status in the long-term follow-up is demonstrable.

TVT-O vs. TVT for the treatment of SUI: a non-inferiority study.

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Yang, Xiang; Jiang, Min; Chen, Xinliang; Tong, Xiaowen; Li, Huaifang; Qiu, Jin; Shao, Lingyun

2012-01-01

This study aimed to prospectively compare, in terms of efficacy and safety, the tension-free vaginal tape (TVT) and the transobturator vaginal tape inside-out (TVT-O) procedure for stress urinary incontinence. A cough stress test was applied to the objective outcomes, while urinary incontinence-specific quality of life questionnaire was applied to the subjective outcomes. A test for non-inferiority was carried out for detecting the success rate between the two groups. The objective success rates were found to be 95.4% (62/65) in the TVT group and 96.4% (108/112) in the TVT-O group. No significant difference was found between these two groups in the success rate by non-inferiority test (P 0.05). In the study, the TVT-O procedure could be defined to be identical to the TVT approach in success rate by non-inferiority test.

Comparison of three mid-urethral tension-free tapes (TVT, TVT-O, and TVT-Secur) in the treatment of female stress urinary incontinence: 1-year follow-up.

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Wang, Yi-jun; Li, Fei-ping; Wang, Qian; Yang, Sen; Cai, Xian-guo; Chen, Ying-he

2011-11-01

The purpose of the study was to evaluate and compare the clinical values of tension-free vaginal tape (TVT), tension-free vaginal tape-transobturator (TVT-O), or tension-free vaginal tape-Secur (TVT-Secur) as treatment for female stress urinary incontinence. The pre-operative and 1-year post-operative follow-up protocols for patients who were treated with serial mid-urethral tension-free tape procedures in two hospitals from October 2008 to December 2009 were prospectively studied. These patients were randomly allocated to TVT, TVT-O, or TVT-Secur. A total of 102 women participated. At the 1-year follow-up, complications were not statistically different across the three groups except for pain in the thigh, which was more common in the TVT-O group. The overall efficacy and cure rate were similar between the TVT and TVT-O groups, but were significantly lower in the TVT-Secur group. A comparison of the three procedures shows that TVT-O is easy to operate and is as safe as TVT-Secur, and it has similar long-term efficacy to TVT, though, as one of the third-generation mid-urethral tension-free tapes, TVT-Secur is still being evaluated. Basing on the outcome of our study, it had rare complications but unsatisfactory efficacy, and we suggest that TVT-Secur is not fit for severe cases. However, observation and comparison of these groups in a larger sample size on a longer term are needed.

Analytic model comparing the cost utility of TVT versus duloxetine in women with urinary stress incontinence.

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Jacklin, Paul; Duckett, Jonathan; Renganathan, Arasee

2010-08-01

The purpose of this study was to assess cost utility of duloxetine versus tension-free vaginal tape (TVT) as a second-line treatment for urinary stress incontinence. A Markov model was used to compare the cost utility based on a 2-year follow-up period. Quality-adjusted life year (QALY) estimation was performed by assuming a disutility rate of 0.05. Under base-case assumptions, although duloxetine was a cheaper option, TVT gave a considerably higher QALY gain. When a longer follow-up period was considered, TVT had an incremental cost-effectiveness ratio (ICER) of pound 7,710 ($12,651) at 10 years. If the QALY gain from cure was 0.09, then the ICER for duloxetine and TVT would both fall within the indicative National Institute for Health and Clinical Excellence willingness to pay threshold at 2 years, but TVT would be the cost-effective option having extended dominance over duloxetine. This model suggests that TVT is a cost-effective treatment for stress incontinence.

Pelvic Floor 3D Ultrasound of Women with a TVT, TVT-O, or TVT-S for Stress Urinary Incontinence at the Three-year Follow-up.

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Rodrigues, Claudinei A; Bianchi-Ferraro, Ana Maria H M; Zucchi, Eliana Viana Monteiro; Sartori, Marair G F; Girão, Manoel J B C; Jarmy-Di Bella, Zsuzsanna I K

2017-09-01

Objective  Using three-dimensional ultrasound (3D-US), we aimed to compare the tape position and the angle formed by the sling arms in different techniques of mid-urethral sling insertion for the surgical treatment of stress urinary incontinence, three years after surgery. In addition, we examined the correlations between the US findings and the clinical late postoperative results. Methods  A prospective cross-sectional cohort study of 170 patients who underwent a sling procedure between May 2009 and December 2011 was performed. The final sample, with US images of sufficient quality, included 26 retropubic slings (tension-free vaginal tape, TVT), 42 transobturator slings (tension-free vaginal tape-obturator, TVT-O), and 37 single-incision slings (tension-free vaginal tape-Secur, TVT-S). The images (at rest, during the Valsalva maneuver, and during pelvic floor contraction) were analyzed offline by 2 different observers blinded against the surgical and urinary continence status. Group comparisons were performed using the Student t -test, the chi-squared and the Kruskal-Wallis tests, and analyses of variance with Tukey multiple comparisons. Results  Differences among the groups were found in the mean angle of the tape arms (TVT = 119.94°, TVT-O = 141.93°, TVT-S = 121.06°; p  TVT = 1.65 cm, TVT-O = 1.93 cm, TVT-S = 1.95 cm; p  = 0.010). The global objective cure rate was of 87.8% (TVT = 88.5%, TVT-O = 90.5%, TVT-S = 83.8%; p  = 0.701). The overall subjective cure rate was of 83.8% (TVT = 88.5%, TVT-O = 88.5% and TVT-S = 78.4%; p  = 0.514). The slings were located in the mid-urethra in 85.7% of the patients (TVT = 100%, TVT-O = 73.8%, TVT-S = 89.2%; p  = 0.001), with a more distal location associated with obesity (distal: 66.7% obese; mid-urethra: 34% obese; p  = 0.003). Urgency-related symptoms were observed in 23.8% of the patients (TVT = 30.8%, TVT-O = 21.4%, TVT

The TVT-obturator surgical procedure for the treatment of female stress urinary incontinence: a clinical update.

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Waltregny, David; de Leval, Jean

2009-03-01

Six years ago, the inside-out transobturator tape TVT-O procedure was developed for the surgical treatment of female stress urinary incontinence (SUI) with the aim of minimizing the risk of urethra and bladder injuries and ensuring minimal tissue dissection. Initial feasibility and efficacy studies suggested that the TVT-O procedure is associated with high SUI cure rates and low morbidity at short term. A recent analysis of medium-term results indicated that the TVT-O procedure is efficient, with maintenance, after a 3-year minimum follow-up, of cure rates comparing favorably with those reported for TVT. No late complications were observed. As of July 2008, more than 35 clinical papers, including ten randomized trials and two national registries, have been published on the outcome of the TVT-O surgery. Results from these studies have confirmed that the TVT-O procedure is safe and as efficient as the TVT procedure, at least in the short/medium term.

[A comparative study between two procedures of TVT retropubic mid-urethral sling placement for treatment of female stress urinary incontinence].

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Sergent, F; Gay-Crosier, G; Resch, B; Pons, J-C; Marpeau, L

2014-03-01

To evaluate complications and functional outcomes at 1 year and more of a modified Tension-free Vaginal Tape (TVT) technique from that of classic TVT. Retrospective study comparing the two techniques. For the modified TVT technique, a peri-urethrovesical hydrodissection was performed. An 18-gauge hollow needle, in which a thread was introduced, was used as an ancillary for the placement of the sling. The sling was secured to the thread and then positioned with it. Bladder filling objectified perforations. An absorbable suture around the sling allowed its descent if necessary. One hundred and eighteen procedures were performed (54 classic TVT and 64 modified TVT). For the standard TVT and the modified TVT, the vesico-urethral perforation rates were respectively 7.4% and 1.5% (PTVT versus 88.2% and 90% for the modified TVT (NS). The dissatisfaction rate was lower for the modified TVT (PTVT, it is possible to reduce its complications while maintaining its efficacy. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

TVT-taitotasohankkeen arviointi

OpenAIRE

Natunen, Teemu

2012-01-01

Tässä tutkielmassa selvitetään tietotekniikan käyttöä nykypäivän opetuksessa sekä perehdytään TVT-taitotasohankkeeseen. TVT-taitotasohankkeen tarkoitus on määritellä riittävä TVT-taitotaso lukion opiskelijoille ja luoda testi, jolla TVT-taitotasoa mitataan. Tässä tutkielmassa selvitetään, kuinka hanke on onnistunut taitotason määrittämisessä ja TVT-testin luonnissa

[Comparison of quality of life of patients treated for SUI by surgical approaches AJUST and TVT-O - a 3-month results from randomized trial].

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Smažinka, M; Švabík, K; Hubka, P; Haddad El, R; Mašata, J

2015-06-01

The aim of this study is to compare quality of life in 3-month follow-up after the use of transobturator tape TVT-O and single incision tape AJUST in the treatment of urodynamic stress urinary incontinence (USI). Randomized trial. Gynekologicko-porodnická klinika LF UK a FN Plzeň, Gynekologicko-porodnická klinika 1. LF UK a VFN Praha. Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial. These patients were randomly chosen and devided into two group: 50 patients for TVT-O procedure and 50 patients for AJUST procedure. All of the patients underwent a complete urogynecological examination prior to the actual procedure (clinical examination, urodynamic examination, ultrasound examination) and filled in ICIQ-SF and iQol questionnaires. After the surgery, the patients satisfaction was evaluated by visual analoque scale (VAS) and Likert scale and by ICIQ-SF and iQol questionnaires. The intensity and length of postoperative pain was monitored using the visual analogue scale. The patients underwent an examination after 3 months. In both groups of participants no significant differences regarding age, BMI, parity, history of surgery for gynecological disorders, were found. Preoperative urodynamic, ICIQ-SF and iQol parameters were also not significantly different. In the 3-month follow-up 48 participants from TVT-O group and 50 participants from the AJUST group were monitored. No statistically significant differences in subjective and objective parameters were found. Subjectively stress incontinence was not present in 97.9% in the TVT-O and 96.0% in the group AJUST. Objectively stress test was negative in 93.8% in the TVT-O and 94% in group AJUST. By evaluating the ICIQ and iQol were found no statistical differences in the quality of life in both operating groups. At 3-months follow up we did not find any statistical difference between subjective and objective outcome for single incision tape

[Comparative study of the LIFT and the TVT procedure in the surgical treatment of female stress urinary incontinence].

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Boukerrou, M; Just, S Bresson; Girard, J-M; Nayama, M; Cosson, M

2008-02-01

The purpose of the study was to compare a polyester mesh coated with silicone (LIFT, Cousin) to a polypropylene mesh (TVT, Gynecare), in terms of results, and short and middle term complications. We have performed a retrospective study concerning 140 patients between 2000 and 2002 (71 LIFT and 69 TVT operated for stress incontinence with or without vaginal surgery (prolapse surgery or hysterectomy). We noticed per- and postoperative complications. The patients were contacted by phone to evaluate the middle and long-term results. The mean age of the patients were of 58.8+/-11.3 years in LIFT group and 57.2+/-7.5 years in TVT group. More intraoperative complications arose in the TVT group (six bladder injuries and three haemorrhages versus two in LIFT group, pTVT. 80% of the patients were dry in the LIFT and 75.8% in the TVT group. There was no significant difference concerning the rate of de novo urge incontinence (18.3 versus 17.7%) and voiding difficulties (10 versus 16%). On the other hand, 6.7% of the patients of the group LIFT presented bad healing with prosthesis exposure, in every case a partial resection of the mesh was performed. We did not observe any case of exposure in the TVT group. The LIFT seems as effective as the TVT with a rate of de novo urge incontinence and voiding difficulties similar to the TVT and to the literature's data. However the rate of 6.7% of exposure leads us to prefer polypropylene meshes.

Are the same tapes really the same? Ultrasound study of laser-cut and mechanically cut TVT-O post-operative behavior.

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Rusavy, Zdenek; Masata, Jaromir; Svabik, Kamil; Hubka, Petr; Zvara, Karel; Martan, Alois

2017-11-25

TVT-O production has been modified to laser cutting from mechanical cutting. We compared the behavior of laser and mechanically cut tension-free vaginal tape-obturator (TVT-O) using ultrasound at various time points after surgery. This is a retrospective analysis of clinical and ultrasound data from two previously reported randomized controlled trials with TVT-O. Behavior of mechanically cut TVT-O implanted in January 2007 to November 2009 and laser-cut TVT-O implanted in May 2010 to May 2012 was assessed by ultrasound at day 1, the 2nd week, the 3rd month, and the 1st and 2nd years post-operatively. Bladder neck and tape margins positions were described by coordinates in the orthogonal system calculated from polar coordinates. Tape mobility was measured as a change in the upper and lower tape margin position from rest to maximal Valsalva. Comparison of 2-year subjective and objective surgery outcomes was also performed. In total, 68 mechanically cut and 50 laser-cut TVT-Os were implanted. Follow-up data were available from 49 and 45 women respectively. No differences in any baseline characteristics or bladder neck mobility were observed. Significantly lower tape mobility was observed on day 1 and week 2 after mechanically cut TVT-O, although subsequent mobility was comparable to laser-cut TVT-O. The subjective and objective surgery outcomes were comparable. Although without clinical significance, early postoperative behavior of the mechanically cut and laser-cut TVT-O tapes differs. The less stiff, mechanically-cut TVT-O loosens within 2 weeks of implantation, whereas the stiffer, laser-cut TVT-O keeps its tension.

Decreasing transobturator sling groin pain without decreasing efficacy using TVT-Abbrevo.

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Shaw, Jonathan S; Jeppson, Peter C; Rardin, Charles R

2015-09-01

Groin pain following a transobturator (TO) midurethral sling is not uncommon and can be difficult to manage. We sought to determine if decreasing the mesh burden in the groin would decrease pain. The primary objective was to compare the incidence of post-operative groin pain following placement of full-length TVT-Obturator versus the shorter TVT-Abbrevo. Secondarily, we aimed to compare the efficacy between both devices 6 months after surgery. This is a retrospective cohort study of all women who underwent a TO midurethral sling by the division of urogynecology at one institution between 1 January 2007 and 31 October 2013. Charts were reviewed and the incidence of post-operative groin pain in the two groups dichotomized as present or absent and compared using a Chi-squared test. Validated questionnaire scores of the groups were compared using t tests. There were 125 patients who received a TVT-Obturator and 100 patients who received a TVT-Abbrevo. No differences in demographic data were present between the groups. Twelve patients (9.6 %) in the TVT-Obturator group and 1 patient (1 %) in the TVT-Abbrevo group experienced bothersome groin pain (P value = 0.007). The complete pre- and 6-month post-operative ISI, UDI-6 and PFIQ-7 scores were available for 76 (61 %), 47 (38 %), and 45 (36 %) patients following TVT-Obturator and 57 (57 %), 30 (30 %), and 28 (28 %) following TVT-Abbrevo treatment. At 6 months the mean improvement in questionnaire scores for the TVT-Obturator and TVT-Abbrevo groups were as follows: 5.0 and 5.1 for ISI (P value = 0.9), 8.3 and 7.9 for UDI-6 (P value = 0.8), and 4.8 and 6.1 for PFIQ-7 (P value = 0.4). Use of TVT-Abbrevo reduces post-operative groin pain compared with the full-length TVT-Obturator, without any reduction in efficacy.

TVT versus TOT, 2-year prospective randomized study.

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Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

2013-06-01

To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

Comparison of TVT and TVT-O in patients with stress urinary incontinence: short-term cure rates and factors influencing the outcome. A prospective randomised study.

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Karateke, Ates; Haliloglu, Berna; Cam, Cetin; Sakalli, Mustafa

2009-02-01

Recently, mid-urethral slings have been commonly used in treatment of patients with stress urinary incontinence (SUI). To investigate tension-free vaginal tape (TVT) and tension-free obturator tape (TVT-O) for surgical treatment of SUI for cure rates (primary endpoint), complications and factors influencing cure rate (secondary endpoints). One-hundred and sixty-four patients were included in the study (n = 81 for TVT, n = 83 for TVT-O). The cure rates, complications, preoperative and postoperative urodynamic evaluation, Q-tip test, the Turkish version of Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) scores were recorded. At three and 12 months, the patients were evaluated regarding outcome measures. The cure rates were similar in TVT and TVT-O groups, 88.9% versus 86.7% respectively. Mean operative time was significantly shorter in TVT-O group (P = 0.001). The cure rate was significantly higher in both groups in patients with urethral hypermobility when compared with those with no hypermobility (P = 0.001). The TVT and TVT-O procedures appear to be equally effective for the treatment of SUI. Also, urethral hypermobility seems to be a factor influencing cure rate of mid-urethral slings.

The Efficiency and Safety of Tension-Free Vaginal Tape (TVT) Abbrevo Procedure Versus TVT Exact in the Normal Weight and Overweight Patients Affected by Stress Urinary Incontinence.

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Sun, Yi; Luo, Deyi; Yang, Lu; Wei, Xin; Tang, Cai; Chen, Mei; Shen, Hong; Wei, Qiang

2017-12-01

To compare the efficacy between 2 different slings in normal weight and overweight women. Of 426 women, 220 (119 normal weight and 101 overweight) accepted the tension-free vaginal tape Abbrevo (TVT-A) and 206 (114 normal weight and 92 overweight) accepted the TVT Exact (TVT-E) procedure. Data collected contained the subjective efficiency, objective efficiency International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Incontinence Quality of Life Questionnaire (I-QOL), Pelvic Floor Impact Questionnaire-Short Form (PFIQ-7), Urogenital Distress Inventory-Short Form (UDI-6), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-Short Form (PISQ)-12 at 36 months after surgery. In the normal weight patients, the subjectively and objectively cured rates were all high in both TVT-A and TVE-E (94.12% and 95.61% in objective result; 92.44% and 94.74% in subjective result). In addition, the score of I-QOL, PFIQ-7, and UDI-6 have significantly changed (P TVT-E than TVT-A. Moreover, the score of I-QOL, PFIQ-7, and UDI-6 of overweight women have significantly changed only in the TVT-E (P TVT-A and TVT-E, respectively). The TVT-E might be a better choice for the overweight patient than TVT-A. Copyright © 2017 Elsevier Inc. All rights reserved.

Bladder injury and success rates following retropubic mid-urethral sling: TVT EXACT™ vs. TVT™.

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Thubert, Thibault; Canel, Virginie; Vinchant, Marie; Wigniolle, Ingrid; Fernandez, Hervé; Deffieux, Xavier

2016-03-01

Although placement of a retropubic mid-urethral slings (MUS) is one of the gold standard surgical treatments for stress urinary incontinence, new devices are poorly evaluated before marketing. We compared TVT-EXACT™ (TVT-E), a new device expected to reduce bladder injuries, with the historically described bottom-to-top TVT™ (TVT). This retrospective study compared TVT-E (n=49) and TVT (n=49). The main outcomes were the prevalence of complications (bladder injuries, immediate postoperative pain, perioperative complications, etc.) and the short-term success rate (no reported urinary leakage and negative cough test) of both MUSs. Minimum follow-up was 12 months. The characteristics of the two groups were comparable. The prevalence of bladder injury for TVT-E and TVT was 8% and 6%, respectively (p=1). The intensity of immediate postoperative pain (VAS/100) was lower following TVT-E than after TVT (8.0 vs. 15.9, p=0.01). The first post-void residual was increased in the TVT-E group (153.9 vs. 78.9mL, p=0.045), and there were more postoperative bladder outlet obstruction (BOO) symptoms in the TVT-E group (24% vs. 6%, p=0.02). However, there was no difference when considering only de novo BOO (14% vs. 4%, p=0.16). The prevalence of peri- and post-operative complications was equal in the two groups. The success rate was similar at 12 months of follow-up (80 vs. 82%, p=1). The prevalence of bladder injury was unchanged with TVT-EXACT™ compared with TVT™, but post-operative pain was decreased. The success rate of both retropubic MUSs was similar at 12 months of follow-up. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Tension free vaginal tape (TVT) vs Transobturator tape (TOT) complications and outcomes.

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Potić, Milan; Ignjatović, Ivan; Bašić, Dragoslav

2014-01-01

Stress urinary incontinence (SUI) is managed with both TVT and TOT. The TVT route of placement could result in a higher com-plication rate. The aim of this study is to analyze and compare outcomes and complications of TVT and TOT in SUI treatment. Prospective study in 64 women with isolated SUI was validated through Urogenital Distress Inventory (UDI-6), Incontinence Impact questionnaire (IIQ-7) and International Continence Impact Questionnaire (ICIQ5-SF). Intraoperative and postoperative complications were noted. Patients were considered cured when negative on stress test and with no need for additional surgery during follow up, after one and three months. The cure rates for both TVT 26/30 (86,6%) and TOT 30/34 (88,2) were comparable. Higher rates of bleeding, bladder perforations, pain and dyspareunia are recorded in TVT group. Quality of life graded on the questionnaire basis proved significant improvement in both procedures. Both TVT and TOT have comparable cure results in the treatment of SUI. The TOT is equally effective in the SUI treatment with significantly lower complication incidence.

Millaisia TVT-taitoja on valmistuvilla aineenopettajilla

OpenAIRE

Kolu, Mika

2012-01-01

Tässä pro gradu -tutkielmassa tutkitaan, millaisia TVT-taitoja on Jyväskylän yliopistosta valmistuvilla aineenopettajilla. Lisäksi selvitetään millainen merkitys TVT:lla on yhteiskunnassa ja opetuskäytössä yleisesti. Toisessa luvussa kerrotaan miten Opetushallitus ja -ministeriö on määritellyt TVT:n tavoitetilan yhteiskunnassa, ja sen hyödyntämisen opetuksessa. Samalla käydään läpi eri kuntien käytänteitä TVT:n käyttöönotossa. Kolmannessa luvussa selvitetään millaisia opettajien TVT-taitoja o...

Dynamic MRI confirms support of the mid-urethra by TVT and TVT-O surgery for stress incontinence.

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Rinne, Kirsi; Kainulainen, Sakari; Aukee, Sinikka; Heinonen, Seppo; Nilsson, Carl G

2011-06-01

To study changes in mid-urethral function with dynamic MRI in stress urinary incontinent women undergoing either tension-free vaginal tape (TVT) or TVT-obturator sling operations. Prospective clinical study. University hospital. Forty-two parous women with stress urinary incontinence recruited to dynamic magnetic resonance imaging before and after mid-urethral sling surgery. Control group of 16 healthy women. Dynamic magnetic resonance imaging at rest, during pelvic floor muscle contraction, coughing and voiding with a bladder volume of 200-300 ml. X- and Y- coordinates were used to determine the location of the mid-urethra during these activities. Changes in mid-urethral position after TVT and TVT-obturator operations during the different activities. Postoperatively the women could elevate their mid-urethra by pelvic floor muscle contraction significantly higher than before the operation (pTVT and the TVT-O mid-urethral slings, we could not see any differences in the movement patterns. Mid-urethral slings support the mid-urethra and restrict downward movement during different activities. Movement patterns are similar after TVT and TVT-O operations. © 2011 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2011 Nordic Federation of Societies of Obstetrics and Gynecology.

TVT-Secur mini-sling for stress urinary incontinence: a review of outcomes at 12 months.

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Walsh, Colin A

2011-09-01

• Synthetic mid-urethral slings (MUSs) are considered the first choice surgical procedure for stress urinary incontinence. Recent publications have raised concerns about the efficacy of third generation single-incision mini-slings. The present paper is a systematic review of studies reporting 12-month outcomes after the TVT-Secur (TVT-S) procedure. • Pubmed/Medline online databases, abstracts from recent International Continence Society and International Urogynecological Association annual scientific meetings and the Clinicaltrials.gov and Controlled-trials.com online trial registries were searched for English-language articles containing the terms 'TVT-Secur', 'TVT Secur' or 'mini-sling'. The primary outcomes were objective and subjective cure rates at 12 months. Secondary outcomes included peri-operative (vaginal perforation, urinary retention, urinary tract infection [UTI]) and postoperative (mesh exposure, de novo overactive bladder (OAB), dyspareunia and return to theatre) complication rates. • Among 1178 women undergoing the TVT-S procedure, from 10 studies, both objective and subjective cure rate at 12 months was 76%, with objective cure significantly higher in women undergoing the 'U-type' approach. Vaginal perforation was a complication in 1.5% of cases, with a 2.4% incidence of mesh exposure in the first year. The incidence of de novo OAB symptoms was 10%. Rates of urinary retention (2.3%), UTI (4.4%), dyspareunia (1%) and return to theatre for complications (0.8%) were low. In the first year after a TVT-S procedure 5% of women required repeat continence surgery. • Longer-term studies and randomized comparisons with more established MUSs are required before TVT-S should be routinely used in the surgical treatment of stress urinary incontinence. © 2011 THE AUTHOR. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT versus tension-free vaginal tape (TVT five years after a randomized surgical trial

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Eliasziw Misha

2011-07-01

Full Text Available Abstract Background We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT versus the trans-obturator tape (TOT procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial. Methods/Design All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7. Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature. Discussion This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes

Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial

Science.gov (United States)

2011-01-01

Background We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial. Methods/Design All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature. Discussion This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is

Comparison of TOT and TVT in Treatment of Female Stress Urinary Incontinence

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Taylan Mit

2014-03-01

Full Text Available Aim: To compare the continence results and complications of the tension-free vaginal tape (TVT and transobturator tape (TOT procedures. Material and Method: Sixty two urinary incontinence patients; (37 were stress urinary incontinence and 25 were mixed incontinence underwent TVT or TOT. The clinic-pathologic parameters of the patients, perioperative and postoperative complications and outcome in terms of continence and quality of life were compared. Results: TOT and TVT were performed on % 50 of the patients respectively. An objective cure rate in patients who underwent TOT was observed in 74% of cases, an objective improvement in 26% of cases. 11 of the patients had dysuria, 10 of them had suprapubic pain. An objective cure rate in patients who underwent TVT was observed in 90% of cases, an objective improvement in 8% of cases. A de novo urge incontinence presented in 2 patients. The quality of life improved in 93,5% of cases. In terms of continence results and quality of life, there was no significant difference between the procedures. The complication rate was higher with the TVT procedure when compared to that of the TOT procedure. Discussion: TOT procedure in short terms, performs similar operational success with the TVT procedure. Operational time; in consideration of the cystoscopy time, can be an advantage compared to the TVT procedure. If the operation includes anterior colporrhaphy, the success of both procedures reduces.

Comparing the Transvaginal Tape (TVT and Transobturator Tape (TOT in Stress Urinary Incontinance, for their Efficiency and their Effects on Quality of Life.

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Mahir Mehdiyev

2010-06-01

Full Text Available Objective: To compare the success rates, complications and the effects on the life quality of TOT and TVT operation. Methods: 32 patients who were diagnosed as stress urinary incontinance between March 2005 and november 2006 were included in the study. All patients filled urinar diary and underwent uradinamical exemination after negative urine culture. To evaluate the quality of life I-QoL questionnaire was used. The patients were randomised for TOT and TVT operations. Results: 17 patients underwent TOT operation while 15 patients underwent TVT operations. The mean operation time of TOT group (13.5 min was significantly shorter than TVT groups (18.3 min. There were no intraoperative complications in TOT group whereas there were one bladder injury and one rigt inguinal side subcutaneous hematoma. In early postoperative period there were no complication was seen in TOT group but there were 3 globe vesicale cases were seen in TVT group. there were no differences about blood loss between two groups. the mean hospitalisation time was 2 days in bout two groups (except complicated cases. 1.5 months after the operation all patients were evaluated wiyh cough stress test, residuel urine volume, subjective complains and I-QoL questionneir, no differences were detected between two groups. One patient in TOT group and three patients in TVT group was complicated with de-novo urge incontinance. In our study the objective success rates are 82.3% and 86.7% in TOT and TVT groups respectively. Conclusions: In our study we found that the success rates of TOT and TVT operations were similar and complication rates of TOT was less than TVT group. Further studies that include wide patient populations and has log term follow-up, are needed to get more objective results.

TVT-Exact and midurethral sling (SLING-IUFT) operative procedures: a randomized study.

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Aniuliene, Rosita; Aniulis, Povilas; Skaudickas, Darijus

2015-01-01

The aim of the study is to compare results, effectiveness and complications of TVT exact and midurethral sling (SLING-IUFT) operations in the treatment of female stress urinary incontinence (SUI). A single center nonblind, randomized study of women with SUI who were randomized to TVT-Exact and SLING-IUFT was performed by one surgeon from April 2009 to April 2011. SUI was diagnosed on coughing and Valsalva test and urodynamics (cystometry and uroflowmetry) were assessed before operation and 1 year after surgery. This was a prospective randomized study. The follow up period was 12 months. 76 patients were operated using the TVT-Exact operation and 78 patients - using the SLING-IUFT operation. There was no statistically significant differences between groups for BMI, parity, menopausal status and prolapsed stage (no patients had cystocele greater than stage II). Mean operative time was significantly shorter in the SLING-IUFT group (19 ± 5.6 min.) compared with the TVT-Exact group (27 ± 7.1 min.). There were statistically significant differences in the effectiveness of both procedures: TVT-Exact - at 94.5% and SLING-IUFT - at 61.2% after one year. Hospital stay was statistically significantly shorter in the SLING-IUFT group (1. 2 ± 0.5 days) compared with the TVT-Exact group (3.5 ± 1.5 days). Statistically significantly fewer complications occurred in the SLING-IUFT group. the TVT-Exact and SLING-IUFT operations are both effective for surgical treatment of female stress urinary incontinence. The SLING-IUFT involved a shorter operation time and lower complications rate., the TVT-Exact procedure had statistically significantly more complications than the SLING-IUFT operation, but a higher effectiveness.

Predictive factors that influence treatment outcomes of innovative single incision sling: comparing TVT-Secur to an established transobturator sling for female stress urinary incontinence.

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Hwang, Eugene; Shin, Ju Hyun; Lim, Jae Sung; Song, Ki Hak; Sul, Chong Koo; Na, Yong Gil

2012-07-01

This study aims to identify independent risk factors for treatment failure of tension-free vaginal tape TVT-Secur (TVT-S) compared to that of the well-established transobturator tape. Of a total of 175 consecutive patients with urodynamically confirmed stress urinary incontinence (SUI) identified between July 2007 and March 2010, 89 patients underwent TVT-S, and 86 underwent TOT. Cure was defined using the Urogenital Distress Inventory as no urinary leakage during physical activity, coughing, or sneezing as reported by patients during a telephone survey. To identify predictors of treatment failure, multivariable logistic regression models were used, and odds ratios (ORs) were calculated using variables identified during univariate analysis. There were more patients with cystocele ≥ grade 2 in the TVT-S group (p = 0.031); otherwise the groups were well matched. After a median follow-up of 32 months (range, 12-44 months), the overall cure rate was 80.6%; it was 70.8% for those treated with TVT-S and 90.7% for those treated with TOT (p = 0.001). In a multivariate model, previous incontinence surgery (OR 27.1, p = 0.005) and a cystocele ≥ grade 2 (OR 3.0, p = 0.020) were independent risk factors influencing the outcome of TVT-S procedures. For the TOT procedures, detrusor overactivity was an independent risk factor in a multivariate model (OR 8.6, p = 0.033). TVT-S could be performed for selected patients, but conventional TOT procedures are still superior to the novel TVT-S device.

Postoperative groin pain and success rates following transobturator midurethral sling placement: TVT ABBREVO® system versus TVT™ obturator system.

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Canel, Virginie; Thubert, Thibault; Wigniolle, Ingrid; Fernandez, Hervé; Deffieux, Xavier

2015-10-01

Placement of a transobturator midurethral sling (MUS) is the standard surgical treatment for stress urinary incontinence. Most recent MUS procedures have been poorly evaluated. We compared the results using a "new" device expected to reduce postoperative pain, the TVT ABBREVO® system (TVT-Abb), with those using the TVT™ obturator system (TVT-O). This was a retrospective study comparing the use of the TVT-Abb (in 50 patients) and the TVT-O (in 50 patients). The main outcomes were the amount of postoperative pain, the success rate (no reported urinary leakage and negative cough test) with both MUS procedures, and the prevalence of complications. The mean follow-up time was 12 months. The preoperative characteristics of the two groups were comparable. There was less postoperative pain (VAS, 0 to 100) in the TVT-Abb group than in the TVT-O group (12.2 vs. 24.4, p TVT-Abb group and the TVT-O group (8 % vs. 12 %, p = 0.74). The prevalences of perioperative and postoperative complications (bladder/urethral injury, haemorrhage) in the two groups were equal. The success rates were similar at 12 months after surgery (88 % vs. 78 %, p = 0.29). The success rates with TVT-Abb and TVT-O were equal at 12 months after surgery, but there was less immediate postoperative pain with TVT-Abb.

Protocol for Physiotherapy OR Tvt Randomised Efficacy Trial (PORTRET: a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence

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Buskens Eric

2009-09-01

Full Text Available Abstract Background Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life and economic (119 million Euro/year spent on incontinence pads in the Netherlands burden. Pelvic floor muscle training (PFMT is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial. Methods/Design A multi-centre randomised controlled trial will be performed for women between 35 - 80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire quality of life instruments. The economical endpoint is short term (1 year incremental cost-effectiveness in terms of costs per additional

Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial.

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Masata, Jaromir; Svabik, Kamil; Zvara, Karel; Hubka, Petr; Toman, Ales; Martan, Alois

2016-10-01

The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up. This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O). The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual

Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women-2-year follow-up

Czech Academy of Sciences Publication Activity Database

Mašata, J.; Švabík, K.; Zvára, Karel; Drahorádová, P.; Haddad El, R.; Hubka, P.; Martan, A.

2012-01-01

Roč. 23, č. 10 (2012), s. 1403-1412 ISSN 0937-3462 Institutional research plan: CEZ:AV0Z10300504 Keywords : Stress urinary incontinence * TVT-O * TVT-S * Surgical complication * Treatment failure Subject RIV: FK - Gynaecology, Childbirth Impact factor: 2.169, year: 2012

Ultrasound assessment of tension-free vaginal tape (TVT).

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Flock, F; Kohorst, F; Kreienberg, R; Reich, A

2011-01-01

To date, no standardization for the visualization of tension-free vaginal tape (TVT) has been established in clinical practice. The aim of this prospective observational study was to evaluate the shape and position of the tape using ultrasound and to compare this data with clinical postoperative results. In a three-year period, 296 patients with clinically and urodynamically proven stress urinary incontinence (SUI) were treated with TVT and received follow-up in our department. An additional 12 patients, who were initially treated in other hospitals and had postoperative problems, were included in this study. Depending on the outcome after 3 months, the patients were divided into groups with and without specific disorders. The TVT was evaluated by introital ultrasound. The position of the tape was established by its location in relation to the urethral length and the distance to the hypoechoic center of the urethra (HCU). A suitable TVT position was determined in patients without any postoperative disorders. The mean value for the TVT position at rest in relation to the urethral length was 61 %. The distance to the HCU was 4.6 ± 1.5 mm. In patients with persistent SUI, the tape was more often located under the inner (3 % vs. 0 %) or outer quarter (29 % vs. 13 %, p = 0.004). In patients with residual volume, the distance to the urethra was significantly lower (2.7 vs. 4.6, p TVT may be regularly investigated using ultrasound. In combination with the clinical outcome, it represents an important method of evaluating the tape and assists in the planning of a future therapeutic course of action in cases of postoperative problems. © Georg Thieme Verlag KG Stuttgart · New York.

TVT-S in the U position--anatomical study.

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Hubka, Petr; Nanka, Ondrej; Martan, Alois; Grim, Milos; Zvarova, Jana; Masata, Jaromir

2011-02-01

The objective is to describe the anatomical position of tension-free vaginal tape Secur (TVT-S) in the U position regarding possible injury and fixation site. We placed TVT-S inserters bilaterally in 13 embalmed and five fresh frozen female bodies. After dissection, we measured distances from the obturator bundle. In embalmed bodies, the mean distance of TVT-S from the obturator bundle was 2.83 cm (standard deviation (SD) 0.87 cm) on the left, 2.92 cm (SD 1.24 cm) on the right. Perforation of the fascia of obturator internus muscle occurred in 38.5%. In fresh frozen bodies, results were fundamentally similar (p > 0.05). There is a risk of injury to the obturator bundle and urinary bladder during TVT-S; however, there is a significant risk of inserting the TVT-S inserter outside the obturator internus muscle (into the lesser pelvis). The position of TVT-S does not change significantly after legs mal-positioning.

Surgeon-tailored polypropylene mesh as a needleless single-incision sling versus TVT-O for the treatment of female stress urinary incontinence: a comparative study.

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ElSheemy, Mohammed S; Fathy, Hesham; Hussein, Hussein A; Hussein, Eman A; Hassan, Sarah Mohamed

2015-06-01

To compare safety and efficacy of surgeon-tailored polypropylene mesh through needleless single-incision technique (STM) versus tension-free vaginal tape-obturator (TVT-O) aiming to decrease cost of treatment of stress urinary incontinence (SUI). This is important in developing countries due to limited healthcare resources. A retrospective cohort study was done at Urology and Gynecology Departments (dual-center), Cairo University, from January 2011 to August 2013. STM was inserted in 72 females, while TVT-O was inserted in 48 females. Females evaluated by cough stress test, stress and urge incontinence quality of life questionnaire (SUIQQ), Q max and abdominal leak point pressure (ALPP) were included. Different factors were compared between both groups using paired t, Wilcoxon's signed rank, McNemar, Chi-square, Fisher's exact, independent t or Mann-Whitney tests. Age, parity, previous surgeries, ALPP, intrinsic sphincter deficiency (ISD), associated prolapse and associated prolapse repair were comparable in both groups. No significant difference was found between both groups in postoperative complications (except groin pain), cure, SUIQQ indices improvement and Q max decline. In total, 65 (90 %) cured, 6 (8 %) improved while failure was detected in one (1 %) patient in STM group, while 42 (87 %) cured, 4 (8 %) improved and failure was detected in two (4 %) patients in TVT-O group. Presence of ISD (p = 0.565), urgency (p = 0.496), UUI (p = 0.531), previous surgeries (p = 0.345), associated urogenital prolapse (p = 0.218) or associated prolapse repair (p = 0.592) did not lead to any significant difference in outcome between both groups. Cost of mesh decreased from US$500 (TVT-O) to US$10 (STM). Outcome of STM is comparable to TVT-O. Furthermore, STM is more economic.

Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: 1-year follow-up.

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Tommaselli, Giovanni A; Di Carlo, Costantino; Gargano, Virginia; Formisano, Carmen; Scala, Mariamaddalena; Nappi, Carmine

2010-10-01

To reduce complications of transobturator tension-free vaginal tape, single-incision devices were introduced in the last years. We here report a comparison between the tension-free vaginal tape-obturator (TVT-O) and the TVT-Secur techniques in terms of efficacy and safety. Eighty-four patients with stress urinary incontinence (SUI) were scheduled to undergo TVT-O or TVT-Secur. Duration of the procedure, subjective estimate of blood loss, intraoperative and postoperative complications, postoperative postvoidal residue (PVR), time to first voiding, and pain level were recorded. Urodynamic tests, PVR, Incontinence Questionnaire Short Form (ICIQ-SF), King's Health Questionnaire, and a urinary diary were performed before and 12 months after procedure. No differences in terms of cure rate were observed between the two groups (81.6% vs. 83.8%). Complication rate in the TVT-Secur group was lower (8.1%) than in the TVT-O group (15.8%), but not significant. Both techniques seem to be effective and safe, with a low incidence of complications in both groups.

New surgical technique for treatment of stress urinary incontinence TVT-ABBREVO from development to clinical experience.

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Waltregny, David; de Leval, Jean

2012-12-01

Tension-free suburethral tapes have revolutionized the surgical treatment of female stress urinary incontinence (SUI). These tapes are inserted by way of a retropubic or transobturator route. The inside-out tension-free vaginal tape transobturator approach, or TVT-Obturator system (TVT-O, Ethicon Women's Health and Urology, Somerville, NJ), was developed ten years ago with the aim of minimizing the risk of urinary tract injuries associated with retropubic and outside-in transobturator tapes while reproducibly ensuring minimal tissue dissection. Cadaveric studies have shown that the anatomical trajectory of the TVT-O tape is strictly perineal and courses away from neighboring obturator and pudendal neurovascular structures. Several meta-analyses have shown similar SUI cure rates after retropubic and transobturator tape procedures. Yet, the transobturator route may be associated with less voiding dysfunction, blood loss, bladder perforation, and shorter operating time. The original TVT-O procedure was modified with the aim of reducing the incidence of postoperative groin pain as well as the rather theoretical risk of obturator nerve injury. This modified procedure, named TVT-ABBREVO (Ethicon Women's Health and Urology, Somerville, NJ), utilizes a shortened, 12-cm-long polypropylene tape. In addition, perforation of the obturator membrane with the scissors and guide is avoided in order to reduce the depth of lateral dissection, and consequently, to maximize securing of the tape within the obturator muscular/aponeurotic structures. In a comparative anatomical study, it was indeed observed that the shorter tape traversed less muscular structures (with no or only a minimal amount of tape lying in the adductor muscles) than its original counterpart, while still consistently anchoring in the obturator membrane at a similarly safe distance from the obturator canal. In a single-center randomized clinical trial, after a 3-year minimum follow-up, the modified TVT-O procedure

[Comparison of the efficacy and safety between TVT-O and TVT-O with biofeedback pelvic floor electrical stimulation on female stress urinary incontinence].

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Min, Ling; Zhao, Xia

2015-01-01

To compare the efficacy and safety between tension-free vaginal tape obturator technique (TVT-O) and TVT-O with biofeedback pelvic floor electrical stimulation on the therapy of female stress urinary incontinence. In this prospective study, 120 female patients of female stress urinary incontinence were enrolled from January 2012 to December 2013. The patients were randomly assigned to two groups, 60 in group A received TVT-O alone, while 60 in group B not only received TVT-O but also received biofeedback pelvic floor electrical stimulation. All the patients were followed up for 12 months to assess the efficacy and safety of the two procedures. Subjective indices [total volume of urine (TV), the total frequency of urination (TOV), the total leakage of urine events (TL), urinary incontinence related quality of life questionnaire (I-QOL), International Advisory Committee on urinary incontinence urinary incontinence questionnaire short form scale (ICI-Q-SF)] and objective indices [Valsalva leak point pressure (VLPP), maximum flow rate (MFR), residual urine volume (RUV),pad test] were analyzed. Overall, the cure rate was 75% at 1 year follow-up for group A and 88.33% for group B (PTVT-O on the treatment of female stress urinary incontinence.

Sepsis and multiorgan failure following TVT procedure.

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Stec, Piotr; Connell, Rowan

2014-04-01

Tension-free vaginal tape (TVT), is a commonly performed, low risk procedure for treatment of stress urinary incontinence (SUI). Severe complications are rare, but can be potentially life threatening. We present a case of 66 year old patient who sustained bladder perforation at the time of TVT procedure and subsequently developed sepsis rapidly leading to multi-organ failure and triggering sequence of serious complications. During her inpatient stay she required ITU admission, emergency laparotomy, TVT mesh removal, bowel resection due to ischemic colitis and anticoagulation for pulmonary embolism. Despite of clinical picture of sepsis her microbiology tests were almost consistently negative. This case emphasise importance of awareness and quick recognition of TVT related complications. Patient ultimately survived and recovered thanks to timely and coordinated management by the multidisciplinary team of doctors.

Effect of tension-free vaginal tape and TVT-obturator on lower urinary tract symptoms other than stress urinary incontinence.

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Ballert, Katie N; Kanofsky, Jamie A; Nitti, Victor W

2008-03-01

Variable effects on lower urinary tract symptoms (LUTS) other than stress urinary incontinence (SUI) have been reported after tension-free vaginal tape (TVT). We measured the effect of TVT on LUTS using the American Urological Association Symptom Index (AUASI). Patients undergoing TVT completed the AUASI pre- and post-operatively. Total scores (TS), storage scores (SS), and voiding scores (VS) were compared overall and among patients with SUI vs mixed urinary incontinence (MUI) and those who underwent TVT vs TVT-obturator (TVT-O). The mean change in TS and SS was -3.6 and -3.0. Mean reductions in TS and SS were significant in all patient subsets with no change in VS. There was no significant difference in the mean changes in TS between patients with SUI vs MUI or those undergoing TVT vs TVT-O. LUTS are improved after TVT in most patients. In general, voiding symptoms were not adversely affected.

AB194. A 12-year retrospective evaluation of TVT and TVT-O in the surgical management of SUI in females and the analysis of influence factors

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Zhu, Kejia; Liu, Yaxiao; Chen, Fan; Cheng, Shanshan; Yang, Yue; Shi, Benkang

2016-01-01

Objective We evaluate the clinical effect of TVT and TVT-O slings in the surgical management of SUI in women at mostly 12-year follow-ups and the factors that influence it. Methods In this retrospective analysis, 94 women with stress incontinence treated by TVT (14 cases) or TVT-O (80 cases) were included. Subjective evaluation included ICIQ-SF, KHQ, PGI-I and patient satisfaction, and we recorded the objective data of the procedures. We analyzed whether the age, BMI, disease duration, surgery history, postoperative follow-up duration or other factors were related to the subjective cure rate. Results Eight cases of TVT and 59 cases of TVT-O completed the follow-up. Patients were followed up for 1.3–12 years in TVT and 0.2–9.2 years in TVT-O group. The rates of subjectively assessed success were 87.5% and 84.7%, respectively (P=1.00). The total KHQ were (21.93±30.42) and (16.89±25.85) (P=0.55). The operation duration were (59.29±21.02) in TVT group and (29.87±12.04) in TVT-O group (P=0.00). The postoperative days of indwelling catheter were (4.14±1.79) and (3.11±1.51) (P=0.02), and the post-operation hospitalization days were (5.64±2.06) and (5.01±1.77) (P=0.27). The factors above didn’t affect the subjective cure rate. Conclusions The patient reported long-term success rate were both high and had no significant differences between the groups. Operation duration and postoperative durations of indwelling catheter of TVT-O was shorter. The factors above didn’t affect the subjective cure rate.

Surgeon-tailored polypropylene mesh as a tension-free vaginal tape-obturator versus original TVT-O for the treatment of female stress urinary incontinence: a long-term comparative study.

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ElSheemy, Mohammed S; Fathy, Hesham; Hussein, Hussein A; Elsergany, Ragheb; Hussein, Eman A

2015-10-01

The objective of the study was to compare the safety and efficacy of surgeon-tailored polypropylene mesh (STM) through tension-free vaginal tape-obturator (TVT-O) versus original TVT-O in the treatment of stress urinary incontinence (SUI) aiming to decrease the cost of treatment. This is important in developing countries due to limited health care resources. A retrospective cohort study was done at the Urology and Gynecology Departments (dual-center), Cairo University from May 2007 to June 2010. Women evaluated by cough stress test, Stress and Urge Incontinence and Quality of Life Questionnaire (SUIQQ), maximum flow rate (Qmax), and abdominal leak point pressure (ALPP) with follow-up for at least 48 months were included. Patients with post-void residual urine > 100 ml, bladder capacity TVT-O were inserted in 79 and 66 women, respectively. Intrinsic sphincter deficiency, ALPP, previous surgeries, associated urgency, urgency urinary incontinence (UUI), and prolapse were comparable in both groups. Operative duration was longer in STM by 10 min. No significant difference was found between both groups in complications (p = 0.462), cure (p = 0.654), and different indices of SUIQQ. In STM, 74 (93 %) were cured and 3 (4 %) improved, while SUI persisted in 2 (2 %) patients. In TVT-O, 59 (89 %) were cured and 4 (6 %) improved, while failure was detected in 3 (4 %) patients. The 5-year outcome is comparable between STM and TVT-O. Furthermore, STM is more economical due to our resterilizable modified helical passers and the cheap polypropylene mesh.

Longitudinal trends with Improvement in Quality of Life after TVT, TVT O and Burch Colposuspension Procedures Petra

Czech Academy of Sciences Publication Activity Database

Drahorádová, P.; Martan, A.; Švabík, K.; Zvára, Karel; Otava, M.; Mašata, J.

2011-01-01

Roč. 17, č. 2 (2011), CR67-CR72 ISSN 1234-1010 Institutional research plan: CEZ:AV0Z10300504 Keywords : anti- incontinence surgery * Burch colposuspension * Incontinence Quality of Life * long-term results * Mixed Incontinence * Stress Urinary Incontinence * TVT * TVT O Subject RIV: FK - Gynaecology, Childbirth Impact factor: 1.699, year: 2010 http://www.medscimonit.com/download/index/idArt/881389

Comparing effectiveness of combined transobturator tension-free vaginal mesh (Perigee) and transobturator tension-free vaginal tape (TVT-O) versus anterior colporrhaphy and TVT-O for associated cystocele and urodynamic stress incontinence.

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Lau, Hei-Yu; Twu, Nae-Fang; Chen, Yi-Jen; Horng, Huann-Cheng; Juang, Chi-Mou; Chao, Kuan-Chong

2011-06-01

To evaluate the efficacy and safety of transobturator tension-free vaginal mesh (Perigee) and concomitant transobturator tension-free vaginal tape (TVT-O) for treating cystocele with urodynamic stress incontinence (UDSI). A retrospective study of 115 patients with symptomatic stages 2-3 cystocele and UDSI who were treated with a Perigee system (Group I, n=68) plus TVT-O procedure or traditional anterior colporrhaphy (Group II, n=47) plus TVT-O procedure. All patients were followed up for more than one year. Objective and subjective symptoms were evaluated at one year postoperatively. Statistical analysis was performed using SPSS software. The objective cure rates for cystocele at one year were significantly higher in Group I than in Group II (98.5% and 86.9%, P=0.018), respectively. The cure rates for UDSI in the two groups were 91.0% vs. 91.3% (P=1.000). Symptomatic improvement of frequency was better in Group I than Group II (87.7% vs. 70.0%, P=0.030). There were no significant differences with regard to intraoperative and postoperative complications between the two groups. The combination of the Perigee system and TVT-O offers a safe and effective treatment for cystocele with UDSI and may be performed as first-line treatment. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Perioperative complications and early follow-up with 100 TVT-SECUR procedures.

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Neuman, Menahem

2008-01-01

. This problem was addressed later by making the submucosal dissection deeper to avoid intimate proximity of the tape with the vaginal mucosa. Consequently the tape protrusion rate was reduced to 8% (4 patients). Five (10.0%) patients in the first group had unintended tape removal at the time of inserter removal, necessitating the use of a second TVT-SECUR. This was addressed by meticulous detachment of the inserter before its withdrawal, after which no further unintended tape displacements were recorded. No clinical signs for bowel, bladder, or urethral injuries; intraoperative bleeding; or postoperative infections were evident. Telephone interview at the end of 12 months postoperatively was completed with 44 (88.0%) of the first patient group and 46 (92%) of the second patient group. In all, 39 (88.6%) and 43 (93.5%) of the telephone-interviewed patients of the first and second groups, respectively, reported objective urinary continence. The TVT-SECUR, a new midurethral sling, was associated with early safety and efficacy problems. These were identified and rectified, to make the TVT-SECUR a safe and effective anti-incontinence procedure. Operative complications associated with the TVT, such as bladder penetration and postoperative outlet obstruction, and TVT-obturator complications, such as postoperative thigh pain and bladder outlet obstruction, may be reduced with the TVT-SECUR. The first 100 operations' cumulative data analysis yielded some insights, including the necessity of meticulous and proper dissection before placement of the tape and the need for applying minimal extra tension to the tape. However, long-term comparative data collection will be required to draw solid conclusions regarding the appropriate position of this operative technique within the spectrum of anti-incontinence operations.

[TVT and TOT for surgical correction of female stress urinary incontinence. Comparison between techniques].

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Torres Zambrano, G; Lujan Galán, M; Martín García, C; García Tello, A; Rodríguez García, N; Berenguer Sánchez, A

2008-10-01

Retrospective analysis of a series of patients with stress urinary incontinence that underwent surgery in our department, by means of the TVT and TOT techniques. We evaluate post operative continence, considering "cured" the patient with complete continence and "failure" any type of involuntary stress urine leak, independently of its severity registering the time of its appearance. For this purpose we used the Kaplan-Meier analysis comparing both techniques with the Breslow test. Additionally, postoperative complications were evaluated. 128 patients who underwent surgery by TVT (69 patients, 53.9%) and TOT (59 patients, 46.1%). Mean age was 54.4 years for TVT (95% CI 52.0-56.8) and 59 years for TOT (95% CI 55.9-62.1). Mean follow-up time was 18.7 months for TVT (95% CI 15.6-21.9) and 7.4 months for TOT (95% CI 5.8-8.9). Overall continence rate was 86.7%, 88.4% for TVT and 84.7% for TOT The probability of being continent six months after surgery was 89.1% for TVT and 78.2% for TOT (no significant differences, p = 0.31), with almost all failures within the first six months after surgery. TVT was more frecuently associated with urgency symptoms (33.3%, p = 0.001) and urge incontinence (18.8%,p = 0.16), urinary retention (11.6%, p = 0.38), and prevesical hematoma requiring mesh retrieval. Greater post operative pain was observed with TOT (20.3%, p = 0.005). Our results evidence a similar efficacy with both techniques, with the failures appearing over the first months after surgery. Complications of the voiding urgency type are significantly more frequent with TVT.

Functional and morphological differences following Monarc and TVT-O procedures.

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Huang, W-C; Yang, S-H; Yang, J-M; Tzeng, C-R

2012-12-01

To explore function of the lower urinary tract and morphology of tape and urethra following Monarc or TVT-O suburethral tape placement for urodynamic stress incontinence (USI). We recruited prospectively women undergoing either Monarc or TVT-O placement for USI. Before and 3 months after the procedure, participants were evaluated by a question-directed interview, the measures of Sandvik Incontinence Severity Index (SISI), Incontinence Bother Scale (IBS), Ingelman-Sundberg Score (ISS) and short forms of Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7), physical examination, a cough stress test and 4D ultrasound investigation. The primary outcome was participants' responses to clinical assessments and the secondary outcome was ultrasound findings. A total of 67 women with Monarc procedures and 60 women with TVT-O procedures completed the survey both preoperatively and 3 months postoperatively. There were significant improvements in scores of SISI, IBS, ISS, UDI-6 and IIQ-7 after both Monarc and TVT-O procedures. At the 3-month follow-up, both procedures had similar success rates, SISI scores, IBS scores, ISS scores, UDI-6 scores and IIQ-7 scores, and similar incidences of postoperative voiding difficulty and overactive bladder symptoms. After Bonferroni correction, all ultrasound parameters representing tape location, tape tension and urethral mobility were similar between the two procedures. At short-term follow-up, Monarc and TVT-O procedures are comparable in both functional outcome of the lower urinary tract and morphology on ultrasound as assessed by parameters representing tape location, tape tension and urethral mobility. Copyright © 2012 ISUOG. Published by John Wiley & Sons, Ltd.

The comparison of an inexpensive-modified transobturator vaginal tape versus TVT-O procedure for the surgical treatment of female stress urinary incontinence.

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Zhang, Yan; Jiang, Min; Tong, Xiao-Wen; Fan, Bo-Zhen; Li, Huai-Fang; Chen, Xin-Liang

2011-09-01

To compare the safety and efficacy of an inexpensive-modified transobturator vaginal tape procedure with the transobturator tension-free vaginal tape (TVT-O) procedure for the surgical treatment of female stress urinary incontinence (SUI). Patients with SUI were randomly allocated to either the test group receiving the inexpensive-modified transobturator vaginal tape procedure or the control group receiving the GYNECARE TVT-O procedure. Treatment outcomes and Quality-of-life scores were recorded and analyzed between two groups. A total of 156 patients were enrolled in this trial. Eighty patients underwent the modified transobturator vaginal tape procedure. Among them 75(93.8%) were cured and 5(6.2%) were improved. The rest of the 76 patients underwent the GYNECARE TVT-O procedure with a 92% (70 of 76) cure rate and an 8% (6 of 76) improvement rate. No inefficient or aggravated cases occurred in both groups. The success rates between groups had no significant statistic difference (p > 0.05). The operative time, blood loss, hospital stay, and medical cost were significantly lower in the test group (p < 0.01); the increases in Quality-of-life scores were comparable between groups. The modified transobturator vaginal tape procedure is an efficacious and economic surgical treatment for female SUI. Copyright © 2011. Published by Elsevier B.V.

Modified prepubic TVT-obturator tape procedure versus the conventional method: a preliminary study.

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Long, Cheng-Yu; Wu, Ming-Ping; Wang, Chiu-Lin; Lin, Kun-Ling; Liu, Cheng-Min; Wu, Shu-Hui; Juan, Yung-Shun

2013-12-01

To compare the efficacy and safety of the modified prepubic tension-free vaginal tape-obturator (PTVT-O) system procedure with the original TVT-O methods. One hundred and ninety women with urodynamic stress incontinence (USI) were included in this study (93 cases in the TVT-O group and 97 in the PTVT-O group). Clinical assessments before and one year after surgery included urinalyses, 1-h pad tests, urodynamic studies, and a personal interview with the overactive bladder symptom score (OABSS) questionnaire. There were no differences between the two groups in mean age, parity, menopausal status, mean operative time and subjective cure rates (P>0.05), but the efficacy of surgery (cure and improvement) in the PTVT-O group was significantly higher than that in the TVT-O group (P=0.038). Complication rates and visual analog scale (VAS) scores were found to be similar (P>0.05). OABSS decreased significantly after surgery in both groups (P0.05). Our modified procedure is a safe and effective treatment for female USI. It has an advantage over the original TVT-O with better surgical efficacy and comparable postoperative pain, although the follow-up times in this study are different. Copyright © 2013. Published by Elsevier Ireland Ltd.

Comparison of Efficacy and Satisfaction between the TVT-SECUR® and MONARC® Procedures for the Treatment of Female Stress Urinary Incontinence.

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Jeong, Moo Youl; Kim, Su Jin; Kim, Hyo Sin; Koh, Jun Sung; Kim, Joon Chul

2010-11-01

The tension-free vaginal tape SECUR® (TVT-S) is a new, minimally invasive sling procedure for treating female stress urinary incontinence (SUI). However, results of comparisons of the TVT-S with the transobturator tape (TOT) sling are lacking. Therefore, we investigated outcome and satisfaction of the TVT-S procedure compared with the TOT procedure. We included 64 patients with SUI who underwent the TVT-S (n=31) or TOT (MONARC®, n=33) procedure and were followed up for more than 1 year. The preoperative evaluation included history taking, pelvic examination, consecutive 3-day voiding diary, and urodynamic study including Valsalva leak point pressure. Postoperatively, continence status and subjective patient satisfaction were evaluated. Cure was defined as the absence of any episodes of involuntary urine leakage during stressful activities and a stress cough test. The TVT-S group (71.0%) showed a slightly lower cure rate than did the MONARC group (84.8%); however, there was no significant difference between the 2 groups (p=0.179). Nine of the patients who underwent the TVT-S showed incontinence postoperatively. Among them, the H approach was used in 7 patients and the U approach was done in 2 patients. Following TVT-S and MONARC, the patients' reported satisfaction was 80.6% and 78.8%, respectively. Patient satisfaction did not differ significantly between the two groups (p=0.854). Our results showed that the TVT-S and MONARC procedures may be comparable in terms of cure rate and patient satisfaction after more than 1 year of follow-up.

Effect on the musculosceletal system in women with dominant urinary stress incontinence after TVT or TVT-O

OpenAIRE

Klemp, Evelyn

2010-01-01

Introduction: According to current studies approximately 10-41% of the female population worldwide suffers from stress incontinence (SUI). After exhausting all conservative measures for treatment and clear indication the retropubic trans vaginal tape = TVT or the trans obturator tape = TVTO are the preferred operative interventions. Current publications frequently compare the two surgical options and also describe the occurrence of postoperative pain in the adductor muscles. None of the...

Comparison of the clinical and quality-of-life outcomes after the inside-out TVT-O procedure with or without concomitant transvaginal gynaecological surgery.

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Cho, M K; Kim, C H; Kang, W D; Kim, J W; Kim, S M; Kim, Y H

2012-04-01

The study was undertaken to compare the clinical and quality-of-life (QoL) outcomes of the inside-out transobturator vaginal tape (TVT-O)-only procedures and TVT-O procedures with concomitant transvaginal gynaecological surgery for the treatment of stress urinary incontinence (SUI). A review of charts from January 2006 to March 2010 identified 305 patients with urodynamic stress incontinence for whom we performed the TVT-O. Of the initial 305 patients, 272 (89.2%) were re-examined for complications 1 month, 4 months, 1 year and 2-4 years postoperatively (122 TVT-O only; 150 TVT-O + other transvaginal gynaecological surgery). They were also evaluated with the Urogenital Distress Inventory Questionnaire (UDI-6) and the Incontinence Impact Questionnaire (IIQ-7) 1-4 years after the procedure. The median follow-up was 37.3 months. The success rate was 89.3% in the TVT-O-only group vs 93.3% in the TVT-O with concomitant gynaecological surgery group (p =0.729). The QoL score was quite good for 91.8% of the TVT-O-only patients and for 96.7% of the TVT-O with concomitant gynaecologic surgery patients (p =0.405). In conclusion, gynaecological operations performed concomitantly with the TVT-O procedure do not affect the clinical and QoL outcomes of the TVT-O procedure.

Randomized controlled study of MONARC® vs. tension-free vaginal tape obturator (TVT-O®) in the treatment of female urinary incontinence: comparison of 3-year cure rates.

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Park, Yoo Jun; Kim, Duk Yoon

2012-04-01

Transobturator approaches to midurethral sling surgery are one of the most commonly performed operations for female stress urinary incontinence throughout the world. However, very few results of randomized clinical trials of transobturator midurethral sling surgery (MONARC vs. TVT-O) for the treatment of female urinary incontinence have been reported. In this study, we compared the 3-year follow-up cure rates of these two procedures. From July 2006 to June 2008, 74 patients who had undergone MONARC (35 patients) or TVT-O (39 patients) were included in the study and were analyzed prospectively. The mean follow-up duration of both groups was 39.2 months. Preoperative and postoperative evaluations included physical examination, uroflowmetry and postvoid residual measurement, involuntary urine loss with physical activity, and urinary symptoms. Cure of female urinary incontinence was defined as patient report of no loss of urine upon physical activity. The patients' satisfaction after treatment was rated as very satisfied, satisfied, equivocal, and unsatisfied. Very satisfied and satisfied were considered as the satisfied rate. There were no significant differences in preoperative patient characteristics, postoperative complications, or success rate between the two groups. The cure rate of the MONARC and TVT-O groups was 85.7% and 84.6%, respectively. The patient satisfaction (very satisfied, satisfied) rate of the MONARC and TVT-O groups was 82.8% and 82.1%, respectively. The MONARC and TVT-O procedures were equally efficient for the treatment of female urinary incontinence, with maintenance of high cure rates for 3 years. Longer follow-up is needed to confirm these results.

Binding and internalization of NGR-peptide-targeted liposomal doxorubicin (TVT-DOX) in CD13-expressing cells and its antitumor effects.

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Garde, Seema V; Forté, André J; Ge, Michael; Lepekhin, Eugene A; Panchal, Chandra J; Rabbani, Shafaat A; Wu, Jinzi J

2007-11-01

In an effort to develop new agents and molecular targets for the treatment of cancer, aspargine-glycine-arginine (NGR)-targeted liposomal doxorubicin (TVT-DOX) is being studied. The NGR peptide on the surface of liposomal doxorubicin (DOX) targets an aminopeptidase N (CD13) isoform, specific to the tumor neovasculature, making it a promising strategy. To further understand the molecular mechanisms of action, we investigated cell binding, kinetics of internalization as well as cytotoxicity of TVT-DOX in vitro. We demonstrate the specific binding of TVT-DOX to CD13-expressing endothelial [human umbilical vein endothelial cells (HUVEC) and Kaposi sarcoma-derived endothelial cells (SLK)] and tumor (fibrosarcoma, HT-1080) cells in vitro. Following binding, the drug was shown to internalize through the endosomal pathway, eventually leading to the localization of doxorubicin in cell nuclei. TVT-DOX showed selective toxicity toward CD13-expressing HUVEC, sparing the CD13-negative colon-cancer cells, HT-29. Additionally, the nontargeted counterpart of TVT-DOX, Caelyx, was less cytotoxic to the CD13-positive HUVECs demonstrating the advantages of NGR targeting in vitro. The antitumor activity of TVT-DOX was tested in nude mice bearing human prostate-cancer xenografts (PC3). A significant growth inhibition (up to 60%) of PC3 tumors in vivo was observed. Reduction of tumor vasculature following treatment with TVT-DOX was also apparent. We further compared the efficacies of TVT-DOX and free doxorubicin in the DOX-resistant colon-cancer model, HCT-116, and observed the more pronounced antitumor effects of the TVT-DOX formulation over free DOX. The potential utility of TVT-DOX in a variety of vascularized solid tumors is promising.

Annual Outcomes With Transcatheter Valve Therapy: From the STS/ACC TVT Registry.

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Holmes, David R; Nishimura, Rick A; Grover, Frederick L; Brindis, Ralph G; Carroll, John D; Edwards, Fred H; Peterson, Eric D; Rumsfeld, John S; Shahian, David M; Thourani, Vinod H; Tuzcu, E Murat; Vemulapalli, Sreekanth; Hewitt, Kathleen; Michaels, Joan; Fitzgerald, Susan; Mack, Michael J

2016-02-01

The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.

Long-term clinical outcomes with the retropubic tension-free vaginal tape (TVT) procedure compared to Burch colposuspension for correcting stress urinary incontinence (SUI).

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Holdø, Bjørn; Verelst, Margareta; Svenningsen, Rune; Milsom, Ian; Skjeldestad, Finn Egil

2017-11-01

The retropubic tension-free vaginal tape (TVT) procedure replaced Burch colposuspension as the primary surgical method for stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) in women in our department in 1998. In this study we compared the short-term and long-term clinical outcomes of these surgical procedures. Using a case series design, we compared the last 5 years of the Burch procedure (n = 127, 1994-1999) with the first 5 years of the retropubic TVT procedure (n = 180, 1998-2002). Information from the medical records was transferred to a case report form comprising data on perioperative and long-term complications as well as recurrence of UI, defined as bothersome UI or UI in need of repeat surgery. Other endpoints were rates of perioperative and late complications and the rates of prolapse surgery after primary surgery. The data were analyzed with the chi-squared and t tests and survival analysis using SPSS. The cumulative recurrence rate of SUI in women with preoperative SUI was significantly higher after the Burch procedure, but no difference was observed in women with MUI. There were no significant differences in rates of perioperative and late complications. At 12 years there was a significant increase in rates of repeat surgery for incontinence and prolapse in women after the Burch procedure. The long-term efficacy of TVT surgery was superior to that of Burch colposuspension in women with SUI. In addition, the rate of late prolapse surgery was significantly higher after the Burch procedure.

Midterm prospective evaluation of TVT-Secur reveals high failure rate.

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Cornu, Jean-Nicolas; Sèbe, Philippe; Peyrat, Laurence; Ciofu, Calin; Cussenot, Olivier; Haab, Francois

2010-07-01

TVT-Secur has been described as a new minimally invasive sling for women's stress urinary incontinence (SUI) management, showing promising results in short-term studies. Our goal was to evaluate the outcome of this procedure after a midterm follow-up. A prospective evaluation involved 45 consecutive patients presenting SUI associated with urethral hypermobility. Fourteen patients preoperatively reported overactive bladder (OAB) symptoms, but none had objective detrusor overactivity. Eight patients had low maximal urethral closure pressure (MUCP). Four patients had pelvic organ prolapse (POP). Patients with POP were treated under general anesthesia by Prolift and TVT-Secur procedure. The 41 other patients received TVT-Secur under local anesthesia on an outpatient basis. All interventions were made by the same surgeon. Postoperative assessment included pad count, bladder diary, clinical examination with stress test, evaluation of satisfaction with the Patient Global Impression of Improvement (PGI-I) scale, and evaluation of side effects. Patients were classified as cured if they used no pads, had no leakage, and had a PGI-I score 50% and PGI-I score TVT or transobturator tape during follow-up. Age, MUCP, or OAB were not associated with failure. Side effects were limited to five cases of de novo OAB and three cases of urinary tract infection. This work is limited by the absence of a comparison group. Our experience shows that despite its good short-term efficacy, TVT-Secur is associated with a high recurrence rate of SUI. Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women. Copyright 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Delayed vaginal and urethral mesh exposure: 10 years after TVT surgery.

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Khanuengkitkong, Siwatchaya; Lo, Tsia-Shu; Dass, Anil Krishna

2013-03-01

Delayed mesh exposure after tension-free vaginal tape (TVT) procedure is rare. We report a case of mesh exposure into the vagina and urethra that developed 10 years after TVT surgery. A 58-year-old postmenopausal woman presented with mixed urinary incontinence. She was investigated, and her stress urinary incontinence was cured with a TVT procedure 10 years ago. She was then scheduled follow-up annually. Two years postsurgery, a granulation tissue was observed and excised at the vaginal incision site. Vaginal examination 10 years postsurgery showed vaginal mesh erosion 0.5 cm from urethral meatus. Cystoscopy revealed concomitant urethral erosion at the posterior urethral wall. Mesh excision was performed, and urethra and vagina were repaired in layers. Postoperative recovery was uneventful. This finding shows that, although rare, complications can occur even after 10 years of TVT surgery.

Comparison of TVT, TVT-O/TOT and mini slings for the treatment of female stress urinary incontinence: 30 months follow up in 531 patients.

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Stavros, Charalambous; Ioannis, Vouros; Vasileios, Sakalis I; Gkotsi, Anastasia Ch; Georgios, Salpiggidis; Papathanasiou, Athanasios; Rombis, Vasileios

2012-09-01

Although mid-urethral slings (MUS), have been extensively used for the treatment of female stress urinary incontinence (SUI), no published data exists for the efficiency and the complications of these methods in large patient series. This is a retrospective analysis on patients who underwent MUS surgery since 1999. 531 patients were studied and the results of preoperative assessment, perioperative, early postoperatively and each follow up were registered. Patients were classified in three groups according to the MUS used. Efficacy of each method was evaluated in terms of early postoperative course, late complications and patient's symptoms improvement based questioners, pad test, uroflowmetry, filling cystometry and ultrasonography. Evaluation took place at 7th and 30th postoperative day, 3rd and 12th month and then annually. Each patient was characterized as cured, improved or failed. Trans Obturator (TO) group prevailed in efficiency with no significant differences between trans obturator route with inside-out (TVT-O) and outside-in (TOT). Success rate at 30th month evaluation, was higher in the TO group than in Tension-free Vaginal Tape (TVT) or Single-Incision Mini Slings (SIMS) group (93.4% vs 89.5%, 93.4% vs. 91.7%). None TVT patient required reoperation for remaining/reoccurring SUI, while 1.04% of TO group and 5.48% of SIMS group did. Patients of TVT group underwent reoperation for tape related complications in 2.25%, while 2.07% of TO group and none of SIMS group did. The potential limitation of the study is its retrospective character. Even though TO tapes and SIMS seem more efficient than TVT, they carry a risk of SUI re-occurrence that must be weighted towards the risk of potential complications after TVT.

Short-term effect of TVT-SECUR procedure on quality of life and sexual function in women with stress urinary incontinence.

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Tang, Xiang; Zhu, Lan; Zhong, Wen; Li, Bin; Lang, Jinghe

2013-01-01

To investigate whether patient quality of life and sexual function are improved after the tension-free vaginal tape SECUR (TVT-S) procedure (H-type). Prospective study (Canadian Task Force classification II-3). Single-center hospital. Thirty-three women with stress urinary incontinence (SUI) (high urethral mobility) and no concomitant pelvic floor prolapse underwent TVT-S between October 2009 and October 2011. TVT-S procedure. Before and after surgery(6 and 12 months), all patients completed the Chinese version of the Incontinence Quality of Life Questionnaire (I-QOL). In addition, 28 sexually active patients who underwent the TVT-S procedure completed the short-form Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) before and after surgery (6 and 12 months). We used a paired t test to compare I-QOL scores before and after surgery. The Wilcoxon signed-rank test was used to compare the preoperative and postoperative PISQ scores. The objective cure rate was 78% (26 of 33 patients) at 12 months after surgery. The objective improvement rate was 12.1% (4 of 33 patients). The subjective satisfaction rate was 90%. Three operations (9.1%) were considered failures. Two patients underwent a TVT procedure after TVT-S because of recurrence. No patients reported severe pain; the mean (SD) visual analog scale pain score was 1.8 (1.2) after surgery. Only 1 patient (3%) was found to have sling erosion at 12 months postoperatively. The I-QOL score was 28.3 (14.2) before surgery and increased to 69.5 (18.9) at 12 months after the TVT-S procedure. The I-QOL score improved significantly after surgery (p .05). Although the objective cure rate was not high, the TVT-S procedure is a minimally invasive, safe, and effective surgical procedure for treatment of SUI (high urethral mobility) and can improve the quality of life and sexual function in women with SUI. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

Bleeding complication with the TVT-Exact procedure: a report of two cases.

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Masata, Jaromir; Svabik, Kamil; Martan, Alois

2015-02-01

Midurethral tension-free vaginal tapes (TVT), placed through the retropubic space or through the obturator foramina, are widely used for the surgical treatment of female stress urinary incontinence. Some complications are associated with retropubic tapes owing to the passage of the tape through the space of Retzius. One of the most frequent complications is bleeding, and if injury to major vessels is involved, this may be life-threatening. In 2010, the Gynecare TVT-Exact® Continence System was introduced onto the market, with a rigid trocar shaft measuring 3.0 mm in diameter. We have no clinical data regarding the complication rate, especially concerning bleeding, connected with this device; all data are related to the original size of the TVT inserter. The cases presented demonstrate that bleeding complications can occur with the TVT-Exact procedure.

Matched-pair analyses of resting and dynamic morphology between Monarc and TVT-O procedures by ultrasound.

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Yang, Jenn-Ming; Yang, Shwu-Huey; Huang, Wen-Chen; Tzeng, Chii-Ruey

2013-07-01

To determine morphologic differences between Monarc and TVT-O procedures in axial and coronal planes by three- and four-dimensional (3D and 4D) ultrasound. Retrospective chart audits and ultrasound analyses were conducted on 128 women who had undergone either Monarc or TVT-O procedures for urodynamic stress incontinence. Thirty matched pairs of the two successful procedures were randomly selected and compared. Matched variables were age, parity, body mass index, cesarean status, menopausal status, and primary surgeries. Six-month postoperative 3D and 4D ultrasound results obtained at rest, on straining, and during coughing in these 60 women were analyzed. Assessed ultrasound parameters included the axial tape urethral distance (aTUD), axial central urethral echolucent area (aUCEA), axial tape angle (aTA), and coronal tape angle (cTA), all of which were measured at three equidistant points along the tapes. Paired t-tests were used to compare differences in ultrasound parameters between women after the two procedures and a P value TVT-O procedures. There were no significant differences in other resting ultrasound parameters between these two procedures. Additionally, after both procedures women had comparable straining and coughing ultrasound manifestations as well as respective dynamic changes. Despite flatter resting tape angulations in women following Monarc procedures, both Monarc and TVT-O tapes had equivalent dynamic patterns and changes assessed by 4D ultrasound. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Mid-term follow-up of the TVT-Secur midurethral sling for primary stress incontinence.

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Angleitner-Flotzinger, Johannes; Aigmueller, Thomas

2014-09-01

The TVT-Secur was introduced in 2006 as a less invasive alternative to retropubic and transobturator suburethral slings. This retrospective cohort study evaluated objective and subjective results in a series of 158 consecutive patients as well as complications and the reoperation rate after TVT-Secur procedure. Between November 2006 and June 2010 a total of 158 patients underwent a TVT-Secur procedure at a single institution. All patients underwent preoperative urodynamic testing. All patients were invited for follow-up including physical examination, urodynamic studies and subjective evaluation. A total of 96 patients (61%) were available for follow-up with a mean follow-up of 29.8 months (range 5-50, median 30). At follow-up, eight (8%) of 96 patients had reoperations for stress incontinence. There were no reoperations for bleeding/hematoma, tape erosions or obstructed micturition and there were no tape erosions or exposures. 29 patients (30%) had a negative cough stress test and 44 patients (46%) subjectively considered themselves "cured". Nine of 43 patients (21%) without urgency symptoms preoperatively developed de novo urgency; 24 of 35 patients (69%) with preoperative urgency complaints were free of urgency symptoms. At 2.4 years, the TVT-Secur appears to have a low adverse events profile but inferior results compared with traditional midurethral slings. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Assesment of patients treated with Tension free vaginal tape (TVT for stres urinary incontinence with quality of life tests.

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Özgür Özyüncü

2009-03-01

Full Text Available Objective: The aim of this study is to classify the patients with “Urinary incontinence score for females” test and than evaluation of the patients with quality of life tests before and after TVT procedure. Design: The history, physical examination, intraoperative complications, operation time and postoperative complications of patients were recorded. At the preoperative period “Urinary incontinence score for females” test were performed to all patients. To the patients in the stress, urge and mixed incontinence groups, UDI-6 (Urogenital Distress Inventory-6 and IIQ-7 (Incontinence Impact Questionairre-7 quality of life tests were performed preoperatively and at 6th week and 6th month postoperatively and results were then compared. Setting: Hacettepe University Hospital, Department of Obstetrics and Gynecology Patients: 94 patients in which TVT procedure was performed Interventions: TVT procedure was performed on 94 patients. The UDI-6 (Urogenital Distress Inventory-6 and IIQ-7 (Incontinence Impact Questionairre-7 quality of life tests were performed preoperatively postoperatively. Results: The mean age of the patients were 46,8 years. TVT procedure alone were performed in 8 patients. In addition to TVT, Anterior and posterior colporraphy is performed in 27, Vaginal hysterectomy and Unilateral/bilateral salphingoophorectomy is performed in 57 and manchester operation in 2 of the remaining patients. The most common intraoperative complication was bladder perforation (%15.9. When classified according to urinary incontinence score for females, the percentage of stress, urge and mixed incontinence groups were 36,2, 6,4 and 57,4 respectively and the success rate of TVT in these groups were 100%, 66.67% and 88.89% respectively. When preoperative and postoperatif IIQ-7 and UDI-6 scores were compared, the difference between scores were found to be statistically significant. Conclusions: When classification of patients were done with subjective

Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis

OpenAIRE

Wei Huang; Tao Wang; Huantao Zong; Yong Zhang

2015-01-01

Purpose: To assess the efficacy and safety of tension-free vaginal tape (TVT)-Secur for stress urinary incontinence (SUI). Methods: A literature review was performed to identify all published trials of TVT-Secur. The search included the following databases: MEDLINE, Embase, and the Cochrane Controlled Trial Register. Results: Seventeen publications involving a total of 1,879 patients were used to compare TVT-Secur with tension-free obturator tape (TVT-O) and TVT. We found that TVT-Secur had s...

[Study on concomitant surgical correction of pelvic organ prolapse and TVT-O for treatment of stress urinary incontinence].

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Wang, Su-mei; Zhang, Zhen-yu; Liu, Chong-dong; Wang, Shu-zhen

2013-07-01

To investigate the necessity, safety and efficacy of transobturator tension-free vaginal tape (TVT-O) for treatment of stress urinary incontinence (SUI) during transvaginal corrective operation of pelvic organ prolapse (POP). From Jan. 2005 to Dec. 2010, 92 patients undergoing transvaginal pelvic reconstruction surgery for correction of POP concomitant TVT-O for treatment of SUI in Department of Obstetrics and Gynecology affiliated to Beijing Chaoyang Hospital as concomitant surgery group were enrolled in this retrospective study matched with 90 patients with mild SUI without SUI surgery as non-concomitant surgery group and 120 patients without SUI as control group.Variable clinical index, clinical efficacy and complications were compared among those three groups. Compared with those in the other two groups, the mean age [(62 ± 11) years] was lower (P = 0.007,0.038), the operation time only slightly increased (12.8 min and 12.9 min respectively) significantly in concomitant TVT-O group. The bleeding loss and the length of staying hospital after operation all exhibited no significant differences within three groups (P > 0.05). The effective rate for SUI was 96.7% (89/92) in concomitant TVT-O group, corrective operation of POP was ineffective for 74.4% (67/90) SUI, 9.2% (11/120) patients presented new SUI in the patients without SUI preoperatively. TVT-O is a simple, safe and effective method in the treatment of SUI, which is more suitable for performing simultaneously during the corrective operation of POP.Efficacy of SUI correction was limited in those patients undergoing only pelvic reconstructive surgery. However, a preventive anti-incontinence procedure is not recommended because of the lower incidence in POP patients without SUI preoperatively.

Outcomes of glaucoma reoperations in the Tube Versus Trabeculectomy (TVT) Study.

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Saheb, Hady; Gedde, Steven J; Schiffman, Joyce C; Feuer, William J

2014-06-01

To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy (TVT) Study. Cohort study of patients in a multicenter randomized clinical trial. The TVT Study enrolled 212 patients with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. Randomization assigned 107 patients to surgery with a tube shunt (350 mm(2) Baerveldt glaucoma implant) and 105 patients to trabeculectomy with mitomycin C (0.4 mg/mL for 4 minutes). Data were analyzed from patients who failed their assigned treatment and had additional glaucoma surgery. Outcome measures included intraocular pressure (IOP), use of glaucoma medications, visual acuity, surgical complications, and failure (IOP >21 mm Hg or not reduced by 20%, IOP ≤5 mm Hg, additional glaucoma surgery, or loss of light perception vision). Additional glaucoma surgery was performed in 8 patients in the tube group and 18 patients in the trabeculectomy group in the TVT Study, and the 5-year cumulative reoperation rate was 9% in the tube group and 29% in the trabeculectomy group (P = .025). Follow-up (mean ± SD) after additional glaucoma surgery was 28.0 ± 16.0 months in the tube group and 30.5 ± 20.4 months in the trabeculectomy group (P = .76). At 2 years after a glaucoma reoperation, IOP (mean ± SD) was 15.0 ± 5.5 mm Hg in the tube group and 14.4 ± 6.6 mm Hg in the trabeculectomy group (P = .84). The number of glaucoma medications (mean ± SD) after 2 years of follow-up was 1.1 ± 1.3 in the tube group and 1.4 ± 1.4 in the trabeculectomy group (P = .71). The cumulative probability of failure at 1, 2, 3, and 4 years after additional glaucoma surgery was 0%, 43%, 43%, and 43%, respectively, in the tube group, and 0%, 9%, 20%, and 47% in the trabeculectomy group (P = .28). Reoperations to manage complications were required in 1 patient in the tube group and 5 patients in the trabeculectomy group (P = .63). The rate of reoperation for glaucoma was higher following

Efficacy and safety of the trans-obturator TVT-Abbrevo device in normal weight compared to overweight patients affected by stress urinary incontinence.

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Tommaselli, Giovanni A; Napolitano, Valerio; Di Carlo, Costantino; Formisano, Carmen; Fabozzi, Annamaria; Nappi, Carmine

2016-02-01

To investigate if TVT-Abbrevo has similar outcomes in normal weight and overweight patients. Retrospective evaluation of 205 (105 normal weight women and 100 overweight women with BMI ≥ 25 kg/m(2)) undergone TVT-Abbrevo positioning with 12 month follow-up. Primary outcomes were objective cure rate (defined as no leakage during CST) and subjective cure rate ("very much improved"/"much improved" at PGI-I), secondary outcomes were intra-operative and post-operative complications. Objective cure rates in the normal and overweight groups were 96.2% and 94%, respectively (p=.47). Subjective cure rates in the normal and overweight groups were 90.5% and 88%, respectively (p=.57). ICIQ-SF, I-QoL and PGI-S scores significantly improved in both groups with no differences between the two groups. No serious intra- or post-operative complications were observed. No differences were observed in pain VAS scores and number of analgesic vials administered. TVT-Abbrevo seems to have similar efficacy and safety in normal weight and overweight women. More studies are needed to assess the efficacy of this device in frankly obese women and long-term outcomes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

[Our experience with mini tapes (TVT Secur and MiniArc) in the surgery for stress urinary incontinence].

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Jiménez Calvo, J; Hualde Alfaro, A; Raigoso Ortega, O; Cebrian Lostal, J L; Alvarez Bandres, S; Jiménez Parra, J; Montesino Semper, M; Santiago Gonzalez de Garibay, A

2008-01-01

The purpose of this publication is to describe the surgical technique, assess complications and short-term results of TVT secur and MiniArc tapes. From October 2006 to August 2007 it was carried out the surgical correction with TVT Secur,Women's Health & Urology, Ethicon, Johnson & Johnson, placing the tape as a hammock, to 51 patients, 38 of them with pure stress incontinence and 13 with mixed incontinence and with an average age of 57 years. From September 2007 to February 2008 41 patients, 33 of them with pure stress incontinence and 8 with mixed incontinence, with an average of age of 58 years were operated with AMS Miniarc swing system tape, posted on hammock. All procedures were performed with sedoanalgesia and Ambulatory Surgery regime. Patients were monitored in outpatient visits one month, 3 months and one year after surgical procedure. Medical history and questionnaire and ICIQ-SF, to which we added a question to quantify the degree of satisfaction, as well as physical examination, were done. We compared the results of both technical procedures and statistical survey was conducted by Student test. [Analysis with SPSS software (V14.0)]. The median follow-up in TVT secur group was 328 days (range 163-522 days) and 101 days (range 41-209 days) inthe MiniArc group. We only had one (TVT secur group) surgical complication in all the series (92 patients) being a bladder perforation. Taking into account that we read a negative test effort as an objective cure in the TVT secur group, 80.4% patients are cured and 90.2% inthe MiniArc group without significant difference between both groups (p 0095). To assess the subjective healing we utilized the ICIQ-SF test and the satisfaction extra-question and we noted that there is no significant difference between the first and third month controls. (90% of patients satisfied). 80% of patients were completely satisfied in the first year control that was only performed to TVT secur group. These new tapes show fewer

Sexual function and quality of life following retropubic TVT and single-incision sling in women with stress urinary incontinence: results of a prospective study.

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Naumann, Gert; Steetskamp, Joscha; Meyer, Mira; Laterza, Rosa; Skala, Christine; Albrich, Stefan; Koelbl, Heinz

2013-05-01

The objective of this prospective cohort study was to compare effectiveness, morbidity, quality of life (QoL) and sexual function in women treated with tension-free vaginal tape (TVT) versus single-incision sling (SIS) in the treatment of female stress urinary incontinence (SUI). Retropubic TVT sling or SIS was implanted in local anesthesia and patients were followed post-operatively for 6 months. Evaluation was performed to assess post-operative rate of continence, complications, changes in sexual function and patient reported quality of life. Female sexual function was evaluated before and after sling procedure using Female Sexual Function Index (FSFI) in sexually active patients. From January 2009 to December 2011, 150 patients were enrolled and underwent a procedure to implant the retropubic TVT (n = 75) or the MiniArc(®) and Ajust(®) SIS (n = 75). Overall, 93.3 % of the patients who successfully received SIS demonstrated total restoration (84 %) or improvement of continence (9.3 %) at the 6 month post-operative study visit. In TVT group we found 88 % total continence and 6.7 % improvement, respectively. Improvements were seen in the QoL scores related to global bladder feeling (89.3 %) in SIS group and 96 % for TVT. Post-operative FSFI score improves significantly and were comparable in both groups (SIS pre-operative 24.30 ± 4.56 to 27.22 ± 4.66 (P TVT 24.63 ± 6.62 to 28.47 ± 4.41, respectively). The SIS procedure appears to be as effective in improving incontinence-related quality of life and sexual function as the TVT through 6 months of post-operative follow-up. No differences in complications and sexual function were demonstrated between the groups.

Effects of a modified technique for TVT-O positioning on postoperative pain: single-blind randomized study.

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Tommaselli, Giovanni A; Formisano, Carmen; Di Carlo, Costantino; Fabozzi, Annamaria; Nappi, Carmine

2012-09-01

One of the most frequent and distressing complications of the tension-free vaginal tape obturator (TVT-O) procedure for stress urinary incontinence (SUI) is groin pain, which may be related to the surgical technique or to the tape. The aim of this study was to evaluate the impact of a more limited dissection and a more medial trocar trajectory in TVT-O positioning on postoperative pain. Seventy-two SUI patients were randomized to undergo TVT-O either with the traditional technique (group A) or a modified procedure (reduced paraurethral dissection and a more medial trocar trajectory) (group B). Visual analog scale pain scores 12 h, 24 h, and 1 month after the procedure, number of analgesic vials, objective cure rate, and patient functional and quality of life scores 6 months after the procedure were evaluated. Data were analyzed by the Student's t test for parametric variables, the Mann-Whitney U and Wilcoxon tests for nonparametric variables, and Fisher's exact test for categorical variables. Pain scores were significantly lower in group B compared with group A 24 h after surgery (P = 0.01). Pain scores significantly decreased from 12-24 h postoperatively to 1 month follow-up in both groups (P TVT-O seem to reduce postoperative groin pain at 24 h after the procedure, but not the analgesic requirement.

Comparison of Effectiveness between Tension-Free Vaginal Tape (TVT) and Trans-Obturator Tape (TOT) in Patients with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency.

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Kim, Hyeong Gon; Park, Hyoung Keun; Paick, Sung Hyun; Choi, Woo Suk

2016-01-01

The aim of this study was to compare the two types of mid-urethral slings for stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD). This retrospective study included patients who underwent tension-free vaginal tape (TVT) procedure or transobturator tape (TOT) procedure by a single surgeon for SUI with ISD, defined as Valsalva leak point pressure (VLPP) TVT and 52 patients received TOT. Age, underlying diseases, Stamey grade, cystocele grade, and presence of urge incontinence were not significantly different between the two groups. Urodynamic parameters including maximal urethral closing pressure, detrusor overactivity, VLPP, urethral hypermobility (Q-tip ≥ 30°), were also comparable between the two groups. Success rate was significantly higher in the TVT group than in the TOT group (95.2% vs. 82.7%, p = 0.009). On multivariate analysis, only TOT surgery (OR = 3.922, 95%CI = 1.223-12.582, p = 0.022) was a risk factor for failure following surgical treatment. TVT is more effective than TOT in treatment of female SUI with ISD.

Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis

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Wei Huang

2015-12-01

Full Text Available Purpose: To assess the efficacy and safety of tension-free vaginal tape (TVT-Secur for stress urinary incontinence (SUI. Methods: A literature review was performed to identify all published trials of TVT-Secur. The search included the following databases: MEDLINE, Embase, and the Cochrane Controlled Trial Register. Results: Seventeen publications involving a total of 1,879 patients were used to compare TVT-Secur with tension-free obturator tape (TVT-O and TVT. We found that TVT-Secur had significant reductions in operative time, visual analog score for pain, and postoperative complications compared with TVT-O. Even though TVT-Secur had a significantly lower subjective cure rate (P<0.00001, lower objective cure rate (P<0.00001, and higher intraoperative complication rate, compared with TVT-O at 1 to 3 years, there was no significant difference between TVT-Secur and TVT-O in the subjective cure rate (odds ratio [OR], 0.49; 95% confidence interval [CI], 0.22–1.08; P=0.08, objective cure rate (OR, 0.49; 95% CI, 0.22–1.09; P=0.08, or complications at 3 to 5 years. Moreover, TVT-Secur had significantly lower subjective and objective cure rates compared with TVT. Conclusions: This meta-analysis indicates that TVT-Secur did not show an inferior efficacy and safety compared with TVT-O for SUI in 3 to 5 years, even though displaying a clear tread toward a lower efficacy in 1 to 3 years. Considering that the safety is similar, there are no advantages in using TVT-Secur.

Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis

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Wang, Tao; Zhang, Yong

2015-01-01

Purpose: To assess the efficacy and safety of tension-free vaginal tape (TVT)-Secur for stress urinary incontinence (SUI). Methods: A literature review was performed to identify all published trials of TVT-Secur. The search included the following databases: MEDLINE, Embase, and the Cochrane Controlled Trial Register. Results: Seventeen publications involving a total of 1,879 patients were used to compare TVT-Secur with tension-free obturator tape (TVT-O) and TVT. We found that TVT-Secur had significant reductions in operative time, visual analog score for pain, and postoperative complications compared with TVT-O. Even though TVT-Secur had a significantly lower subjective cure rate (PTVT-O at 1 to 3 years, there was no significant difference between TVT-Secur and TVT-O in the subjective cure rate (odds ratio [OR], 0.49; 95% confidence interval [CI], 0.22–1.08; P=0.08), objective cure rate (OR, 0.49; 95% CI, 0.22–1.09; P=0.08), or complications at 3 to 5 years. Moreover, TVT-Secur had significantly lower subjective and objective cure rates compared with TVT. Conclusions: This meta-analysis indicates that TVT-Secur did not show an inferior efficacy and safety compared with TVT-O for SUI in 3 to 5 years, even though displaying a clear tread toward a lower efficacy in 1 to 3 years. Considering that the safety is similar, there are no advantages in using TVT-Secur. PMID:26739179

Comparison of TVT and TOT on urethral mobility and surgical outcomes in stress urinary incontinence with hypermobile urethra.

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Cavkaytar, Sabri; Kokanalı, Mahmut Kuntay; Guzel, Ali Irfan; Ozer, Irfan; Aksakal, Orhan Seyfi; Doganay, Melike

2015-07-01

To compare the change of urethral mobility after midurethral sling procedures in stress urinary incontinence with hypermobile urethra and assess these findings with surgical outcomes. 141 women who agreed to undergo midurethral sling operations due to stress urinary incontinence with hypermobile urethra were enrolled in this non-randomized prospective observational study. Preoperatively, urethral mobility was measured by Q tip test. All women were asked to complete Urogenital Distress Inventory Short Form (UDI-6) and Incontinence Impact Questionnaire Short Form (IIQ-7) to assess the quality of life. Six months postoperatively, Q tip test and quality of life assessment were repeated. The primary surgical outcomes were classified as cure, improvement and failure. Transient urinary obstruction, de novo urgency, voiding dysfunction were secondary surgical outcomes. Of 141 women, 50 (35. 5%) women underwent TOT, 91 (64.5%) underwent TVT. In both TOT and TVT groups, postoperative Q tip test values, IIQ-7 and UDI-6 scores were statistically reduced when compared with preoperative values. Postoperative Q tip test value in TVT group was significantly smaller than in TOT group [25°(15-45°) and 20° (15-45°), respectively]. When we compared the Q-tip test value, IIQ-7 and UDI-6 scores changes, there were no statistically significant changes between the groups. Postoperative urethral mobility was more frequent in TOT group than in TVT group (40% vs 23.1%, respectively). Postoperative primary and secondary outcomes were similar in both groups. Although midurethral slings decrease the urethtal hypermobility, postoperative mobility status of urethra does not effect surgical outcomes of midurethral slings in women with preoperative urethral hypermobility. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Short-term clinical and quality-of-life outcomes in women treated by the TVT-Secur procedure.

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Lim, Jeanette L; de Cuyper, Eva M J; Cornish, Ann; Frazer, Malcolm

2010-04-01

The TVT-Secur (Ethicon, Somerville, NJ, USA) is a minimally invasive suburethral synthetic sling used in the treatment of female stress urinary incontinence. It claims to cause less postoperative pain and to enable performing in an office setting. However, this may be at the expense of a significant learning curve and a higher early failure rate. To assess objectively the success rate of the TVT-Secur procedure in the 'U' configuration at six months. Secondary outcomes focussed on subjective success rates, complications, patient satisfaction and quality-of-life (QOL). A prospective observational study was undertaken at two tertiary referral urogynaecology centres. A cohort of 42 consecutive patients with urodynamic stress incontinence who underwent the TVT-Secur procedure in the 'U' configuration between November 2006 and August 2007 were followed up for six months. Three standardised QOL questionnaires were completed preoperatively and at six months. A urogenital history, visual analogue score (VAS) for patient satisfaction, uroflow and urinary stress test were performed at six months. Recruitment was ceased prematurely because of a high number of early failures. Objective and subjective success rates at six months were 58.3% and 51.3% respectively. Complications included urinary tract infections, voiding difficulty, groin discomfort, haematoma, vaginal pain, tape erosion and intra-operative dislodgement of tape. Prevalence of de novo urge incontinence was 10.3%. Only symptom-specific QOL scores improved and only 48.6% indicated a high level satisfaction (VAS > or = 80%) with TVT-Secur. On the basis of this limited study, we are hesitant to recommend the 'U' configuration of the TVT-Secur over its more established counterparts, the TVT and TVT-O.

EFFECT OF MID URETHRAL SLING (TVT SURGERY ON FEMALE SEXUAL FUNCTION

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Ramesh

2015-09-01

Full Text Available INTRODUCTION: Mid Urethral Slings is the main stay of therapy in the management of stress urinary incontinence in the female, w e evaluated the effect of TVT on sexual function in women who are from the rural backward districts of Rayalaseema districts of Andhra Pradesh. MATERIALS & METHODS: 30 Women with a mean age of 44 yrs with SUI were evaluated before TVT procedure and then every 3months for 1yr for sexual health using NSF - 9 questionnaire . RESULTS: The sexual function in all the domains including desire, frequency ar ousal , orgasm remained the same as before surgery in more than 80% pts. The satisfaction rate was better in pts who were leaking during sex before surgery in six out of ten patients. CONCLUSIONS: TVT surgery does not have any significant impact on sexual function Sexual function is not an important issue for the female beyond the age of 40 yrs in the perimenopau s e/ post menopause period

Adjustable mini-sling compared to conventional mid-urethral slings in women with urinary incontinence

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Rudnicki, Martin; von Bothmer-Ostling, Katarina; Holstad, Anja

2017-01-01

INTRODUCTION: The primary aim was to compare the objective and subjective outcomes and short-term complication rates of an adjustable single-incision mini-sling (SIMS) versus standard mid-urethral slings (SMUS). The secondary aim was reporting pain perception and complications at one-year follow......-up. MATERIAL AND METHODS: The study was designed as a multicenter prospective randomized trial where women were included by eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials. gov: NCT01754558. A total of 305 women less than 60 years old with verified stress urinary...... incontinence were included. All women were randomized to SIMS (Ajust(®) ; N=155) or SMUS (TVT, TVT-O or TOT; N=150) and were evaluated by stress test and bladder diary before and after surgery and symptoms related to incontinence using ICIQ-SF, PISQ-12 and PGI-S and PGI-I. Objective cure was defined...

Anatomical variability in the trajectory of the inside-out transobturator vaginal tape technique (TVT-O)

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Hinoul, Piet; Vanormelingen, Linda; Roovers, Jan-Paul; de Jonge, Eric; Smajda, Stéfan

2007-01-01

An experimental surgical study on human cadavers was undertaken to assess variability in the trajectory followed by the needle during application of the inside-out transobturator tape suspension (TVT-O) technique. The TVT-O surgical procedures were performed on six fresh female cadavers according to

Efficacy and safety of the TVT-SECUR® and impact on quality of life in women with stress urinary incontinence: a 2-year follow-up.

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Shin, Yu Seob; Cha, Jai Seong; Cheon, Min Woo; Kim, Young Gon; Kim, Myung Ki

2011-05-01

As recently reported, the short-term results of the tension-free vaginal tape SECUR® (TVT-S) procedure seem to be similar to those of the conventional transobturator tape (TOT) procedure. However, results of efficacy and satisfaction with TVT-S are insufficient in patients with more than 1 year of follow-up. Therefore, we evaluated the results of the TVT-S procedure in women with stress urinary incontinence (SUI) during 2 years. We evaluated 51 patients with clinical and urodynamic diagnoses of SUI who underwent the TVT-S procedure from March 2008 to February 2009. Preoperative evaluation included a history, cough stress test with full bladder, urodynamic study, and incontinence quality of life (I-QoL) questionnaire. Following the postoperative period, urinary incontinence status was examined through a physical examination and the I-QoL questionnaire was completed in an outpatient setting or by telephone. Data from 2 years of follow-up were available for 46 of 51 patients. The cure rate was 80.4% at 1 month after TVT-S and 76.0% at 2 years after TVT-S. The cure or improvement rate was 93.5% at 1 month after TVT-S and 86.8% at 2 years after TVT-S. The mean total I-QoL score increased by 42 points at 1 month after TVT-S (pTVT-S (pTVT-S. The results of this study suggest that TVT-S is an efficient and safe procedure for the improvement of both the quality of life of the patients and the SUI itself.

Randomized Comparative Study of the U- and H-Type Approaches of the TVT-Secur Procedure for the Treatment of Female Stress Urinary Incontinence: One-Year Follow-Up

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Kim, Jung Jun; Lee, Young-Suk

2010-01-01

Purpose We compared outcomes of the U- and H-type approaches of the tension-free vaginal tape (TVT)-Secur procedure for the treatment of female stress urinary incontinence (SUI). Materials and Methods From March 2007 to July 2008, 115 women with SUI underwent TVT-Secur by a single surgeon. Patients were randomly assigned to either the U- or the H-type approach. After 12 months, postoperative changes in the Sandvik questionnaire, incontinence quality of life questionnaire (I-QoL), Bristol female lower urinary tract symptoms-scored form (BFLUTS-SF), and postoperative patient satisfaction were evaluated. Cure was regarded as no leakage on the Sandvik questionnaire. Complications were also evaluated. Results Of 115 women, 53 were treated with the U approach, and 62 women were treated with the H approach. At 12 months, 88.7% of those treated with the U approach and 87.1% of those treated with the H approach were cured (p=0.796). The I-QoL and filling, incontinence, sexual function, and QoL sum (BFLUTS-SF) scores were improved with both approaches, and there were no significant differences in the degree of improvement between approaches. Approximately 83.7% and 82.9% of the women treated with the U and H approaches, respectively, were satisfied with the outcome (p=0.858). There were 3 cases of intra-operative vaginal wall perforation in the H-type group. Immediate postoperative retention was observed in 2 women in the U-type group and 1 woman in the H-type group. One woman in the U-type group underwent tape releasing and cutting procedures for persistent large post-void residuals. Conclusions The U- and the H-type approaches of the TVT-Secur procedure provided comparable effectiveness for the treatment of female SUI. PMID:20428427

Evaluation of the InFocus TVT-6000 LCTV

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Duffey, Jason N.; Jones, Brian K.; Gregory, Don A.; McClain, John L., Jr.

1994-03-01

Liquid crystal televisions have become increasingly popular as low-cost spatial light modulators. While the early devices suffered from poor resolution and low contrast, recent models compare favorably to the more traditional (and expensive) modulators. One of the most recent LCTVs is found in the InFocus TVT-6000 television projector. The panels in this projector have 480 X 440 pixels with a 1.32' diagonal clear aperture. A wavefront splitting interferometer has been constructed and analyzed for measuring the complex characteristics of these modulators, including phase and amplitude coupling. The results of this evaluation will be presented.

SUBJECTIVE CURE RATES AFTER TVT PROCEDURE FOR TREATMENT OF FEMALE URINARY INCONTINENCE – A QUESTIONNAIRE BASED STUDY

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Igor But

2003-12-01

Full Text Available Background. The aim of this study was to assess the subjective cure rate after the tension-free vaginal tape (TVT procedure in patients with stress (SUI and mixed (MUI urinary incontinence.Methods. This is a questionnaire based study done in 43 patients with SUI and 52 patients with MUI. In the assessement of the subjective cure rate the visual analogue scale and the symptom assessment index (SAI were used. Data were analyzed using nonparametric statistics.Results. The subjective cure rate assessed 19.6 months after TVT amounted to 89.3%. Urinary incontinence after TVT procedure was noted in 26 patients (27.4% and the majority of these women (73.1% were diagnosed with MUI. In patients with SUI and postoperative stable bladder a higher success rate was observed (96.7%. In 18.6% patients with SUI, de novo overactive bladder symptoms occurred. These patients estimated a significantly (p = 0.027 lower cure rate (81.9% after TVT procedure. In patients with MUI, the cure rate after TVT amounted to 85.6%. The subjective cure rate was lower (79.4% in case of persistent overactive bladder symptoms. However, it was significantly higher (97.5% in case of a postoperatively stable bladder (p = 0.016. In the group of MUI patients, the symptoms of overactive bladder disease resolved spontaneously in 17 patients (32.7% postoperatively. The patients were satisfied with TVT and 92.6% would recommend this procedure to others.Conclusions. The TVT procedure is a very effective method of treatment for stress as well as mixed urinary incontinence. The success rate of the procedure is high, however, it is influenced by bladder activity.

Outcome of TVT operations in women with low maximum urethral closure pressure.

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Moe, Kjartan; Schiøtz, Hjalmar A; Kulseng-Hanssen, Sigurd

2017-06-01

(i) To establish whether low maximal urethral closure pressure (MUCP) is associated with a poorer prognosis after TVT-surgery, and if so to establish an MUCP cut-off value for poor outcome. (ii) To characterize the population with a low MUCP. Retrospective analysis of data from 6,646 women with stress/mixed urinary incontinence included in the Norwegian Female Incontinence Registry. Postoperative subjective (degree of satisfaction), objective (leakage on stress test) and composite cure according to preoperative MUCP were analyzed in unadjusted and adjusted analysis. Preoperative variables were compared between women having a low or normal MUCP. Non-parametric tests were used on continuous variables and χ 2 tests on categorical variables. Logistic regression was used for the adjusted analysis. Level of significance: P 20 cm H 2 O. In adjusted analysis MUCP ≤20 cm H 2 O was associated with neither objective, subjective, nor composite failure. Women with MUCP TVT-surgery compared to women with MUCP >20 cm H 2 O after adjusting for preoperative variables. Neurourol. Urodynam. 36:1320-1324, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

TOT versus TVT – mesh surgical treatment in stress urinary incontinence

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Ovidiu Bratu

2015-12-01

Full Text Available Introduction: Stress urinary incontinence is a highly debilitating condition, with an important impact over the quality of life. When the conservative treatment fails, the surgical treatment is a viable solution. Minimally invasive sling procedures have become the gold standard of surgical management for stress urinary incontinence (SUI in women. Material and methods: The study was conducted on 68 patients with stress urinary incontinence, 52 have undergone the retropubic tension-free vaginal tape and 16 patients were operated using the transobturator tape procedure. All the patients were evaluated before the operation and the indication of the surgical treatment was established on the basis of physical examination (all the patients had positive cough test, abdominal ultrasound (to determine postvoid residual urine volume, urinalysis and urine culture (the majority of the patients have had before the operation recurrent urinary tract infections. Results: The satisfaction was similar in both groups of patients, with an average satisfaction rate of 91% for TVT and 86% for the patients who have undergone TOT procedure. The patients were in a proportion of 78,9% at menopause, with an average number of natural births of 1.9 and a mean BMI of 28.2. Regarding the surgical duration, this has varied between 20 and 40 minutes, being higher in the TVT cases (up to 5-7 minutes longer than TOT, because cystoscopy was performed during the operation to verify if the bladder was perforated or not. The urethral catheter was removed immediately after the operation in the case of the TOT procedure and in the day after the operation for the patients who have undergone TVT procedures (all of these patients associated genital prolapse. The hospitalization time was 3 days. We haven’t encountered significant intraoperative and postoperative complications. Conclusions: The TOT and TVT procedures have proven to be highly effective and safe methods in the treatment of

The TVT Glass Pavilion: Theoretical Study on a Highly Transparent Building Made with Long-Spanned TVT Portals Braced with Hybrid Glass-Steel Panels

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Maurizio Froli

2017-06-01

Full Text Available In contemporary buildings, the architectural demand for a complete dematerialisation of load bearing structures can be satisfied only in limited cases with the exclusive structural use of glass. Otherwise, for challenging applications such as long spanned or high-rise structures, the use of hybrid glass-steel systems is mandatory. Glass, fragile but highly compressive resistant, is associated with steel, ductile and tensile resistant. The present research shows the feasibility study for a fully glazed pavilion made of six TVT (Travi Vitree Tensegrity portal frames longitudinally braced by pre-stressed hybrid glass panels. The frames are about 20 m in span and 8 m in height. Appropriate multiscalar FEM numerical analyses, calibrated on the collapse tests performed on previous TVT large-scale prototypes, stated that the structural performance would be able to withstand heavy static and dynamic loads and stated the observance of the Fail-Safe Design principles.

TVT-ABBREVO: efficacy and two years follow-up for the treatment of stress urinary incontinence.

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Capobianco, G; Dessole, M; Lutzoni, R; Surico, D; Ambrosini, G; Dessole, S

2014-01-01

To assess the effectiveness of inside-out TVT-ABBREVO in the surgical treatment of female stress urinary incontinence (SUI) with mean two-year follow-up. Fifty-six women underwent surgery for moderate-severe SUI. The technology used was the TVT-ABBREVO inside-out. Each woman at 12 and 24 months underwent postoperative evaluation by means of urodynamics, Q-tip test, CST, transperineal ultrasonography, and administration of "King's Health Questionnaire" (KHQ). The mean age of the women was 57.03 +/- 11.1 years (range 42-75). Postoperative urodynamics (12 months follow-up) resulted to be normal in 43/56 patients (76.79%), in 10/56 (17.86%) cases resulted in a considerable improvement of the symptomatology, and only 1/56 (1.78%) case had de novo overactive bladder (OAB), in 2/56 (3.57%) symptomatology unchanged. After administration of the KHQ 43/56 cases (76.79%) had resolution of the symptomatology, 10/56 cases (17.86%) improvement of the symptomatology, and no change in 3/56 cases (5.36%). In the authors' experience, the TVT-ABBREVO resulted technically simple. The TVT-ABBREVO procedure provides high objective and subjective long-term efficacy, a clinically meaningful improvement in patient quality of life, and an excellent safety profile.

A multicentre prospective randomised study of single-incision mini-sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes.

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Mostafa, Alyaa; Agur, Wael; Abdel-All, Mohamed; Guerrero, Karen; Lim, Chi; Allam, Mohamed; Yousef, Mohamed; N'Dow, James; Abdel-fattah, Mohamed

2012-11-01

To compare the postoperative pain profile, peri-operative details, and short-term patient-reported and objective success rates of single-incision mini-slings (SIMS) versus standard mid-urethral slings (SMUS). In a multicentre prospective randomised trial in six UK centres in the period between October 2009 and October 2010, 137 women were randomised to either adjustable SIMS (Ajust®, C. R. Bard Inc., NJ, USA), performed under local anaesthesia as an opt-out policy (n=69), or SMUS (TVT-O™, Ethicon Inc., Somerville, USA) performed under general anaesthesia (n=68). Randomisation was done through number-allocation software and using telephone randomisation. Postoperative pain profile (primary outcome) was assessed on a ten-point visual analogue scale at fixed time-points. Pre- and post operatively (4-6 months) women completed symptom severity, urgency perception scale (UPS), quality of life and sexual function questionnaires. In addition, women completed a Patient Global Impression of Improvement Questionnaire and underwent a cough stress test at 4-6 months follow up. Sample size calculation was performed and data were analysed using SPSS 18. Descriptive analyses are given and between-group comparisons were performed using chi-square, Fischer exact test and Mann-Whitney test as appropriate. Significance level was set at 5%. Women in the SIMS Ajust® group had a significantly lower postoperative pain profile up to 4 weeks (p=TVT-O™ groups respectively. There was a trend towards higher rates of de novo urgency or worsening of pre-existing urgency in the SIMS Ajust® group (21.7% versus 8.8%) but this did not reach statistical significance (p=0.063). Women in the SIMS Ajust® group had shorter hospital stay (median (IQR) 3.65 (2.49, 4.96)) compared to (4.42 (3.16, 5.56)) the TVT-O™ group 95% CI (-0.026, 1.326), with significantly earlier return to normal activities (p=0.025) and to work (p=0.006). The adjustable single-incision mini-sling (Ajust®) is associated

TVT ABBREVO: cadaveric study of tape position in foramen obturatum and adductor region.

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Hubka, Petr; Nanka, Ondrej; Masata, Jaromir; Martan, Alois; Svabik, Kamil

2016-07-01

The aim of the study was to describe fixation of the TVT ABBREVO and establish whether the tape penetrates through obturator muscles and membrane (obturator complex) into the adductor region and, if so, how far it penetrates. Eight formalin-embalmed female cadavers were used to simulate TVT ABBREVO surgery (totalling 16 insertions). Following tape insertion, dissection was performed and ends of the tape were identified. In cases of penetration, the length of tape penetrating into the adductor region was measured. Of the 16 cases, the tape ended in the obturator membrane in eight, in the internal obturator muscle in one, and penetrated through the obturator membrane into the external obturator muscle in five, where it remained. In two cases, it penetrated through the obturator internus muscle, obturator membrane and obturator externus muscle into the group of thigh adductors; one penetration was by 3 mm and the second by 10 mm. No contact with the obturator nerve or its branches was noted in any case. No TVT contact with the obturator nerve was noted; tape penetrated into the adductor region in two of the 16 cases.

“U-Method” TVT-Secur Slings: Are they obstructive?

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Richard, Patrick; Gagnon, Louis-Olivier; Tu, Le Mai

2012-01-01

Introduction: The TVT-Secur, a single incision sling, was introduced in 2006. It is implanted using either the “hammock” or the “U-method” technique. With the latter, the sling is tightened to create a “pillowing effect” on the urethra until a negative stress test is obtained. Short-term results seem promising. However, no study has ever reported on the voiding pattern 12 months after its implantation. Our objective was to assess whether the “U-method” technique creates an obstructive voiding pattern on pressure-flow study (PFS) 12 months after the surgery. Methods: In this retrospective study, we reviewed the charts of 33 women who underwent the “U-method” TVT-Secur. Patients were evaluated before and 12 months postoperatively with regard to different urodynamic studies (UDS). The incontinence status was also assessed 12 months after surgery. Results: At 12 months after the operation, 12.5% (4/32) of the patients reported an improvement of their stress urinary incontinence, while 78.1% (25/32) reported being cured from it. The objective cure rate was 63% (19/30). One patient had a suspected bladder outlet obstruction (BOO) based on PFS. Maximal flow rate (Qmax) was significantly lower 12 months after surgery (26.0 mL/s [range: 19.0–36.5] vs. 21.5 mL/s [range: 16.0–32.3]). However, median voided volume was lower on the postoperative uroflowmetry (446 mL [range: 348–605] vs. 320 mL [range: 243–502]). Furthermore, none of the patients complained of voiding symptoms after surgery. Conclusions: Although one patient had findings compatible with BOO, none complained of voiding symptoms. TVT-Secur may result in a lower Qmax. However, this finding may be due to a lower voiding volume on the postoperative UDS. PMID:22511425

Optical characterization of the InFocus TVT-6000 liquid crystal television (LCTV) using custom drive electronics

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Duffey, Jason N.; Jones, Brian K.; Loudin, Jeffrey A.; Booth, Joseph J.

1995-03-01

Liquid crystal televisions are popular low-cost spatial light modulators. One LCTV of interest is found in the InFocus TVT-6000 television projector. A wavefront splitting interferometer has been constructed and analyzed for measuring the complex characteristics of these modulators, including phase and amplitude coupling. The results of this evaluation using the TVT-6000 projector drive electronics have been presented in a previous work. This work will present results of the complex characterizations of these modulators using custom drive electronics.

Long-term outcomes of TOT and TVT procedures for the treatment of female stress urinary incontinence: a systematic review and meta-analysis.

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Leone Roberti Maggiore, Umberto; Finazzi Agrò, Enrico; Soligo, Marco; Li Marzi, Vincenzo; Digesu, Alex; Serati, Maurizio

2017-08-01

One of the most relevant topics in the field of pelvic floor dysfunction treatment is the long-term efficacy of surgical procedures, in particular, the use of prosthesis. Hence, a systematic review and meta-analysis was conducted to evaluate the long-term effectiveness and safety of midurethral sling (MUS) procedures for stress urinary incontinence (SUI), as reported in randomised controlled trials (RCTs) and non-randomised studies. This systematic review is based on material searched and obtained via PubMed/Medline, Scopus, and the Cochrane Library between January 2000 and October 2016. Peer-reviewed, English-language journal articles evaluating the long-term (≥5 years) efficacy and safety of MUS in women affected by SUI were included. A total of 5,592 articles were found after the search, and excluding duplicate publications, 1,998 articles were available for the review process. Among these studies, 11 RCTs (0.6%) and 5 non-RCTs (0.3%) could be included in the qualitative and quantitative synthesis. Objective and subjective cumulative cure rates for retropubic technique (TVT) and transobturator tape (TOT; both out-in and in-out) were 61.6% (95% CI: 58.5-64.8%) and 76.5% (95% CI: 73.8-79.2%), and 64.4% (95% CI: 61.4-67.4%) and 81.3% (95% CI: 78.9-83.7%) respectively. When considering TOT using the out-in technique (TOT-OI) and TOT using the in-out technique (TVT-O) the objective and subjective cumulative cure rates were 57.2% (95% CI: 53.7-60.7%) and 81.6% (95% CI: 78.8-84.4%), and 68.8% (95% CI: 64.9-72.7%) and 81.3% (95% CI: 77.9-84.7%) respectively. Furthermore, this article demonstrates that both TVT and TOT are associated with similar long-term objectives (OR: 0.87 [95% CI: 0.49-1.53], I 2  = 67%, p = 0.62) and subjective (OR: 0.84 [95% CI: 0.46-1.55], I 2  = 68%, p = 0.58) cure rates. Similarly, no significant difference has been observed between TTOT-OI and TVT-O) in objective (OR: 3.03 [95% CI: 0.97-9.51], I 2  = 76%, p = 0

Surgical treatment of female stress urinary incontinence with the Gynecare TVT Secur™ System – preliminary report

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Włodzimierz Baranowski

2010-02-01

Full Text Available Introduction: Sling procedures were first introduced over 100 years ago in the treatment of stress urinaryincontinence. Since then they have evolved to become less invasive and safer. The sling procedure using theGynecare TVT Secur™ system is a new therapeutic option for women with stress urinary incontinence.Objectives: To evaluate the efficacy and safety of Gynecare TVT Secur™ in the surgical treatment of stressurinary incontinence in women. Material and methods: The study comprised consecutive female patients admitted to the Department ofGynaecology and Gynaecological Oncology of the Military Institute of Health Services in Warsaw, Poland, whohad been qualified for surgical treatment of stress urinary incontinence on the basis of physical signs and symptomsand the findings of a urodynamic study. The procedure was performed using the Gynecare TVT Secur™system with tapes introduced in an H- or U-shape mode. Results: Between October 2006 and September 2009, 77 sling procedures using the Gynecare TVT Secur™system were performed in women with stress urinary incontinence. Their mean age was 55.1 (30-76 years, meanBMI 28.5 (20.2-43.8 kg/m2. Sixty-nine implants were positioned in H-shape mode, 8 in U-shape mode. Fortyninewomen (63.6% were menopausal, 14 (18.2% previously had three or more natural deliveries, 13 (16.8%had a history of gynaecological surgeries. Thirty-one procedures were performed under general anaesthesia and46 under local anaesthesia. The mean duration of the surgery was 9 (4-42 minutes. It was possible to dischargefifty-seven (74% women on the day of the surgery. Urine retention was observed only in 1 (1.7% woman. Noother complications were recorded. Conclusions: The surgical treatment of urinary incontinence with sling procedures using the Gynecare TVTSecur™ system shows good immediate efficacy and safety. Considering this as well as the short duration ofthe procedure and its good tolerability under local anaesthesia, use

Konsensus zur Anwendung der "Tension-free Vaginal Tape" (TVT Operation bei der weiblichen Belastungsinkontinenz

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Hanzal E

2003-01-01

Full Text Available Unter der Patronanz der Medizinischen Gesellschaft für Inkontinenzhilfe Österreich wurde im Juni 2002 in Wien die 2. Auflage eines Österreichischen Tension-free Vaginal Tape (TVT Konsensus-Meetings abgehalten. TVT ist eine neue Operationstechnik zur Behandlung der weiblichen Stressharninkontinenz, die seit 1998 in Österreich eingesetzt wird. Im Rahmen des Treffens, an dem Experten aus den Fachbereichen Urologie und Gynäkologie teilnahmen, wurde die vorhandene Fachliteratur analysiert und ein Konsensus für die präoperative Abklärung, Durchführung und postoperative Verlaufskontrolle als Basis für eine laufende Qualitätsverbesserung des Verfahrens erarbeitet, dessen Ergebnis in dem vorliegenden Papier als Leitlinie zusammengefaßt ist.

The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women.

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Tincello, Douglas G; Botha, Theunis; Grier, Douglas; Jones, Peter; Subramanian, Dhinagar; Urquhart, Colin; Kirkemo, Aaron; Khandwala, Salil

2011-12-01

We examined the clinical effectiveness of a single incision sling in women with stress urinary incontinence and obtained comparative perioperative and postoperative data on retropubic and transobturator slings. Women who underwent a cough stress test were treated with surgery using a single incision, retropubic or obturator sling (Gynecare® TVT SECUR™, TVT™ or TVT Obturator System, respectively) with the choice of sling based on surgeon preference. Objective cure was assessed by the standing cough stress test at 1 year. Subjective outcomes were assessed by the Incontinence Quality of Life Questionnaire and EQ-5D™. Perioperative data and return to normal activity were recorded. Of the 1,398 women who underwent surgery there were postoperative data on 1,334, including 32.8%, 17.8% and 49.4% who received a tension free vaginal tape, obturator tension free vaginal tape and SECUR, respectively. After obturator tension free vaginal tape surgery fewer women had a positive cough stress test than after TVT and SECUR surgery (4 of 110 or 3.6% vs 24 of 187 or 12.8% and 59 of 374 or 15.8%, respectively). Incontinence Quality of Life Questionnaire effect size was 1.87, 1.42 and 1.56, respectively, indicating a large treatment effect. Using our Incontinence Quality of Life Questionnaire response definition 85.4%, 79.0% and 85.2% of the TVT, TVT outside-in obturator system and SECUR cohorts, respectively, were treatment responders (p = 0.11).The SECUR cohort had the shortest operative time, the lowest proportion of women who required an overnight stay and the most women who underwent surgery under local anesthesia. Median time to return to employment, housework, sex life and hobbies was most rapid for SECUR. This registry demonstrates the high effectiveness of all 3 approaches. The single incision sling appeared to have objective and subjective efficacy similar to that of the retropubic sling and it can be performed under local anesthesia in an office environment

Influence of TVT properties on outcomes of midurethral sling procedures

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Prien-Larsen, Jens Christian; Prien-Larsen, Thomas; Cieslak, Lars

2016-01-01

.I.F.T versus low-stiffness Intramesh L.I.F.T. tape. Our null hypothesis was that in terms of performance, SOFT tape equaled L.I.F.T. tape. METHODS: Six hundred and sixty women underwent prospective transvaginal tape (TVT) surgery for SUI: 210 had the SOFT tape placed and 450 the L.I.F.T. tape. Follow-ups were...

One-Year Surgical Outcomes and Quality of Life after Minimally Invasive Sling Procedures for the Treatment of Female Stress Urinary Incontinence: TVT SECUR® vs. CureMesh®

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Joo, Young Min; Choe, Jin Ho

2010-01-01

Purpose We compared the efficacy and safety of two minimally invasive sling procedures used to treat female stress urinary incontinence (SUI), tension-free vaginal tape (TVT) SECUR® and CureMesh®, and assessed the 1-year surgical outcomes. Materials and Methods Sixty women with SUI were assigned to undergo either the TVT SECUR (n=38) or CureMesh (n=22) procedures between April 2007 and June 2008. Patients were monitored via outpatient visits at 1 month, 3 months, and 1 year after surgery. The efficacy of these procedures was evaluated by the cough test or by a urodynamic study. At these postoperative visits, the patients also completed several questionnaires, including incontinence quality of life, patient's perception of urgency severity, the scored form of the Bristol Female Lower Urinary Tract Symptoms, visual analog scale, and questions about perceived benefit, satisfaction, and willingness to undergo the same operation again. The objective cure rate was defined as no leakage during the cough test with a full bladder. The subjective cure rate was evaluated by self-assessment of goal achievement performed 1 year postoperatively. Results The two groups were similar in preoperative characteristics and urodynamic parameters. The objective cure rates were similar between TVT SECUR and CureMesh (68.4% vs. 77.3%). All respondents reported improvement after surgery. There were no intra-operative complications. Conclusions Our results showed that the TVT SECUR and CureMesh procedures are both safe and simple to perform and have no significant differences in efficacy. Comparative studies with long-term follow-up are warranted to determine the true efficacy of these procedures. PMID:20495697

Two new mini-slings compared with transobturator tension-free vaginal tape for treatment of stress urinary incontinence: A 1-year follow-up randomized controlled trial.

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Gaber, Mohamed E; Borg, Tamer; Samour, Hazem; Nawara, Mai; Reda, Ahmed

2016-12-01

The aim of this study was to compare the outcome of two single-incision mini-slings (the Contasure-Needleless [C-NDL] and the endopelvic free anchorage) with the standard midurethral transobturator tension-free vaginal tape (TVT-O) procedure. A double blind randomized controlled study was conducted at Ain Shams University Maternity Hospital from August 2014 until July 2015. A total of 209 patients were randomized into three groups. The first group underwent the TVT-O procedure, the second group underwent the endopelvic free anchorage procedure and the third group underwent the C-NDL procedure. Patients were followed up for 12 months in terms of subjective cure, objective cure, and complications rate. After 12 months of follow-up, there were no differences among the three groups in terms of objective cure rate, subjective cure rate, patient satisfaction, or incidence of complications (de novo urge, hemorrhage, infection, and mesh erosion). The C-NDL was associated with a shorter operative time (P < 0.001) and less blood loss (P = 0.021) than the standard TVT-O. The new single-incision mini-slings showed similar efficacy and patient acceptance to that of the standard TVT-O for up to 12 months postoperatively with no difference in the complications rate. The C-NDL is associated with shorter operative time and less blood loss. © 2016 Japan Society of Obstetrics and Gynecology.

Efficacy of tension-free vaginal tape compared with transobturator tape in the treatment of stress urinary incontinence in women: analysis of learning curve, perioperative changes of voiding function

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2011-01-01

Background In this study, by comparing TVT surgery and TOT surgery for stress urinary incontinence in women, the characteristics and learning curves of both operative methods were studied. Methods A total of 83 women with stress urinary incontinence treated with tension-free vaginal tape (TVT) (n = 38) or transobturator tape (TOT) (n = 45) at Saiseikai Central Hospital between April 2004 and September 2009 were included. We compare the outcomes and learning curves between TVT surgery and TOT surgery. In statistical analysis, Student's t test, Fisher's exact test, and Mann-Whitney's U test were used. Results The surgical durations were 37.4 ± 15.7 minutes with TVT surgery and 31.0 ± 8.3 minutes with TOT surgery. A longer period of time was required for TVT surgery (p = 0.025). The residual urine at post-operative day 1 was higher in TVT surgery (25.9 ± 44.2 ml) than in TOT surgery (10.6 ± 19.2 ml) (p = 0.0452). The surgical duration of TVT surgery was shortened after the operator had performed 15 operations (p = 0.019). Conclusions In comparison of TVT surgery and TOT surgery, the surgical duration of TVT surgery was longer and the residual urine of TVT surgery was higher at post-operative day 1. Surgical experience could shorten the duration of TVT surgery. PMID:21726448

Efficacy of tension-free vaginal tape compared with transobturator tape in the treatment of stress urinary incontinence in women: analysis of learning curve, perioperative changes of voiding function

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Kanai Kunimitsu

2011-07-01

Full Text Available Abstract Background In this study, by comparing TVT surgery and TOT surgery for stress urinary incontinence in women, the characteristics and learning curves of both operative methods were studied. Methods A total of 83 women with stress urinary incontinence treated with tension-free vaginal tape (TVT (n = 38 or transobturator tape (TOT (n = 45 at Saiseikai Central Hospital between April 2004 and September 2009 were included. We compare the outcomes and learning curves between TVT surgery and TOT surgery. In statistical analysis, Student's t test, Fisher's exact test, and Mann-Whitney's U test were used. Results The surgical durations were 37.4 ± 15.7 minutes with TVT surgery and 31.0 ± 8.3 minutes with TOT surgery. A longer period of time was required for TVT surgery (p = 0.025. The residual urine at post-operative day 1 was higher in TVT surgery (25.9 ± 44.2 ml than in TOT surgery (10.6 ± 19.2 ml (p = 0.0452. The surgical duration of TVT surgery was shortened after the operator had performed 15 operations (p = 0.019. Conclusions In comparison of TVT surgery and TOT surgery, the surgical duration of TVT surgery was longer and the residual urine of TVT surgery was higher at post-operative day 1. Surgical experience could shorten the duration of TVT surgery.

Tieto- ja viestintätekniikan (TVT) infrastruktuuri ja osaaminen Saimaan ammattikorkeakoulussa vuonna 2010 : raportti muun henkilökunnan tuloksista

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Juvonen, Pasi

2011-01-01

Tässä raportissa esitetään tulokset tieto- ja viestintätekniikan (TVT) infrastruktuuri ja osaaminen -kyselystä, joka toteutettiin Saimaan ammattikorkeakoulun muulle henkilökunnalle helmikuussa 2011. Kysely toteutettiin lomakekyselynä Webropol–työkalun avulla ja siihen vastasi 49 muuhun henkilökuntaan kuuluvaa eli 43 % muusta henkilökunnasta. Kyselyssä vastaajaa pyydettiin arvioimaan omaa osaamista liittyen TVT:n käyttöön Likertin asteikolla (1-5 1 = heikko, 5 = erinomainen), sekä arvioima...

Transobturator vaginal tape in comparison to tension-free vaginal tape: A prospective trial with a minimum 12 months follow-up

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R B Nerli

2009-01-01

Full Text Available Background: The tension-free vaginal tape (TVT procedure is based on the integral theory that the midurethra has an important role in the continence mechanism. Transobturator vaginal tape (TOT is the same in concept as TVT but it differs from TVT in that, rather than passing through the retropubic space, sling materials are drawn through the obturator foramina. We prospectively compared TVT with TOT with respect to operation-related morbidity and surgical outcomes at a minimum follow up of 12 months. Materials and Methods: A total of 36 women with stress urinary incontinence (SUI were alternatively assigned to the TVT group (18 or the TOT group. Preoperative evaluation included urodynamic study and I-QOL questionnaire. One year after operation the surgical result, patient satisfaction, incontinence quality-of-life questionnaire, long-term complications, and uroflowmetry were evaluated in both groups. Results: The patient characteristics in both the TVT and TOT group were similar. Mean operating time was significantly shorter in the TOT group likened to the TVT group. Conclusions: Both the TVT and TOT procedures are minimally invasive and similar in operation-related morbidity. TOT appears to be as effective as TVT, and safer than TVT for the surgical treatment of SUI in women at 12 months follow-up.

TVT-O for the treatment of pure urodynamic stress incontinence: efficacy, adverse effects, and prognostic factors at 5-year follow-up.

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Serati, Maurizio; Bauer, Ricarda; Cornu, Jean Nicolas; Cattoni, Elena; Braga, Andrea; Siesto, Gabriele; Lizée, Daphné; Haab, François; Torella, Marco; Salvatore, Stefano

2013-05-01

Inside-out tension-free vaginal transobturator tape (TVT-O) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI), but data reporting long-term outcomes are scarce. To evaluate the efficacy and safety of TVT-O 5-yr implantation for management of pure SUI in women. A prospective observational study was conducted in four tertiary reference centers. Consecutive women presenting with urodynamically proven, pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. TVT-O implantation without any associated procedure. Data regarding subjective outcomes (International Consultation on Incontinence-Short Form [ICIQ-SF], Patient Global Impression of Improvement, patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Multivariable analyses were performed to investigate outcomes. Of the 191 women included, 21 (11.0%) had previously undergone a failed anti-incontinence surgical procedure. Six (3.1%) patients were lost to follow-up. The 5-yr subjective and objective cure rates were 90.3% and 90.8%, respectively. De novo overactive bladder (OAB) was reported by 24.3% of patients at 5-yr follow-up. Median ICIQ-SF score significantly improved from 17 (interquartile range [IQR]:16-17) preoperatively to 0 (IQR: 0-2) (pTVT-O implantation is a highly effective option for the treatment of women with pure SUI, showing a very high cure rate and a low incidence of complications after 5-yr follow-up. Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Operative shortening of the sling as a second-line treatment after TVT failure

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Matuszewski, Marcin; Michajłowski, Jerzy; Krajka, Kazimierz

2011-01-01

Introduction Stress urinary incontinence (SUI) is defined as an involuntary loss of urine during physical exertion, sneezing, coughing, laughing, or other activities that put pressure on the bladder. In some cases, recurrent or persistent SUI after sling operations may be caused by too loose placement of the sling. In the current study, we describe our method of shortening of the sling as a second-line treatment of tension-free vaginal tape (TVT) failure. Materials and methods Four women, aged 46-61, after initial TVT operation were treated for persistent SUI. The severity of SUI was estimated by: physical examinations, cough tests, 24-h pad tests, and King's Health Questionnaire. The shortening procedure, based on excising the fragment of tape and suturing it back, was performed in all patients. Results All cases achieved a good result, which was defined as restoration of full continence. No complications occurred. The 12-month follow-up showed no side-effects. The postoperative control tests: the cough and 24-h pad tests were negative in all women. The general health perceptions increased after the shortening procedure by a mean value 44.25%. The incontinence impact decreased by a mean value 44.6%. In all patients, role and physical limitations significantly decreased (by 88.5% and 80.5%, respectively). The negative emotions connected with SUI significantly decreased after the second procedure. Conclusions The operative shortening of the implanted sling is a simple, cheap, and effective method of second-line treatment in cases of TVT failure and may be offered to the majority of patients with insufficient urethral support after the first procedure. PMID:24578885

Clinical pharmacokinetics and effects of vincristine sulfate in dogs with transmissible venereal tumor (TVT).

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Hantrakul, Supannika; Klangkaew, Narumol; Kunakornsawat, Sunee; Tansatit, Tawewan; Poapolathep, Ammart; Kumagai, Susumu; Poapolathep, Saranya

2014-12-01

This study was conducted to evaluate the pharmacokinetic characteristics of vincristine and their correlation with its clinical effects in dogs with transmissible venereal tumor (TVT). Dogs with TVT were intravenously administered vincristine sulfate at a dose of 0.7 mg/m(2) of body surface area. Blood samples were collected starting from 5 min to 48 hr after drug administration. The plasma concentration of vincristine was determined using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The pharmacokinetic parameters of vincristine were characterized using a two-compartmental pharmacokinetic model. The volume of distribution, distribution half-life, elimination half-life and plasma clearance were 0.660 ± 0.210 l/kg, 21.5 ± 6.90 min, 47.6 ± 14.2 min and 0.010 ± 0.001 l/min/kg, respectively. Tumor regression was determined at weekly interval by a physical examination and histopathological analysis. In our study, three to eight administrations of vincristine at a dose of 0.7 mg/m(2) were able to induce a complete tumor regression without any evidence of gross lesion of disease. Therefore, this investigation provides the pharmacokinetic characteristics of vincristine in dogs with TVT, which may be used as an integration tool to gain a better understanding of the disposition properties of the drug and the correlation of these properties with the drug's clinical effects. In addition, we validated the LC-MS/MS method and found that it is suitable for the pharmacokinetic study of vincristine in dog plasma.

To evaluate the safety and efficacy of the TVT-Secur procedure in the treatment of stress urinary incontinence in women.

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Sandhu, J S; Karan, S C; Maiti, G D; Dudeja, Puja

2017-01-01

The prevalence of stress urinary incontinence (SUI) in the middle-aged Indian women is around 16%. The use of transvaginal tapes (TVTs) has revolutionised the surgical management of SUI. Patients who undergo placement of the tape via the transobturator route often complain of persistent thigh pain at the site of trocar insertion. The use of minimally invasive tapes with a single suburethral incision reduces surgical trauma by eliminating thigh incisions, while maintaining the cure achieved by conventional TVTs. The study was conducted to test the efficacy and safety of minimally invasive TVT-Secur tape placement for treatment of SUI in women. 20 women with stress incontinence were implanted with TVT-Secur tapes and followed up for a year. The objective cure rate of SUI was 85% at the end of a year. The improvement in the patient satisfaction and Incontinence-specific QOL scores, of both Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7), was statistically significant at 95% and 99% confidence levels. There were no complaints of thigh pain; however, there were intraoperative complications in the form of bladder perforation in 5% ( n  = 1), urethral injury in 5% ( n  = 1) and urethral tape exposure in 10% ( n  = 2), at 3 months requiring tape sectioning. These cure rates and complications are comparable to the standard TVT implantations at the end of a year, without thigh pain; however, a greater number of patients and a longer follow-up is required to see whether the long-term cure is maintained or not, before recommending the same as a standard of treatment.

Should TAVR be Performed in Nonagenarians? Insights from the STS/ACC TVT Registry

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Arsalan, Mani; Szerlip, Molly; Vemulapalli, Sreekanth; Holper, Elizabeth M.; Arnold, Suzanne V.; Li, Zhuokai; DiMaio, Michael J.; Rumsfeld, John S.; Brown, David L.; Mack, Michael J.

2017-01-01

Background Despite clinical trial evidence and clinical experience supporting the efficacy of transcatheter aortic valve replacement (TAVR), data demonstrating the benefit of TAVR specifically in the very elderly patients are limited, as they often represent only a small proportion of the clinical trial populations. Objectives To compare the outcomes of nonagenarians to younger patients undergoing TAVR in current clinical practice. Methods National U.S. data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry were analyzed. Outcomes at 30-days and 1-year were compared between patients ≥90 vs <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Results Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90. The 30-day and 1-year mortality was significantly higher among nonagenarians (≥90 vs. <90: 30-day: 8.8% vs. 5.9%, p<0.001; 1-year: 24.8% vs. 22.0%, p<0.001, absolute risk 2.8%, relative risk 12.7%). However, nonagenarians had a higher mean STS PROM score(10.9% vs. 8.1%; p<0.001) and therefore had similar ratios of observed to expected rates of 30-day death (≥90 vs. <90: 0.81, 95% CI 0.70–0.92 vs. 0.72, 95% CI 0.67–0.78). There were no differences in the rates of stroke, aortic valve reintervention or myocardial infarction at 30-days or 1-year. Nonagenarians had lower (worse) median KCCQ-12 scores at 30-days; however, there was no significant difference at 1-year. Conclusions In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality was statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in

Uroflowmetric changes, success rate and complications following Tension-free Vaginal Tape Obturator (TVT-O) operation in obese females.

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Fouad, Reham; El-Faissal, Yahia M; Hashem, Ahmed T; Gad Allah, Sherine H

2017-07-01

The goal of this study was to evaluate the outcome of Tension-free Vaginal Tape Obturator (TVT-O) operation in the treatment of urodynamic stress incontinence (USI) in obese females, with respect to uroflowmetric changes, success rate and postoperative complications. This prospective observational study included 26 patients with USI at the Obstetrics & Gynecology department-Cairo University hospital during the year 2015. The participants had body mass index (BMI)≥30. Patients underwent TVT-O operation. Follow up of the patients was performed by cough test and uroflowmetry after one week, one month, three months and six months. Postoperative complications such as groin pain, sense of incomplete emptying, need to strain to complete micturition and urinary tract infection were recorded. Comparisons between groups were done using Chi square, Phi-Cramer test for categorical variables. The mean age for the subjects was 43.58±9.01years. The mean BMI was 33.4±2.1. The success rate of TVT-O operation was 21 out of 26 patients (≈81%). Normal maximum flow rate was in 88% of patients at week one and was normal in 100% of patients at months three and six (p=0.101 & 0.101). Postoperative groin pain was the main complaint during the first week after operation and decreased significantly from week one to the 1st month postoperative (84.62% & 65.38%, P=0.041). TVT-O operation showed a high success rate in treatment of USI in obese patients without affecting the voiding function of the bladder as proven by the uroflowmetry. The main postoperative complaint was the groin pain which significantly improved after one month. Copyright © 2017 Elsevier B.V. All rights reserved.

One-year outcomes of tension-free vaginal tape (TVT) mid-urethral slings in overweight and obese women.

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Killingsworth, Lindsay B; Wheeler, Thomas L; Burgio, Kathryn L; Martirosian, Tovia E; Redden, David T; Richter, Holly E

2009-09-01

The purpose of this study was to assess the impact of body mass index (BMI) on tension-free vaginal tape (TVT) success rates, patient satisfaction, and complications 1 year following surgery. Baseline and 1-year postsurgery outcomes were abstracted, including Urogenital Distress Inventory (UDI-6) scores, Incontinence Impact Questionnaire (IIQ-7) scores, and patient satisfaction ratings. Multivariable logistic and linear regression analyses were performed to examine relationships between outcomes and BMI. Subjects (N = 195) with a mean age of 59.3 +/- 12.6 were included. There was significant improvement within each group (all p values 0.05). Differential counseling of overweight or obese women regarding outcomes of the TVT procedure is not supported by these results; longer follow-up is warranted.

Tension-Free Vaginal Tape, Transobturator Tape, and Own Modification of Transobturator Tape in the Treatment of Female Stress Urinary Incontinence: Comparative Analysis

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Marcin Zyczkowski

2014-01-01

Full Text Available Introduction. This study is a comparative evaluation of the TVT, TOT, and our own modification of TOT (mTOT in the treatment of female stress urinary incontinence from a single center experience. Material and Methods. The study was conducted on 527 patients with SUI diagnosed on the basis of urodynamic studies. They were divided into three groups—TVT: n=142, (TOT: n=129, and mTOT: n=256. All of the patients underwent evaluation at 1, 3, and 6 months after surgery. Results were statistically analysed and compared. Results. Objective and subjective effectiveness after the surgery were not significantly different in the study groups and ranged from 90.1% to 96.4%. Mean surgery time was 32.3, 28.2, and 26.4 in the TVT, TOT, and mTOT, respectively. Mean hospitalization time was 2.51 days. Mean catheter maintenance time was significantly higher in the TVT than in other groups. In the TVT group total incidence of complications was 13.4%, and it was significantly higher than that in TOT and mTOT (9.3% and 8.6%, resp.. Conclusions. TVT, TOT, and mTOT are highly effective and safe methods in the treatment of SUI. There are no differences in the efficacy between the methods with a little higher percentage of complications in the TVT group.

One Year Outcomes of Tension-Free Vaginal Tape (TVT) Mid-Urethral Slings in Overweight and Obese Women

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Killingsworth, Lindsay B.; Wheeler, Thomas L.; Burgio, Kathryn L.; Martirosian, Tovia E.; Redden, David T.; Richter, Holly E.

2011-01-01

Introduction The purpose of this study was to assess the impact of body mass index (BMI) on tension-free vaginal tape (TVT) success rates, patient satisfaction, and complications one year following surgery. Methods Baseline and one-year post-surgery outcomes were abstracted, including Urogenital Distress Inventory (UDI-6) scores, Incontinence Impact Questionnaire (IIQ-7) scores, and patient satisfaction ratings. Multivariable logistic and linear regression analyses were performed to examine relationships between outcomes and BMI. Results 195 subjects with a mean age of 59.3 ±12.6 were included. There was significant improvement within each group (all p-values 0.05) Conclusion Differential counseling of overweight or obese women regarding outcomes of the TVT procedure is not supported by these results; longer follow-up is warranted. PMID:19448965

Stress urinary incontinence in patients treated for cervical cancer: is TVT-Secur a valuable treatment option?

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Hazewinkel, Menke H.; Schilthuis, Marten S.; Roovers, Jan-Paul

2009-01-01

We present two patients with bothersome stress urinary incontinence (SUI) following radical hysterectomy and pelvic lymphadenectomy for early stage cervical cancer. One patient underwent adjuvant radiotherapy. We selected, after extensive counseling, TVT-Secur in these two patients as we aimed to

A 2 to 6 year postoperative evaluation of tension-free vaginal tape (tvt: a questionnaire based study

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Marijan Lužnik

2006-12-01

Full Text Available Background: The purpose of this article is to show the long-term subjective cure rate of urinary incontinence in patients after the tension-free vaginal tape (TVT procedure and eventual correlation of some factors with this cure rate.Methods: From December 1999 to July 2004 we performed one hundred and fifty TVT procedures at our Department of Gynecology and Obstetrics. In April 2006, a 2 to 6 year postoperatively, 149 questionnaires were sent to our patients for self-estimation of the cure rate. The subjective evaluation of results of the operation was based on definition of the improvement of continence in percents, with 13 possibilities ranging from –20 % to 100 %. With tests of correlation we wish to establish eventual connection between the cure rate of urinary incontinence and the age of women at the time of operation and the number of postoperative years. Statistical significance of eventual influence of independent variables on cure rate was analyzed using nonparametric tests in Statistical Program Package for Social Sciences (SPSS.Results: Of 119 answers, in 40 cases (33.6 % patients confirmed that they are completely healthy, and 87 women (73.1 % confirmed at least 70 % cure rate. 100 answers confirmed that 87.6 % patients had benefited by TVT procedure even 2 to 6 years postoperatively. Correlation between the long-term cure rate and the patient’s age at time of operation had Pearson’s correlation coefficient r = –0.335 and was statistically significant (p = 0.01. Statistically significantly different success was still in the groups with regard to the previous hysterectomy (p = 0.005 and the previous surgical procedure for urinary incontinence (p = 0.001. There was no statistically significant difference between the cure rate and the number of postoperative years (p = 0.236.Conclusions: 150 TVT procedures were performed very safely as solo intervention or as connected with other repair of pelvic organ prolapse at our

Insertion of the LINE-1 element in the C-MYC gene and immunoreactivity of C-MYC, p53, p21 and p27 proteins in different morphological patterns of the canine TVT

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C.R.O. Lima

2016-06-01

Full Text Available ABSTRACT The canine transmissible venereal tumor (TVT affects the external genitalia of dogs by the natural transplant of viable tumor cells. Thus, this research aimed to diagnose and characterize TVT morphological patterns, identify the insertion of the LINE-1 element in C-MYC gene, by means of the polymerase chain reaction (PCR, and evaluate the immunohistochemical expression of C-MYC, p53, p21 and p27 proteins. The relationship between C-MYC and p53 proteins and their interference on the expression of p21 and p27 were also studied. For that, 20 samples of naturally occurring TVT were used, subjected to cytopathological, histopathological and immunohistochemical analysis, and to molecular diagnosis of neoplasia. The increased tissue expression and the correlation among C-MYC, p53, p21 and p27 proteins indicate reduction and/or loss of their functionality in the TVT microenvironment, with consequent apoptotic suppression, maintenance of cell growth and progression of neoplasia.

Structural differences and architectural features of two different polypropylene slings (TVT-O and I-STOP) have no impact on biocompatibility and tissue reactions.

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Przydacz, Mikolaj; Adli, Oussama El Yazami; Mahfouz, Wally; Loutochin, Oleg; Bégin, Louis R; Corcos, Jacques

2017-06-30

To evaluate the impact of design features of the synthetic mid-urethral slings on tissue integrity and inflammatory responses. In total 30 female Sprague-Dawley rats were implanted with type I monofilamentous, macroporous polypropylene meshes: Gynecare TVT-Obturator tape ® (Ethicon Inc., Johnson & Johnson, Somerville, NJ, USA) and I-STOP ® (CL Medical Inc., Lyon, France). All animal groups were sacrificed at set time intervals - 6 weeks, 3 months, 6 months, 9 months and 12 months - and the abdominal wall was harvested with mesh strips for histological evaluation. All mesh strips appeared to be well incorporated into the abdominal wall, and no signs of shrinkage was noticed. All specimens showed a thin/delicate, loose, fibrous interface between the synthetic graft plate and abdominal wall, along with mild inflammatory reactions from 6 weeks to 12 months. Both mesh brands induced comparable, minimal foreign body reactions and integrated well into the host tissues despite differences in architectural features. TVT-O ® and I-STOP ® evoked similar low-grade inflammatory responses up to 12 months in this animal model. Structural differences and architectural features of polypropylene slings used in this study have had no impact on tissue integrity and inflammatory responses.

Comparison of Tension-free Vaginal Tape Versus Transobturator Tape in Women with Stress Urinary Incontinence

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Zinat Ghanbari

2007-06-01

Full Text Available Objective: This study compared the Tension-free vaginal tape (TVT and Transobturator tape (TOT procedures for surgical treatment of stress urinary incontinence in women.Materials and methods: This prospective non randomized clinical trial was conducted in Vali-e-asr hospital from March 2001 to March 2005. A total of 71 patients with clinical and urodynamic diagnosis of Stress urinary incontinence (SUI were enrolled in the study. Patients were divided into two groups and underwent TVT or TOT procedures. Mean operation time, cure rate, post operative urinary retention, bleeding and infection were compared between two groups. SPSS software was used for statistical analysis. Chi square and fisher exact test calculated the effects of the nominal variables. Mean difference of quantitative variables were compared by student's T- test. P ≤0.05 was considered statistically significant. Results: There was no significant difference in mean time of operation and peri-operative complications among groups. Urinary retention was 13.8% (n=5 in the TVT group versus 2.8% (n=1 in TOT group (NS. The rates of cure (91.6% vs 91.4%, improvement (5.6% vs 8.6% and failure (2.8% vs 0 were similar for the TVT and TOT groups. The rate of hemorrhagic complications was 5.5% in TVT and 2.8% in TOT group (NS.Conclusion: TOT appears to be equally efficient to TVT for surgical treatment of stress urinary incontinence after 30 months follow-up.

Effect of local infiltration analgesia on post-operative pain following TVT-O: a double-blind, placebo-controlled randomized study.

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Tommaselli, Giovanni A; Di Carlo, Costantino; Formisano, Carmen; Fabozzi, Annamaria; Nappi, Carmine

2014-08-01

To evaluate the effect of a protocol of local anesthesia and epinephrine associated with sedo-analgesia on post-TVT-O pain in comparison with infiltration of saline and epinephrine. Forty-two patients undergoing TVT-O were randomized into two groups to receive periurethral infiltration with epinephrine only (group A, n = 21) or with epinephrine plus 1 % lidocaine hydrochloride (group B, n = 21). Post-operative pain was assessed using a visual analog scale (VAS) from 0 (absence of pain) to 10 (maximum pain possible), 1, 6, 12 and 24 h after the procedure. The total amount of analgesia was recorded and the proportion of women reporting a pain VAS score ≥4, 1 h after the procedure was calculated. ANOVA for repeated measures and Bonferroni correction, the Student's t test for independent samples, the Mann-Whitney U test, the Fisher exact test, or the χ (2) test for parametric was used. Pain level was significantly lower in group B 1 (p = 0.01) and 6 h (p = 0.05) after surgery, but not 12 and 24 h after the procedure. No significant difference was observed in the proportion of women requesting analgesia and in the total dosage of analgesics between the two groups. A significant higher proportion of women in group A reported a pain VAS score higher than four 1 h after surgery in comparison with patients in group B. This randomized study seems to indicate that systematic infiltration before TVT-O positioning with local anesthetic may reduce immediate post-operative pain.

Siebenjährige Follow-up-Studie zur Anwendung des spannungsfreien Vaginalbandes (TVT zur Behandlung der Stressharninkontinenz

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Nilsson CG

2005-01-01

Full Text Available Studienzweck: Evaluierung der langfristigen Heilungs- und Spätkomplikationsraten bei Stressharninkontinenz der Frau bei Behandlung mit dem spannungsfreien Vaginalband (TVT, das anhand einer minimal-invasiven Operation eingesetzt wird. Methodik: In drei Studienzentren durchgeführte prospektive Beobachtungs- und Kohortenstudie mit ursprünglich 90 Frauen, deren primäre Stressharninkontinenz einen operativen Eingriff erforderlich machte. Zu den Bewertungsvariablen gehörten ein Vorlagentest (Pad-Test zur Messung des Uringewichts je 24 Stunden, ein Stresstest, eine visuelle Analogskala (VAS zur Beurteilung des Beschwerdegrads sowie ein Fragebogen zur Beurteilung der subjektiven Wahrnehmung des Kontinenzstatus durch die Frauen. Ergebnisse: Als Follow-up-Zeitraum wurde ein durchschnittlicher Zeitraum von 91 Monaten (78–100 Monate festgelegt. Sowohl die objektive als auch die subjektive Heilungsrate lag bei den an der Follow-up-Studie teilnehmenden 80 Frauen bei 81,3 %. Bei 7,8 % der Frauen wurde ein asymptomatischer Prolaps der Organe des kleinen Beckens, bei 6,3 % De-novo-Drangsymptome und bei 7,5 % eine rezidivierende Harnwegsinfektion festgestellt. Weitere unerwünschte Nebenwirkungen des Verfahrens wurden nicht festgestellt. Schlussfolgerung: Die Wirkung der TVT-Operation zur Behandlung der Stressharninkontinenz der Frau bleibt über einen Zeitraum von 7 Jahren erhalten.

Outcomes for the Commercial Use of Self-Expanding Prostheses in Transcatheter Aortic Valve Replacement: A Report From the STS/ACC TVT Registry.

Science.gov (United States)

Sorajja, Paul; Kodali, Susheel; Reardon, Michael J; Szeto, Wilson Y; Chetcuti, Stanley J; Hermiller, James; Chenoweth, Sharla; Adams, David H; Popma, Jeffrey J

2017-10-23

The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry. TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed. Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined. Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03). Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

HYPER-­TVT: Development and Implementation of an Interactive Learning Environment for Students of Chemical and Process Engineering

Science.gov (United States)

Santoro, Marina; Mazzotti, Marco

2006-01-01

Hyper-TVT is a computer-aided education system that has been developed at the Institute of Process Engineering at the ETH Zurich. The aim was to create an interactive learning environment for chemical and process engineering students. The topics covered are the most important multistage separation processes, i.e. fundamentals of separation…

Tape functionality: position, change in shape, and outcome after TVT procedure--mid-term results.

Science.gov (United States)

Kociszewski, Jacek; Rautenberg, Oliver; Kolben, Sebastian; Eberhard, Jakob; Hilgers, Reinhard; Viereck, Volker

2010-07-01

This study evaluates the relevance of the tape position and change in shape (tape functionality) under in vivo conditions for mid-term outcome. Changes in the sonographic tension-free vaginal tape (TVT) position relative to the percentage urethral length and the tape-urethra distance were determined after 6 and 48 months in 41 women with stress urinary incontinence. At 48 months, 76% (31/41) of women were cured, 17% (7/41) were improved, and 7% (3/41) were failures. Disturbed bladder voiding was present in 12% (5/41), de novo urge incontinence in 7% (3/41). The median TVT position was at 63% of urethral length. Median tape-urethra distance was 2.7 mm, ranging from 2.9 mm in continent patients without complications to 1.1 mm in those with obstructive complications. Patients with postoperative urine loss had a median distance of 3.9 mm. The tape was stretched at rest and C-shaped during straining in 15 of 41 women (37%) at 48 months (all continent). Patients with this tape functionality at 6 months were also cured at 48 months in 86% of cases (19/22), and only 14% (3/22) showed recurrent incontinence. Mid-term data suggest an optimal outcome if the tape is positioned at least 2 mm from the urethra at the junction of the middle and distal thirds. Patients with optimal tape functionality at 6 months are likely to show mid-term therapeutic success.

Thermal-to-visible transducer (TVT) for thermal-IR imaging

Science.gov (United States)

Flusberg, Allen; Swartz, Stephen; Huff, Michael; Gross, Steven

2008-04-01

We have been developing a novel thermal-to-visible transducer (TVT), an uncooled thermal-IR imager that is based on a Fabry-Perot Interferometer (FPI). The FPI-based IR imager can convert a thermal-IR image to a video electronic image. IR radiation that is emitted by an object in the scene is imaged onto an IR-absorbing material that is located within an FPI. Temperature variations generated by the spatial variations in the IR image intensity cause variations in optical thickness, modulating the reflectivity seen by a probe laser beam. The reflected probe is imaged onto a visible array, producing a visible image of the IR scene. This technology can provide low-cost IR cameras with excellent sensitivity, low power consumption, and the potential for self-registered fusion of thermal-IR and visible images. We will describe characteristics of requisite pixelated arrays that we have fabricated.

Is there a learning curve for the TVT-O procedure? A prospective single-surgeon study of 372 consecutive cases.

Science.gov (United States)

Serati, Maurizio; Bogani, Giorgio; Braga, Andrea; Sorice, Paola; Salvatore, Stefano; Uccella, Stefano; Ghezzi, Fabio

2015-03-01

To evaluate for the first time in the literature the learning curve of Inside-out transobturator tape (TVT-O™). A prospective observational study was conducted in a tertiary reference center. Consecutive women treated by TVT-O™ performed by one surgeon were included. Data regarding subjective, objective cure rates, and adverse events were collected. Trends, over the number of procedures, were estimated using assay analyses. Number of procedures and variables were interpolating in standard curves using linear lines. Three hundred and seventy two procedures were included. Postoperative pain levels decreased with the increase in the level of expertise (pain levels: 1-day: from 6.6 (±3.3) to 4.3 (±3.1); 95%CI: -0.01603 to 0.001235, p=0.04; 2-day: from 5.6 (±4.1) to 3.6 (±3.7); 95%CI: -0.02092 to -0.002497, p=0.01; 12-month: from 0.1 (±0.7) to 0 (±0); 95%CI: -0.001814 to 0.05019, p=0.07). Overall, objective cure rate was achieved in 93.5% of patients. Additionally, 88.2% and 88.7% patients reported "much better" feeling at PGI-I scale and 80% reduction in UDI score, respectively. We observed, that delta ICIQ-sf (from 12 (±8.7) to 14 (±6.0); p=0.04) and delta-UDI (from 91% to 97%; p=0.04) improved over the time. TVT-O procedure offers excellent outcomes with high objective and subjective cure rates and low complications rate, even at the beginning of the surgeon's learning curve. However, a high experience of the surgeon could significantly improve the subjective cure rate and could reduce postoperative the groin pain. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Comparability of prostate trials

DEFF Research Database (Denmark)

Suciu, S; Sylvester, R; Iversen, P

1993-01-01

The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity....... In order to overcome these various types of heterogeneity and to compare like with like, the treatment comparison should be stratified a posteriori by question (i.e., type of castration or type of anti-androgen studied) and by study. In this way, one may draw valid conclusions. Of course, those trials...

A Retrospective Study Comparing Tension-free Vaginal Tape and Transobturator Suburethral Tape for Surgical Treatment of Female Stress Urinary Incontinence — A Preliminary Report

Directory of Open Access Journals (Sweden)

Ching-Hwa Yang

2007-12-01

Conclusion: There appears to be equal efficacy between TVT and TVT-O for the surgical treatment of female SUI, but operative time was significantly shorter in the TVT-O group because intraoperative cystoscopic check-up is not required.

TVT-Qualitätskontrolle der gynäkologischen Abteilung des Krankenhauses der Barmherzigen Brüder Graz

Directory of Open Access Journals (Sweden)

Gruber-Fröhlich E

2006-01-01

Full Text Available Seit Einführung der TVT-Operation an unserer Abteilung im Jahre 1999 führten wir eine sorgfältige Patientenselektion und ein Follow-up durch. Unserer Meinung nach ist eine solche Vorgangsweise nicht nur nützlich, um die Technik aller Operateure laufend zu verbessern, sondern auch um spezielle Problemfälle herauszufiltern. Die hypotone Urethra und Fälle mit Mischinkontinenz haben sich dabei in unserer Studie als Problemkonstellationen herausgestellt. Unsere Ergebnisse sind mit denen der skandinavischen Studie vergleichbar.

Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

NARCIS (Netherlands)

Wieringa, NF; Vos, R; de Graeff, PA

Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

Effectiveness of Retropubic Tension-Free Vaginal Tape and Transobturator Inside-Out Tape Procedures in Women With Overactive Bladder and Stress Urinary Incontinence

Directory of Open Access Journals (Sweden)

Ji-Yeon Han

2013-09-01

Full Text Available Purpose We compared the effectiveness of the retropubic tension-free vaginal tape (TVT and the transobturator inside-out tape (TVT-O in treating symptoms of overactive bladder (OAB in women with stress urinary incontinence (SUI. Methods Women with urodynamic SUI and OAB (mean urgency episodes ≥1 and frequency ≥8/24 hours on a 3-day voiding diary were assigned to the TVT or TVT-O group. Preoperative measures were based on a urodynamic study, 3-day voiding diary, the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTSSF, and the urgency perception scale (UPS. At 12 postoperative months, the 3-day voiding diary, symptoms questionnaire, patient satisfaction, and standing stress test were assessed. The primary endpoint was change in the number of urgency episodes/24 hours from baseline to 12 months. Results In this group of 132 women, 42 received TVT and 90 received TVT-O. The mean urgency episodes/24 hours decreased from 6.3±5.5 to 1.6±3.2 in the TVT group and from 5.1±4.4 to 1.8±3.0 in the TVT-O group. The mean percent change was significantly greater after TVT than after TVT-O (73% vs. 60%, P=0.049. All subscales of BFLUTSSF and UPS were significantly improved using either method, with significantly greater improvement seen in the quality of life (QoL domain after TVT (P=0.002. There were no significant differences in the cure and satisfaction rates between the two groups. Conclusions Intervention with the TVT or the TVT-O significantly improved symptoms of OAB in women with SUI and OAB. Urgency and QoL significantly improved after TVT compared with that after TVT-O.

Effectiveness of Retropubic Tension-Free Vaginal Tape and Transobturator Inside-Out Tape Procedures in Women With Overactive Bladder and Stress Urinary Incontinence

Science.gov (United States)

Han, Ji-Yeon; Choo, Myung-Soo; Lee, Young-Suk; Seo, Ju Tae; Kim, Jang Hwan; Kim, Young Ho

2013-01-01

Purpose We compared the effectiveness of the retropubic tension-free vaginal tape (TVT) and the transobturator inside-out tape (TVT-O) in treating symptoms of overactive bladder (OAB) in women with stress urinary incontinence (SUI). Methods Women with urodynamic SUI and OAB (mean urgency episodes ≥1 and frequency ≥8/24 hours on a 3-day voiding diary) were assigned to the TVT or TVT-O group. Preoperative measures were based on a urodynamic study, 3-day voiding diary, the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTSSF), and the urgency perception scale (UPS). At 12 postoperative months, the 3-day voiding diary, symptoms questionnaire, patient satisfaction, and standing stress test were assessed. The primary endpoint was change in the number of urgency episodes/24 hours from baseline to 12 months. Results In this group of 132 women, 42 received TVT and 90 received TVT-O. The mean urgency episodes/24 hours decreased from 6.3±5.5 to 1.6±3.2 in the TVT group and from 5.1±4.4 to 1.8±3.0 in the TVT-O group. The mean percent change was significantly greater after TVT than after TVT-O (73% vs. 60%, P=0.049). All subscales of BFLUTSSF and UPS were significantly improved using either method, with significantly greater improvement seen in the quality of life (QoL) domain after TVT (P=0.002). There were no significant differences in the cure and satisfaction rates between the two groups. Conclusions Intervention with the TVT or the TVT-O significantly improved symptoms of OAB in women with SUI and OAB. Urgency and QoL significantly improved after TVT compared with that after TVT-O. PMID:24143294

Patient goals after tension free vaginal tape operation

DEFF Research Database (Denmark)

Glavind, Karin; Bjørk, Jonna; Kousgaard, Sabrina Just

INTRODUCTION: This prospective study investigates sexual function in women after a tension-free vaginal tape (TVT) operation and compares short-term and long-term effects. METHODS: Sixty-three women had a TVT operation performed at Aalborg University Hospital, Department of Gynecology and Obstetr......INTRODUCTION: This prospective study investigates sexual function in women after a tension-free vaginal tape (TVT) operation and compares short-term and long-term effects. METHODS: Sixty-three women had a TVT operation performed at Aalborg University Hospital, Department of Gynecology...

TVT for the treatment of urodynamic stress incontinence: Efficacy and adverse effects at 13-year follow-up.

Science.gov (United States)

Serati, Maurizio; Sorice, Paola; Bogani, Giorgio; Braga, Andrea; Cantaluppi, Simona; Uccella, Stefano; Caccia, Giorgio; Salvatore, Stefano; Ghezzi, Fabio

2017-01-01

To assess long-term subjective, objective, and urodynamic outcomes of retropubic mid-urethral slings at 13-year follow-up. This was a prospective observational study. Consecutive women with proven urodynamic stress incontinence were treated with standard retropubic tension free vaginal tape (TVT). Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. All the included patients underwent preoperative clinical and urodynamic evaluations. During follow-up examinations, women were assessed for subjective satisfaction and objective cure rates. The Cox model was used in order to investigate factors predicting the risk of recurrent stress urinary incontinence (SUI), over the study period. Overall, 55 patients were suitable for the analysis. At 13-year follow-up, 47 out of 55 (85.5%) patients declared themselves cured (p-for-trend 0.02) and 48 out of 58 (87.2%) were at least improved (p-for-trend 0.07). No significant deterioration of objective cure rates was observed over time (P = 0.29). At the time of the last evaluation, 50 out of 55 (90.9%) women were objectively cured; urodynamic evaluation confirmed this finding in 49 (89.1%) patients. Considering factors predictive of SUI recurrence, we observed that, via multivariate analysis, obesity (HR 7.2; P = 0.01) and maximum detrusor pressure during the voiding phase ≤29 cmH 2 O (HR 8.0; P = 0.01) were the only independent predictors of recurrent SUI. Our data confirmed that TVT is a highly effective and safe procedure also at 13-year follow-up. Interestingly, we observed a significant decrease of subjective satisfaction over time. Neurourol. Urodynam. 36:192-197, 2017. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Production controls (PC) and technical verification testing (TVT). A methodology for the control and tracking of LILW waste package conditioning

International Nuclear Information System (INIS)

Leon, A.M.; Nieto, J.L.L.; Garrido, J.G.

2003-01-01

As part of its low and intermediate level radioactive waste (LILW) characterisation and acceptance activities, ENRESA has set up a quality control programme that covers the different phases of radioactive waste package production and implies different levels of tracking in generation, assessment of activity and control of the documentation associated therewith. Furthermore, ENRESA has made available the mechanisms required for verification, depending on the results of periodic sampling, of the quality of the end product delivered by the waste producers. Both processes are included within the framework of two programmes of complementary activities: production controls (PC) and technical verification testing (TVT). (orig.)

Mid-urethral slings in female incontinence: Current status

Directory of Open Access Journals (Sweden)

Ryan M Krlin

2011-01-01

Full Text Available The advent of the mid-urethral sling (MUS 15 years ago has drastically changed the surgical management of stress urinary incontinence (SUI. Both retropubic and transobturator MUS can be placed in the ambulatory setting with excellent results. The tension-free vaginal tape (TVT sling has the most robust and long-term data, but more recent literature suggests that the transobturator tape sling may offer comparable efficacy in appropriately selected patients. Single incision sling (SIS is the newest addition to the MUS group and was developed in an attempt to minimize morbidity and create an anti-incontinence procedure that could be performed in the office. The efficacy of SIS remains unknown as the current literature regarding SIS lacks long-term results and comparative trials. The suprapubic arc sling appears to have equally effective outcomes in at least the short-term when compared with TVT. Although evolution of the SIS has led to a less invasive procedure with decreased post-op pain and reduced recovery time, durability of efficacy could be the endpoint we are sacrificing. Until longer-term data and more quality comparison trials are available, tailoring one′s choice of MUS to the individual patient and her unique clinical parameters remains the best option.

Comparison of Midterm Efficiency and Complications of Tension-Free Vaginal Tape Alone and Tension-Free Vaginal Tape Performed with Vaginal Hysterectomy

Directory of Open Access Journals (Sweden)

Emre Sinan Güngör

2017-09-01

Full Text Available Aim: To evaluate and compare the results and complications of tension-free vaginal tape (TVT when performed alone or with vaginal hysterectomy (VH and to evaluate the mid-term success rates of TVT for both groups. Methods: A retrospective study was performed on 179 patients who had TVT alone for stress urinary incontinance (SUI or TVT with VH for SUI and vaginal prolapse. Demographic, outcome and complication data were obtained from medical records. The main outcome measures were postoperative SUI and voiding dysfunction. Results: The mean age of the patients who underwent TVT and TVT+VH were 50.2±6.8 and 52.2±8.1, respectively (p>0.05 and the mean parity was 4±2.07 and 4.15±2.02, respectively (p>0.05. The success rate was significantly higher in TVT alone group than in TVT+VH group (93.6% vs. 84.5%, p0.05. Overall complication rate was higher in TVT+VH group (4.2% vs. 9.5%, p<0.05. Postoperative residuel urine volumes were significantly higher than preoperative residuel urine volumes in both groups (p=0.001. Due to mesh rejection, second surgery was performed in one patient from both groups to reomove the mesh. Conclusion: Midterm success rates were significantly higher in TVT group than in TVT+VH group, but success rates in TVT+VH were acceptable. Overall complication rates were higher in TVT+VH group; requirement for a second surgery was similar for both groups.

Comparative evaluation of hmopolesis and serum proteins from dogs with transmissible venereal tumor by natural ocorrence and induced by alogenic transplant

International Nuclear Information System (INIS)

Aptekmann, K.P.; Costa, M.T.; Fabeni, R. de C.; Santana, A.E.

2005-01-01

The objective of this study was to evaluate the haemopoiesis and total serum proteins of dogs with canine Transmissible Venereal Tumour (TVT) (naturally occurring or induced by allogenic transplant). Complete haemogram, bone marrow evaluation, total serum protein, albumin determination and electrophoretic fractionation of serum proteins were performed. Results revealed normocytic normochromic anaemia and thrombocytopenia in dogs with naturally occurring TVT

Řešení přetrvávající stresové inkontinence moči u žen po neúspěšné operaci TVT-SECUR*

Czech Academy of Sciences Publication Activity Database

Martan, A.; Švabík, K.; Mašata, J.; Koleška, T.; Haddad El, R.; Pavlíková, Markéta

2009-01-01

Roč. 74, č. 1 (2009), s. 3-7 ISSN 1210-7832 Grant - others:GA MZd(CZ) NR9216 Institutional research plan: CEZ:AV0Z10300504 Keywords : inkontinence moči u žen * komplikace * TVT-S * transperineální ultrazvukové vyšetření Subject RIV: BB - Applied Statistics, Operational Research

Comparability of prostate trials

DEFF Research Database (Denmark)

Suciu, S; Sylvester, R; Iversen, P

1993-01-01

The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

Creating a gold standard surgical device: scientific discoveries leading to TVT and beyond: Ulf Ulmsten Memorial Lecture 2014.

Science.gov (United States)

Petros, Peter

2015-04-01

The discovery of tension-free vaginal tape (TVT) began in 1986 with two unrelated observations: pressure applied unilaterally at the midurethra controlled urine loss on coughing; implanted Teflon tape caused a collagenous tissue reaction. In 1987, Mersilene tape was implanted retropubically in 13 large dogs, with the aim of creating an artificial collagenous pubourethral neoligament. Extensive testing showed that the operation was safe and effective. In 1988-1989, human testing was carried out (n = 30). Mersilene tape cured 100 % of stress and mixed incontinence with a sling in situ; however, there was simultaneous recurrence of the two symptoms in 50 % on sling removal. X-rays showed no elevation of the bladder neck. In 1990-1993, collaboration with Ulf Ulmsten took place: a permanently implanted tape was required. Polypropylene was the ideal material. In 2003, the neoligament principle was applied as an adjustable "micro" sling to the arcus tendineus fasciae pelvis (ATFP), cardinal, uterosacral ligaments, and perineal body for cure of cystocele, rectocele, and apical prolapse. It was found that symptoms such as urgency, nocturia, chronic pelvic pain, obstructive defecation syndrome (ODS), and fecal incontinence were frequently cured or improved. The lecture concluded with advice to younger members. Without new paradigms, there are no randomized controlled trials, no meta-analyses, Cochrane. Indeed, no progress. Be open to new concepts. Read Kuhn's "The Structure of Scientific Revolutions" to understand the discovery process. Examine the relationship among symptoms, ATFP, cardinal, uterosacral ligaments, and the perineal body. This is the next paradigm. Don't disregard anomalies. Pursue them. They are the pathway to discovery. Innovation is born from challenge, not conformity. Persist, even when meeting resistance. Resistance is a sign that your discovery is important.

The efficacy of maggot debridement therapy - a review of comparative clinical trials

DEFF Research Database (Denmark)

Zarchi, K.; Jemec, G.B.

2012-01-01

in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia......, including hydrocolloid, hydrogel and saline moistened gauze. However, the design of the studies was suboptimal, with important differences in the use of other therapies, such as compression, that may influence both debridement and healing between the compared groups, as well as inappropriately short follow...

Influence of TVT properties on outcomes of midurethral sling procedures: high-stiffness versus low-stiffness tape.

Science.gov (United States)

Prien-Larsen, Jens Christian; Prien-Larsen, Thomas; Cieslak, Lars; Dessau, Ram B

2016-07-01

Although there is clear consensus on the use of monofilament polypropylene tapes for treating stress urinary incontinence (SUI), tapes differ in weight, stiffness, and elasticity. In this study, we compared outcomes of two tape types: high-stiffness Intramesh SOFT L.I.F.T versus low-stiffness Intramesh L.I.F.T. tape. Our null hypothesis was that in terms of performance, SOFT tape equaled L.I.F.T. tape. Six hundred and sixty women underwent prospective transvaginal tape (TVT) surgery for SUI: 210 had the SOFT tape placed and 450 the L.I.F.T. tape. Follow-ups were scheduled at 3 and 12 months. Objective cure at 3-months' follow-up was 87 % in the SOFT group vs 94 % in the L.I.F.T. group (p = 0.003) and at 12 months 86 vs 96 % (p = 0.0004), respectively. Subjective outcomes were equal. For SOFT tape, the objective failure rate at 3 months was especially pronounced in women older than 70 years: 31 vs 10 % (p = 0.008), and subjective failure was 24 vs 7 % (p = 0.01). At 12 months, objective failure for the SOFT tape was significantly higher in both age groups compared with L.I.F.T. [odds ratio (OR) 2.17]. Multivariate analysis showed that body mass index (BMI) ≥30 (OR 2.41), mixed incontinence (MUI) (OR 2.24), use of SOFT tape (OR 2.17), and age ≥ 70 years are significant independent risk factors for surgical failure. Outcomes with SOFT tape are significantly inferior than with L.I.F.T. tape, especially among elderly women. Therefore, the two variants of monofilament polypropylene tape are not interchangeable.

Clinical Trial Of Glimepiride Compared With Glibenclamide For ...

African Journals Online (AJOL)

Objective: The study was undertaken to compare the efficacy and safety of Glimepiride against Glibenclamide in the management of patients with type 2 DM in Jos, Nigeria. Study design: An open, randomised controlled trial. Setting: Diabetes Clinic of the Jos University Teaching Hospital, Jos, Nigeria. Subjects: Seventy four ...

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

African Journals Online (AJOL)

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

The decision to conduct a head-to-head comparative trial: a game-theoretic analysis.

Science.gov (United States)

Mansley, Edward C; Elbasha, Elamin H; Teutsch, Steven M; Berger, Marc L

2007-01-01

Recent Medicare legislation calls on the Agency for Healthcare Research and Quality to conduct research related to the comparative effectiveness of health care items and services, including prescription drugs. This reinforces earlier calls for head-to-head comparative trials of clinically relevant treatment alternatives. Using a game-theoretic model, the authors explore the decision of pharmaceutical companies to conduct such trials. The model suggests that an important factor affecting this decision is the potential loss in market share and profits following a result of inferiority or comparability. This hidden cost is higher for the market leader than the market follower, making it less likely that the leader will choose to conduct a trial. The model also suggests that in a full-information environment, it will never be the case that both firms choose to conduct such a trial. Furthermore, if market shares and the probability of proving superiority are similar for both firms, it is quite possible that neither firm will choose to conduct a trial. Finally, the results indicate that incentives that offset the direct cost of a trial can prevent a no-trial equilibrium, even when both firms face the possibility of an inferior outcome.

Quality of Life Outcomes after Transcatheter Aortic Valve Replacement in an Unselected Population. A Report from the STS/ACC TVT Registry™

Science.gov (United States)

Arnold, Suzanne V.; Spertus, John A.; Vemulapalli, Sreekanth; Li, Zhuokai; Matsouaka, Roland A.; Baron, Suzanne J.; Vora, Amit N.; Mack, Michael J.; Reynolds, Matthew R.; Rumsfeld, John S.; Cohen, David J.

2017-01-01

Importance In clinical trials, transcatheter aortic valve replacement (TAVR) has been shown to improve symptoms and quality of life. As this technology moves into general clinical practice, it is critical to evaluate the health status outcomes among unselected patients treated with TAVR. Design/Participants Observational study of patients with severe aortic stenosis treated with TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry. Main Outcomes Disease-specific health status was assessed at baseline and at 30 days (n=31,636) and 1 year after TAVR (n=7,014) with the Kansas City Cardiomyopathy Questionnaire-overall summary score (KCCQ-OS; range 0–100 points). We examined factors associated with health status at 1 year after TAVR using multivariable linear regression, with adjustment for baseline health status and accounting for clustering of patients within sites. Results Mean baseline KCCQ-OS was 42.3±23.7, indicating substantial health status impairment. Surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year, with a mean improvement in the KCCQ-OS of 27.6 points at 30 days and 31.9 points at 1 year. Worse baseline health status, older age, higher ejection fraction, lung disease, home oxygen, lower mean aortic valve gradient, prior stroke, diabetes, pacemaker, atrial fibrillation, slower gait speed, and non-femoral access were associated with worse health status at 1 year. Overall, 62.3% of patients had a favorable outcome at 1 year (alive with reasonable quality of life [KCCQ-OS ≥60] and no significant decline [≥10 points] from baseline) with the lowest rates seen among patients with severe lung disease (51.4%), on dialysis (47.7%), or with very poor baseline health status (49.2%). Conclusion In a national, contemporary clinical practice cohort of unselected patients, we found that improvement in health status following TAVR was similar to that

Urininkontinenskirurgi i Danmark 2001-2003

DEFF Research Database (Denmark)

Ammendrup, Astrid Cecilie; Bendixen, Anette; Sander, Pia

2009-01-01

of postoperative complications was 33.9% after an abdominal procedure, 10.8% after a Tension free Vaginal Tape (TVT) like procedure and 2.3% after urethral injection therapy. For abdominal procedures, "high volume" departments (> 45 operations/3 years) had significantly fewer complications compared to "low volume......" departments (TVT-like group. Registration of complications and reoperations was incomplete and incorrect, especially in the TVT-like group. Mortality within 30 days was 0. CONCLUSION: This study shows a decentralised organisation of surgical...... incontinence activity in Denmark. Many departments carried out very few operations. There is a need for better registration, especially of TVT slings, and there is a need to reliably monitor the quality of incontinence surgery in Denmark. Surgical incontinence activity should be more centralised...

A socio-ecological approach promoting physical activity and limiting sedentary behavior in adolescence showed weight benefits maintained 2.5 years after intervention cessation.

Science.gov (United States)

Simon, C; Kellou, N; Dugas, J; Platat, C; Copin, N; Schweitzer, B; Hausser, F; Bergouignan, A; Lefai, E; Blanc, S

2014-07-01

Obesity in youth remains a major public health issue. Yet no effective long-term preventive strategy exists. We previously showed that a school-based socio-ecological approach targeting behavior and social/environmental influences on physical activity (PA) prevented 4-year excessive weight gain in 12-year olds. In this study, we investigated if this efficacy persists 30 months after intervention cessation. The program targeted students, family, school and the living environment to promote/support PA and prevent sedentary behavior (SB). A total of 732 students from eight randomized middle schools completed the 4-year trial. At the 30-month post-trial follow-up, body mass index (BMI), fat mass index (FMI), leisure PA (LPA), home/school/workplace active commuting, TV/video time (TVT), and attitudes toward PA were measured in 531 adolescents. The beneficial effects of the intervention on the excess BMI increase (+0.01 vs +0.34 kg m(-2) in the intervention and control groups, respectively) and on the overweight incidence in initially non-overweight students (4.3% vs 8.6%; odds ratio=0.48 (95% confidence interval: 0.23-1.01)) were maintained at the post-trial follow-up. LPA was not maintained at the level achieved during the trial. However, we still observed a prevention of the age-related decrease of the adolescents' percentage reporting regular LPA (-14.4% vs -26.5%) and a higher intention to exercise in the intervention group. The intervention promoted lower TVT (-14.0 vs +13.6 min per day) and higher active commuting changes (+11.7% vs -4.8%). Trends in higher BMI reduction in students with high initial TVT and in the least wealthy group were noted. TVT changes throughout the follow-up predicted excess BMI and FMI changes. Long-term multilevel approach targeting PA and SB prevents excessive weight gain up to 30 months after intervention cessation. The efficacy may be higher in the most sedentary and least wealthy adolescents. Healthy PA-related behavior

Towards patient centered care in female stress urinary incontinence

NARCIS (Netherlands)

Labrie, J.

2015-01-01

This thesis focussed on the treatment of stress urinary incontinence in women. It comprises the results of the PORTRET study (Physiotherapy OR Tvt Effectiveness Trial). Currently, pelvic floor muscle training is advised as initial treatment for all women with stress urinary incontinence. We

HISTOPATHOLOGICAL AND CYTOLOGICAL ANALYSIS OF TRANSMISSIBLE VENEREAL TUMOR IN DOGS AFTER TWO TREATMENT PROTOCOLS

Directory of Open Access Journals (Sweden)

Fabiana Aguena Sales Lapa

2012-06-01

Full Text Available The transmissible venereal tumor (TVT is a contagious neoplasm of round cells that frequently affect dogs. The treatment consists of chemotherapy being more effective the vincristine alone, however the resistance emergence to this agent due multidrug resistance of the P-glycoprotein (P-gp, a transporter protein encoded by the MDR1 gene, has been taking the association with other drugs. Recent studies demonstrated the antitumoral effect of the avermectins when associated to the vincristine in the treatment of some neoplasms. Therefore, the objective of the present study was to compare the effectiveness of standard treatment of TVT with vincristine only when compared to combined treatment with vincristine and ivermectin, evaluated through number of applications of the two protocols, histopathological and cytological analysis from 50 dogs diagnosed with TVT during the period of 2007 to 2010. The combined protocol significant reduced the number of applications and cytological and histopathological findings collaborate with the hypothesis that the combination of vincristine and ivermectin promotes faster healing than the use of vincristine alone. Combination treatment with vincristine and ivermectin could be in the future an excellent therapeutic alternative for the treatment of TVT for probably reducing the resistance to vincristine, simultaneously reducing the cost of TVT treatment and promoting a faster recovery of the dog.

The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

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Thomas Peter

2011-07-01

Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

Terror attacks increases the risk of vascular injuries

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Eitan eHeldenberg

2014-05-01

Full Text Available Objectives: Extensive literature exists about military trauma as opposed to the very limited literature regarding terror-related civilian trauma. However, terror-related vascular trauma (VT, as a unique type of injury, is yet to be addressed.Methods: A retrospective analysis of the Israeli National Trauma Registry was performed. All patients in the registry from 09/2000 to 12/2005 were included. The subgroup of patients with documented vascular trauma (VT (N=1,545 was analyzedand further subdivided into those suffering from Terror-related Vascular Trauma (TVT and Non-Terror related Vascular Trauma (NTVT. Both groups were analyzed according to mechanism of trauma, type and severity of injury and treatment.Results: Out of 2,446 terror related trauma admissions 243 sustained TVT (9.9% compared to 1302 VT patients from Non Terror trauma (1.1%. TVT injuries tend to be more complex and most patients were operated on. ICU admissions and hospitallength of stay was higher in the TVT group. Penetrating trauma was the prominent cause of injury among the TVT group. TVT group had a higher proportion of patients with severe injuries (ISS>16 and mortality. Thorax injuries were more frequent in the TVT group. Extremity injuries were the most prevalent vascular injuries in both groups; however NTVT group had more upper extremity injuries, while the TVT group had significantly more lower extremity injuries.Conclusion: Vascular injuries are remarkably more common among terror attack victims than among non-terror trauma victims and the injuries of terror casualties tend to be more complex. The presence of a vascular surgeon will ensure a comprehensive clinical care.

Decision on performing interim analysis for comparative clinical trials.

Science.gov (United States)

Pak, Kyongsun; Jacobus, Susanna; Uno, Hajime

2017-09-01

In randomized-controlled trials, interim analyses are often planned for possible early trial termination to claim superiority or futility of a new therapy. While unblinding is necessary to conduct the formal interim analysis in blinded studies, blinded data also have information about the potential treatment difference between the groups. We developed a blinded data monitoring tool that enables investigators to predict whether they observe such an unblinded interim analysis results that supports early termination of the trial. Investigators may skip some of the planned interim analyses if an early termination is unlikely. We specifically focused on blinded, randomized-controlled studies to compare binary endpoints of a new treatment with a control. Assuming one interim analysis is planned for early termination for superiority or futility, we conducted extensive simulation studies to assess the impact of the implementation of our tool on the size, power, expected number of interim analyses, and bias in the treatment effect. The numerical study showed the proposed monitoring tool does not affect size or power, but dramatically reduces the expected number of interim analyses when the effect of the treatment difference is small. The tool serves as a useful reference when interpreting the summary of the blinded data throughout the course of the trial, without losing integrity of the study. This tool could potentially save the study resources and budget by avoiding unnecessary interim analyses.

An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

NARCIS (Netherlands)

M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); F.J.J. van de Werf (Frans); P.W. Armstrong (Paul); P.E. Aylward (Philip Edmund); G.I. Barbash; E.R. Bates (Eric); A. Betriu; J.H. Chesebro (James); J.J. Col (Jacques); D.P. de Bono (David); J.M. Gore (Joel); A.D. Guerci (Alan); J.R. Hampton (John)

1993-01-01

textabstractBACKGROUND: The relative efficacy of streptokinase and tissue plasminogen activator and the roles of intravenous as compared with subcutaneous heparin as adjunctive therapy in acute myocardial infarction are unresolved questions. The current trial was designed to compare new, aggressive

A randomized trial comparing treatments for varicose veins.

Science.gov (United States)

Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion K

2014-09-25

Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (Pdisease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

Albendazole versus praziquantel in the treatment of neurocysticercosis: a meta-analysis of comparative trials.

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Dimitrios K Matthaiou

Full Text Available BACKGROUND: Neurocysticercosis, infection of the brain with larvae of Taenia solium (pork tapeworm, is one of several forms of human cysticercosis caused by this organism. We investigated the role of albendazole and praziquantel in the treatment of patients with parenchymal neurocysticercosis by performing a meta-analysis of comparative trials of their effectiveness and safety. METHODS AND PRINCIPAL FINDINGS: We performed a search in the PubMed database, Cochrane Database of Controlled Trials, and in references of relevant articles. Six studies were included in the meta-analysis. Albendazole was associated with better control of seizures than praziquantel in the pooled data analysis, when the generic inverse variance method was used to combine the incidence of seizure control in the included trials (patients without seizures/[patients x years at risk] (156 patients in 4 studies, point effect estimate [incidence rate ratio] = 4.94, 95% confidence interval 2.45-9.98. In addition, albendazole was associated with better effectiveness than praziquantel in the total disappearance of cysts (335 patients in 6 studies, random effects model, OR = 2.30, 95% CI 1.06-5.00. There was no difference between albendazole and praziquantel in reduction of cysts, proportion of patients with adverse events, and development of intracranial hypertension due to the administered therapy. CONCLUSIONS: A critical review of the available data from comparative trials suggests that albendazole is more effective than praziquantel regarding clinically important outcomes in patients with neurocysticercosis. Nevertheless, given the relative scarcity of trials, more comparative interventional studies--especially randomized controlled trials--are required to draw a safe conclusion about the best regimen for the treatment of patients with parenchymal neurocysticercosis.

Řešení stresové inkontinence moči u žen operační metodou TVT-S – vztah mezi léčebným efektem operační metody a změnami hodnot ultrazvukových parametrů

Czech Academy of Sciences Publication Activity Database

Martan, A.; Švabík, K.; Mašata, J.; Koleska, T.; Haddad El, R.; Pavlíková, Markéta

2008-01-01

Roč. 73, č. 5 (2008), s. 271-277 ISSN 1210-7832 Grant - others:GA MZd(CZ) NR9216 Institutional research plan: CEZ:AV0Z10300504 Keywords : inkontinence moči u žen * komplikace * TVT-S system * transperineální ultrazvukové vyšetření Subject RIV: BB - Applied Statistics, Operational Research

The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia.

Science.gov (United States)

Wee, Michael Y K; Tuckey, Jenny P; Thomas, Peter; Burnard, Sara

2011-07-08

Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours. If the trial demonstrates that diamorphine provides better analgesia

Analysis of 1,000 cases of synthetic midurethral slings used for treatment of female urinary incontinence – a single-center experience

Science.gov (United States)

Kasyan, George; Gvozdev, Michail; Sosnowski, Roman

2011-01-01

Introduction This study summarized our experience in the treatment of 1,081 women with stress urinary incontinence (SUI) using mid-urethral slings. Material and methods The study included 1,081 operated patients. Pure SUI was diagnosed in 77.80% (841) of the patients; another 18.68% (202) had mixed symptoms. The remaining 3.52% (38) suffered from recurrent SUI. Group 1 included the SUI patients treated with TVT. Group 2 – SUI managed with TVT-O. In Group 3, mixed urinary incontinent (MUI) patients were treated with TVT-O. Results Retropubic TVT was used in 273 patients (25.25%) and TVT-O in 740 (68.45%). Other slings were used in 68 patients (6.3%). Mean follow-up for the groups was 50.1, 31.1, and 32.6 months respectively. For objective evaluation of cure rate we used the cough stress test. Subjective efficacy was studied via a visual analog scale. The complication rate in each group of the patients was used as a secondary end point. A negative cough test was found in 85.58% of patients in Group 1. For the TVT-O group, the objective cure rate was 84.36%. Intra-operative complications for TVT and TVT-O were not related to age, BMI, or parity. Bladder perforation and pelvic hematoma developed more frequently in the TVT group. There is a higher risk of vaginal perforation for TVT-O. The objective and subjective cure rates for MUI patients were 86.15% and 87.69% respectively. Conclusions TVT and TVT-O are equally effective and safe methods of treatment for women suffering from SUI and MUI. PMID:24578904

A Comparative Effectiveness Education Trial for Lifestyle Health Behavior Change in African Americans

Science.gov (United States)

Halbert, Chanita Hughes; Bellamy, Scarlett; Briggs, Vanessa; Delmoor, Ernestine; Purnell, Joseph; Rogers, Rodney; Weathers, Benita; Johnson, Jerry C.

2017-01-01

Obesity and excess weight are significant clinical and public health issues that disproportionately affect African Americans because of physical inactivity and unhealthy eating. We compared the effects of alternate behavioral interventions on obesity-related health behaviors. We conducted a comparative effectiveness education trial in a…

A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

Science.gov (United States)

Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

2013-01-01

Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty

Kirurgisk behandling af urininkontinens hos kvinder

DEFF Research Database (Denmark)

Ammendrup, Astrid Cecilie; Sørensen, Helle Christina; Sander, Pia

2010-01-01

(TVT) was the preferred sling in 2006. A total of 20 (47%) UI surgeons used only TVT, seven (17%) only transobturator slings (TOS) and 15 (36%) both TVT and TOS. Only 11 (24%) performed > 25 TVT per year and 11 (27%) performed > 25 TOS per year. In all, UI surgeons had experience with ten different...

Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

OpenAIRE

Williams, N S; Johnston, D

1980-01-01

Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complicati...

Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

Science.gov (United States)

Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Irene Su, H

2016-04-01

Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

Comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: a randomized trial

Science.gov (United States)

Background: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. Objective: To compare Tai Chi with standard physical therapy f...

Expression of P-glycoprotein, multidrug resistance-associated protein, glutathione-S-transferase pi and p53 in canine transmissible venereal tumor

Directory of Open Access Journals (Sweden)

Daniel G. Gerardi

2014-01-01

Full Text Available The overexpression of proteins P-glycoprotein (P-gp, multidrug resistance-associated protein (MRP1, mutant p53, and the enzyme glutathione-S-transferase (GSTpi are related to resistance to chemotherapy in neoplasms. This study evaluated the expression of these markers by immunohistochemistry in two groups of canine TVT, without history of prior chemotherapy (TVT1, n=9 and in TVTs presented unsatisfactory clinical response to vincristine sulfate (TVT2, n=5. The percentage of specimens positively stained for P-gp, MRP1, GSTpi and p53 were, respectively 88.8%, 0%, 44.5% and 22.2% in TVT1 and 80%, 0%, 80% and 0% in TVT2. In TVT1, one specimen presented positive expression for three markers and four specimens for two markers. In TVT2, three specimens expressed P-gp and GSTpi. In conclusion, the canine TVTs studied expressed the four markers evaluated, but just P-gp and GSTpi were significantly expressed, mainly at cytoplasm and cytoplasm and nuclei, respectively, either before chemotherapy as after vincristine sulfate exposure. Future studies are needed to demonstrate the function of these two markers in conferring multidrug resistance (MDR or predict the response to chemotherapy in canine TVT.

Rosemary oil vs minoxidil 2% for the treatment of androgenetic alopecia: a randomized comparative trial.

Science.gov (United States)

Panahi, Yunes; Taghizadeh, Mohsen; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

2015-01-01

Rosmarinus officinalis L. is a medicinal plant with diverse activities including enhancement microcapillary perfusion. The present study aimed to investigate the clinical efficacy of rosemary oil in the treatment of androgenetic alopecia (AGA) and compare its effects with minoxidil 2%. Patients with AGA were randomly assigned to rosemary oil (n = 50) or minoxidil 2% (n = 50) for a period of 6 months. After a baseline visit, patients returned to the clinic for efficacy and safety evaluations every 3 months. A standardized professional microphotographic assessment of each volunteer was taken at the initial interview and after 3 and 6 months of the trial. No significant change was observed in the mean hair count at the 3-month endpoint, neither in the rosemary nor in the minoxidil group (P > .05). In contrast, both groups experienced a significant increase in hair count at the 6-month endpoint compared with the baseline and 3-month endpoint (P .05). The frequencies of dry hair, greasy hair, and dandruff were not found to be significantly different from baseline at either month 3 or month 6 trial in the groups (P > .05). The frequency of scalp itching at the 3- and 6-month trial points was significantly higher compared with baseline in both groups (P minoxidil group at both assessed endpoints (P < .05). The findings of the present trial provided evidence with respect to the efficacy of rosemary oil in the treatment of AGA.

A comparative analysis of quality management standards for contract research organisations in clinical trials.

Science.gov (United States)

Murray, Elizabeth; McAdam, Rodney

2007-01-01

This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

Comparative effectiveness of injection therapies in lateral epicondylitis: a systematic review and network meta-analysis of randomized controlled trials.

Science.gov (United States)

Krogh, Thøger Persson; Bartels, Else Marie; Ellingsen, Torkell; Stengaard-Pedersen, Kristian; Buchbinder, Rachelle; Fredberg, Ulrich; Bliddal, Henning; Christensen, Robin

2013-06-01

Injection therapy with glucocorticoids has been used since the 1950s as a treatment strategy for lateral epicondylitis (tennis elbow). Lately, several novel injection therapies have become available. To assess the comparative effectiveness and safety of injection therapies in patients with lateral epicondylitis. Systematic review and meta-analysis. Randomized controlled trials comparing different injection therapies for lateral epicondylitis were included provided they contained data for change in pain intensity (primary outcome). Trials were assessed using the Cochrane risk of bias tool. Network (random effects) meta-analysis was applied to combine direct and indirect evidence within and across trial data using the final end point reported in the trials, and results for the arm-based network analyses are reported as standardized mean differences (SMDs). Seventeen trials (1381 participants; 3 [18%] at low risk of bias) assessing injection with 8 different treatments-glucocorticoid (10 trials), botulinum toxin (4 trials), autologous blood (3 trials), platelet-rich plasma (2 trials), and polidocanol, glycosaminoglycan, prolotherapy, and hyaluronic acid (1 trial each)-were included. Pooled results (SMD [95% confidence interval]) showed that beyond 8 weeks, glucocorticoid injection was no more effective than placebo (-0.04 [-0.45 to 0.35]), but only 1 trial (which did not include a placebo arm) was at low risk of bias. Although botulinum toxin showed marginal benefit (-0.50 [-0.91 to -0.08]), it caused temporary paresis of finger extension, and all trials were at high risk of bias. Both autologous blood (-1.43 [-2.15 to -0.71]) and platelet-rich plasma (-1.13 [-1.77 to -0.49]) were also statistically superior to placebo, but only 1 trial was at low risk of bias. Prolotherapy (-2.71 [-4.60 to -0.82]) and hyaluronic acid (-5.58 [-6.35 to -4.82]) were both more efficacious than placebo, whereas polidocanol (0.39 [-0.42 to 1.20]) and glycosaminoglycan (-0.32 [-1.02 to 0

Preoperative Valsava leak point pressure may not predict outcome of mid-urethral slings: analysis from a randomized controlled trial of retropubic versus transobturator mid-urethral slings

Directory of Open Access Journals (Sweden)

Elisabetta Costantini

2008-02-01

Full Text Available OBJECTIVE: To test the hypothesis that preoperative Valsalva leak point pressure (VLPP predicts long-term outcome of mid-urethra slings for female stress urinary incontinence (SUI. MATERIALS AND METHODS: One hundred and forty-five patients with SUI were prospectively randomized to two mid-urethra sling treatments: Tension free vaginal tape (TVT or transobturator tape (TOT. They were followed-up at 3, 6, 12 months post-operatively and then annually for the primary outcome variable, i.e. dry or wet and secondary outcome variables such as scores on the urogenital distress inventory (UDI-6 and the impact of incontinence on quality of life (IIQ-7 questionnaire as well as patient satisfaction as scored on a visual analogue scale (VAS. Preoperative VLPP was correlated with primary and secondary outcome variables. RESULTS: Mean follow-ups were 32 + 12 months (range 12-55 for TVT and 31 + 15 months (range 12-61 for TOT. When patients were analyzed according to VLPP stratification, 95 (65.5% patients showed a VLPP > 60 cm H2O and 50 (34.5% patients had a VLPP 60 cm H2O and 72% for those with VLPP 60 cm H2O (82 % vs. 68.9% p of 60 cm H2O, preoperative VLPP was not linked to outcome after TVT or TOT procedures.

Artificial Neural Network Prediction of Chemical-Disease Relationships using Readily Available Chemical Properties

Science.gov (United States)

2014-03-27

C: Additional MATLAB Training Sessions ...................................................106 Appendix D: TVT Graphs...49 Figure 10: TVT Ratio Effect on the Coefficient of Determination .................................. 52 Figure 11: Training Function Effect on...the Coefficient of Determination ....................... 55 Figure 12: Effect of TVT Ratio on MATLAB ANN Derived Disease

Dropout Rates in Randomized Clinical Trials of Antipsychotics: A Meta-analysis Comparing First- and Second-Generation Drugs and an Examination of the Role of Trial Design Features

OpenAIRE

Rabinowitz, Jonathan; Levine, Stephen Z.; Barkai, Orna; Davidov, Ori

2008-01-01

Dropout is often used as an outcome measure in clinical trials of antipsychotic medication. Previous research is inconclusive regarding (a) differences in dropout rates between first- and second-generation antipsychotic medications and (b) how trial design features reduce dropout. Meta-analysis of randomized controlled trials (RCTs) of antipsychotic medication was conducted to compare dropout rates for first- and second-generation antipsychotic drugs and to examine how a broad range of design...

Tension free vaginal tape in the management of genuine stress incontinence in women - the Indian experience

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N Rajamaheswari

2003-01-01

Full Text Available Objectives: To study retrospectively the results of the Tension Free Vaginal Tape (TVT, a new ambulatory sur-gical procedure for the treatment of stress urinary incon-tinence (SUI among Indian women. Methods: TVT implies the implantation of a prolene tape around the mid-uretha via a minimal vaginal incision. TVT was done on 54 patients diagnosed to have Genuine Stress Incontinence (GSI. The procedure was done either under regional anaesthesia (RA or under local anaesthesia (LA with IV analgesics. Results: Thirty-eight patients underwent only the TVT procedure and in 16 patients concomitant procedures were done along with the TVT The TVT was done as the pri-mary procedure for GSI in 46 patients. Eight patients had prior surgery for stress incontinence. All patients were followed up from 6 months to 2 years. Forty-eight (88% patients reported complete cure. There was significant improvement of symptoms in 4(7.4% patients and in 2(3.7% the surgery failed. Conclusions: These results prove that the TVT proce-dure is a minimally invasive, safe and effective method for the treatment of SUI in women.

Usefulness of perineal ultrasonography after tension-free vaginal tape procedure for stress urinary incontinence

International Nuclear Information System (INIS)

Yoon, Seong Kuk

2005-01-01

To evaluate the usefulness of perineal ultrasonography after a tension-free vaginal tape (TVT) procedure in women with stress urinary incontinence. Thirty-four patients with stress urinary incontinence who underwent the TVT procedure were included in this study. We compared the perineal ultrasonography findings before and after the procedure. The mean age was 49 years (rang: 32-75 years) and the mean follow-up time was 9.5 days (range: 5-19 days). We obtained the entire sagittal image of the bladder neck, urethra, urethrovesical junction and symphysis pubis. The posterior urethrovesical angle (PUVA) and descent of the bladder neck at rest and during stress, and the diameter of proximal urethra at rest were all evaluated. We compared these ultrasonographic changes before and after the procedure. Before the TVT procedure, the PUVA was 134.7 ± 5.9 .deg. at rest and 146.8 ± 8.5 .deg. during stress, and the difference between PUVA at rest and during stress was 12.2 ± 7.3 .deg. . After the TVT procedure, the PUVA significantly decreased to 125.6 ± 7.5 .deg. at rest and 132.5 ± 8.3 .deg. during stress, and the difference also significantly decreased to 7.0 ± 5.0 .deg. (ρ < 0.01). Before the procedure, the descent of the bladder neck was 17 ± 7.0 mm, while the descent significantly decreased to 7.7 ± 4.1 mm after the procedure (ρ < 0.01). Before the procedure, the diameter of the proximal urethra was 5.6 ± 1.4 mm at rest, but the diameter was 5.5 ± 1.1 mm, without significant change, after the procedure. Follow-up perineal ultrasonography after the TVT procedure may be useful for evaluating changes including the PUVA, descent and appearance of the bladder neck

Usefulness of perineal ultrasonography after tension-free vaginal tape procedure for stress urinary incontinence

Energy Technology Data Exchange (ETDEWEB)

Yoon, Seong Kuk [Donga University College of Medicine, Busan (Korea, Republic of)

2005-07-15

To evaluate the usefulness of perineal ultrasonography after a tension-free vaginal tape (TVT) procedure in women with stress urinary incontinence. Thirty-four patients with stress urinary incontinence who underwent the TVT procedure were included in this study. We compared the perineal ultrasonography findings before and after the procedure. The mean age was 49 years (rang: 32-75 years) and the mean follow-up time was 9.5 days (range: 5-19 days). We obtained the entire sagittal image of the bladder neck, urethra, urethrovesical junction and symphysis pubis. The posterior urethrovesical angle (PUVA) and descent of the bladder neck at rest and during stress, and the diameter of proximal urethra at rest were all evaluated. We compared these ultrasonographic changes before and after the procedure. Before the TVT procedure, the PUVA was 134.7 {+-} 5.9 .deg. at rest and 146.8 {+-} 8.5 .deg. during stress, and the difference between PUVA at rest and during stress was 12.2 {+-} 7.3 .deg. . After the TVT procedure, the PUVA significantly decreased to 125.6 {+-} 7.5 .deg. at rest and 132.5 {+-} 8.3 .deg. during stress, and the difference also significantly decreased to 7.0 {+-} 5.0 .deg. ({rho} < 0.01). Before the procedure, the descent of the bladder neck was 17 {+-} 7.0 mm, while the descent significantly decreased to 7.7 {+-} 4.1 mm after the procedure ({rho} < 0.01). Before the procedure, the diameter of the proximal urethra was 5.6 {+-} 1.4 mm at rest, but the diameter was 5.5 {+-} 1.1 mm, without significant change, after the procedure. Follow-up perineal ultrasonography after the TVT procedure may be useful for evaluating changes including the PUVA, descent and appearance of the bladder neck.

Comparing Amazon Mechanical Turk with unpaid internet resources in online clinical trials

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Eduardo Bunge

2018-06-01

Full Text Available Internet interventions face significant challenges in recruitment and attrition rates are typically high and problematic. Finding innovative yet scientifically valid avenues for attaining and retaining participants is therefore of considerable importance. The main goal of this study was to compare recruitment process and participants characteristics between two similar randomized control trials of mood management interventions. One of the trials (Bunge et al., 2016 was conducted with participants recruited from Amazon's Mechanical Turk (AMT, and the other trial recruited via Unpaid Internet Resources (UIR. Methods: The AMT sample (Bunge et al., 2016 consisted of 765 adults, and the UIR sample (recruited specifically for this study consisted of 329 adult US residents. Participants' levels of depression, anxiety, confidence, motivation, and perceived usefulness of the intervention were assessed. The AMT sample was financially compensated whereas the UIR was not. Results: AMT yielded higher recruitment rates per month (p < .05. At baseline, the AMT sample reported significantly lower depression and anxiety scores (p < .001 and p < .005, respectively and significantly higher mood, motivation, and confidence (all p < .001 compared to the UIR sample. AMT participants spent significantly less time on the site (p < .05 and were more likely to complete follow-ups than the UIR sample (p < .05. Both samples reported a significant increase in their level of confidence and motivation from pre- to post-intervention. AMT participants showed a significant increase in perceived usefulness of the intervention (p < .0001, whereas the UIR sample did not (p = .1642. Conclusions: By using AMT, researchers can recruit very rapidly and obtain higher retention rates; however, these participants may not be representative of the general online population interested in clinical interventions. Considering that AMT and UIR participants

Which factors influenced the result of a tension free vaginal tape operation in a single teaching hospital?

NARCIS (Netherlands)

Withagen, M.I.J.; Milani, A.L.

2007-01-01

BACKGROUND: Tension free vaginal tape (TVT) has proven to be successful. Nevertheless, complications of the TVT have been reported. The aim of this study was to describe factors that might influence the efficacy and safety of the TVT procedure in our clinic. METHODS: Medical records of all patients

77 FR 53202 - Agency Information Collection Activities: Proposed Collection; Comment Request

Science.gov (United States)

2012-08-31

... Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one... on TAVR. The TVT Registry will support a national surveillance system to monitor the safety and... conduct of the STS/ACC TVT Registry and the KCCQ-10 is in accordance with Section 1142 of the Social...

Sling de aponeurose e com faixa sintética sem tensão para o tratamento cirúrgico da incontinência urinária de esforço feminina Pubovaginal sling and tension-free vaginal tape for surgical treatment of stress urinary incontinence in women

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João Paulo Sartori

2008-03-01

ções detectadas, a retenção urinária no pós-operatório foi superior no Grupo Sling.PURPOSE: to compare sling operations of aponeurosis and tension-free vaginal tape (TVT for the correction of stress urinary incontinence (SUI regarding: the rates of subjective and objective healing, the mobility of the bladder neck with ultrasonography, the variation of the absorbent test, the urodynamic alterations and the incidence of complications. METHODS: eighty patients with SUI were selected. Among them, 61 underwent a TVT surgery and 19, an abdominal rectum sling operation of aponeurosis. Average age, index of body mass and parity were 50.1 years old, 29.7 kg/m² and 4.1 deliveries (median=3 for the patients with aponeurosis sling, and 51.7 years old, 28.1 kg/m² and 4.1 deliveries (median=3 for the ones with TVT. All of them have undergone anamnesis, physical examination, bladder neck ultrasonography, absorbent test and urodynamic evaluation before and at least six months after the surgery. After 15 or 19 months and after about four or five years, they were again interviewed concerning the surgery results. RESULTS: after six months, 96.7% of the women with TVT and 89.5% of the ones with sling thought they were healed in the subjective evaluation. Nevertheless, after 15 to 19 months, the TVT Group kept the same subjective healing rate, while among the Sling Group the rate decreased to 77.8%. There was a significant decrease in the mobility of the neck bladder that was similar in both groups and an improvement in the absorbent test. At the end of the urodynamic study, 93.4% of the women from the TVT Group and 78.9% of the ones from the Sling Group were classified as having an objective healing. The average time of bladder probing was higher in the Sling Group. Urinary retention was observed in 42.1% of the sling cases and in 9.8% of the TVT's. The rates of late healing were 90% for TVT and 55.6% for sling. CONCLUSIONS: TVT surgery provided better subjective healing after 15 or 19

Economic evaluation of the randomized European Achalasia trial comparing pneumodilation with Laparoscopic Heller myotomy

NARCIS (Netherlands)

Moonen, A.; Busch, O.; Costantini, M.; Finotti, E.; Tack, J.; Salvador, R.; Boeckxstaens, G.; Zaninotto, G.

2017-01-01

BackgroundA recent multicenter randomized trial in achalasia patients has shown that pneumatic dilation resulted in equivalent relief of symptoms compared to laparoscopic Heller myotomy. Additionally, the cost of each treatment should be also taken in consideration. Therefore, the aim of the present

Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial: rationale and design

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Schuler Gerhard

2011-02-01

Full Text Available Abstract Background Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO, but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. Methods The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age ( Discussion patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011. Trial Registration Trial listed in ClinicalTrials.gov as NCT00166257 and sponsored by AGA Medical, Plymouth, MN, USA

Did surgical failure and complications affect incontinence-related quality of life in women after transobturator sling procedure?

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Wen-Chu Huang

2018-04-01

Full Text Available Objective: To report the objective outcome, subjective measurement of incontinence-related quality of life (QoL for female urodynamic stress incontinence (USI after transobturator sling surgery (TVT-O and to evaluate the effects of surgical failure and complications on QoL. Materials and methods: We analyzed the data from women who underwent TVT-O for USI and completed two validated QoL questionnaires, the Urogenital Distress Inventory (UDI-6 and Incontinence Impact Questionnaire (IIQ-7 preoperatively and at least 12 months postoperatively. We evaluated the subjective results of QoL questionnaires, objective results and compare the effect of QoL on those with surgical failure and complications after TVT-O surgery. Results: A total of 78 women were followed for a median of 13.5 months (range 12–15 months after surgery. Within this group, 75 (96% were considered subjectively cured or improved after TVT-O. There were significant improvements in the IIQ-7 and total UDI-6 scores postoperatively, as well as in the UDI-6 subscales for urge, stress and voiding dysfunction symptoms. Even the 18 women with objective urodynamic failure had significant improvement in QoL scores. For those with surgical related complications, the QoL scores were also significantly improved. Conclusions: TVT-O for USI resulted in improvement of incontinence-related QoL including urgency, stress, and voiding dysfunction symptoms. Surgical failure and complications didn't impair postoperative QoL. Keywords: Complication, Quality of life, Stress urinary incontinence, Transobturator tape, Urodynamic stress incontinence

CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials

OpenAIRE

Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

2010-01-01

ABSTRACT Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of kn...

Alcohol, indomethacin, and salbutamol. A comparative trial of their use in preterm labor.

Science.gov (United States)

Spearing, G

1979-02-01

In a comparative trial, ethanol effectively arrested preterm labor for 48 hours for more in 32% of cases, a beta-adrenergic agent (salbutamol) in 60% of cases (not statistically significant), and a combination of ethanol and indomethacin in 70% of cases (statistically significant, P less than 0.5). Labor was delayed for 14 days or more in 36, 60, and 50%, respectively (not statistically significant). The numbers studied were small, and tests of statistical significance were of doubtful value. Salbutamol was more acceptable to patients and the staff than ethanol. The trial was suspended and eventually abandoned due to reports of prostaglandin synthetase inhibitors causing premature closure of the ductus arteriosus. In this series no problems were encountered with the use of indomethacin.

Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

Science.gov (United States)

Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

2017-09-26

Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and

Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

Science.gov (United States)

2011-01-01

Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

The Impact of Complications on Patients’ Assessment of the Outcome of Tension-Free Vaginal Tape Procedure

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David Shaker

2017-11-01

Full Text Available Introduction: Our study aimed to assess the impact of managed complications of tension-free vaginal tape (TVT on the patients’ assessment of the results as measured by Patient Global Impression of Improvement (PGI-I. Materials and methods: This was a retrospective study, supplemented with a telephone interview, comparing patients who had complications of TVT procedures with those where no complications recorded. The primary outcome was the PGI-I score in the 2 groups. Results: A total of 118 invitations were sent. In all, 60 patients returned the signed consent and completed the telephone interview with one of the authors (response rate = 50.8%. Complications were recorded in 21 patients (group 1 and no complications in 39 patients (group 2. There was no statistically significant difference between PGI-I in both groups. Conclusions: Managed complications of TVT do not seem to affect patients’ assessment of outcome as measured by PGI-I score.

Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

NARCIS (Netherlands)

Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff

Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

Science.gov (United States)

Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

2014-12-01

Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial

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Jessica L. Thomson

2016-01-01

Full Text Available Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n=82, enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

Transobturator tapes are preferable over transvaginal tapes for the management of female stress urinary incontinence: Against

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Arun Chawla

2009-01-01

Full Text Available Midurethral placement of tension-free vaginal tapes with a transvaginal route for stress urinary incontinence achieves higher and better long-term success rates than the transobturator route. Bladder perforations are reported more in transvaginal tape (TVT but incidences of vaginal erosions, extrusion, and groin pain are exceedingly more in TOT groups. There is no clear evidence that transobturator tape (TOT is associated with less post-operative voiding problems than TVT. Major complications such as bowel injuries and significant vascular injuries with TVT are rare. TVT has been found to be superior to TOT and preferable in technically demanding conditions such as prior anti-incontinence operation failures, obese women, and very elevated and scarred lateral cul-de sac. TVT is always preferred in severe grades of stress urinary incontinence and with patients of intrinsic sphincter deficiency (ISD with little or no urethral mobility.

Security From Detection (Vehicles)

Science.gov (United States)

2011-02-24

Tester ( TVT ) or other TOP 02-2-615A 24 February 2011 5 similar device. Color vision can be assessed using the seven Ishihara Pseudo...Isochromatic plates usually contained in the TVT . b. Personnel chosen as observers for aural detectability tests must also have hearing ability...Test Test Measurement Diagnostic Equipment TOP Test Operations Procedure TVT Titmus® Vision Tester USMC United States Marine Corps

Association of Patient-Reported Health Status with Long-Term Mortality after Transcatheter Aortic Valve Replacement: A Report from the STS/ACC TVT Registry™

Science.gov (United States)

Arnold, Suzanne V.; Spertus, John A.; Vemulapalli, Sreekanth; Dai, Dadi; O’Brien, Sean M.; Baron, Suzanne J.; Kirtane, Ajay J.; Mack, Michael J.; Green, Philip; Reynolds, Matthew R.; Rumsfeld, John S.; Cohen, David J.

2015-01-01

Background Although transcatheter aortic valve replacement (TAVR) is an effective treatment for aortic stenosis, long-term mortality after TAVR remains high and challenging to predict. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a health status measure, assessed directly from patients, that integrates two clinically relevant factors (symptoms and functional status) that may predict TAVR outcomes. Methods and Results Among 7769 patients from 286 sites in the STS-ACC TVT Registry, we examined the association between pre-procedure (baseline) patient health status, as assessed by the KCCQ, and 1-year mortality after TAVR. The KCCQ Overall Summary Score was categorized as very poor: <25, poor: 25–49, fair: 50–74, or good: ≥75. Prior to TAVR, health status was rated as very poor in 28%, poor in 38%, fair in 24%, and good in 10%. Patients with worse health status were more likely to be female and had more comorbidities and higher STS mortality risk scores. Compared with those with good health status prior to TAVR, and after adjusting for a broad range of baseline covariates, patients with very poor health status had a 2-fold increased hazard of death over the first year after TAVR (adjusted HR 2.00, 95% CI 1.58–2.54), while those with poor and fair health status had intermediate outcomes (adjusted HRs 1.54, 95% CI 1.22–1.95 and 1.20, 95% CI 0.94–1.55, respectively). Conclusions In a national, contemporary practice cohort, worse pre-procedure patient health status, as assessed by the KCCQ, was associated with greater long-term mortality after TAVR. These results support the measurement and integration of the KCCQ into mortality risk assessments for patients considering TAVR. PMID:26643740

Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer.

Science.gov (United States)

Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M

2009-07-01

The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.

Pemanfaatan Bahan Organik sebagai Pembawa untuk Peningkatan Kepadatan Populasi Trichoderma viride pada Rizosfir pisang dan Pengaruhnya terhadap Penyakit Layu Fusarium

Directory of Open Access Journals (Sweden)

. Nurbailis

2011-11-01

Full Text Available The aims of the research were to determine the best organic matter as carrier for growth and increasing the density of Trichoderma viride strain TV-T1sk (TV-T1sk and its influence on Fusarium wilt disease development on banana seedling.  This research consisted of two experiments, i.e. (1. Growth  testing of TV-T1sk  in various organic matter, (2. Various organic matter testing for increasing the density of TV-T1sk in banana rhizosphere and its influence on  Fusarium wilt desease development.  The treatments were various organic matter, namely rice straw, sugar cane pulp, rice bran+banana plant waste,  hull of rice+sugar cane pulp and rice. The variables observed were  density and viability of conidia on various organic matter. Propagule density after introduction to banana rhizosphere was determined by observing TV-T1sk propagul from the rizosphere of banana seedling. The influence of density on Fusarium wilt disease development was determined by incubation period, the percentage of symptomized leaves and the intensity of corm damage. The results showed that both sugar cane pulp and rice were the best organic matter  for increasing  the growth and the density  of TV-T1sk  after introduction to banana rhizosphere. The density of TV-T1sk propagule on banana rhizophere influenced  the development of Fusarium wilt disease.

Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

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Mohammad Dehghani Firoozabadi

2014-01-01

Full Text Available Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients and conventional treatment group (30 patients. An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months. Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6 and 32.6 (±12.7 years, respectively (P = 0.45. After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80, frequency of migraine attacks (P = 0.63 and duration of attacks per hours (P = 0.48 were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001. Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

Systematic review and meta-analysis of published, randomized, controlled trials comparing suture anastomosis to stapled anastomosis for ileostomy closure.

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Sajid, M S; Craciunas, L; Baig, M K; Sains, P

2013-12-01

The objective of this article is to systematically analyze the randomized, controlled trials comparing the effectiveness of suture anastomosis (SUA) versus stapled anastomosis (STA) in patients undergoing ileostomy closure. Randomized, controlled trials comparing the effectiveness of SUA versus STA in patients undergoing ileostomy closure were analyzed using RevMan(®), and combined outcomes were expressed as odds risk ratio (OR) and standardized mean difference (SMD). Four randomized, controlled trials that recruited 645 patients were retrieved from electronic databases. There were 327 patients in the STA group and 318 patients in the SUA group. There was significant heterogeneity among included trials. Operative time (SMD -1.02; 95 % CI -1.89, -0.15; z = 2.29; p infection, reoperation and readmission were similar following STA and SUA in patients undergoing ileostomy closure. Length of hospital stay was also similar between STA and SUA groups. In ileostomy closure, STA was associated with shorter operative time and lower risk of postoperative small bowel obstruction. However, STA and SUA were similar in terms of anastomotic leak, surgical site infection, readmission, reoperations and length of hospital stay.

Disseminated transmissible venereal tumour associated with Leishmaniasis in a dog.

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Trevizan, J T; Carreira, J T; Souza, N C; Carvalho, I R; Gomes, P B C; Lima, V M F; Orlandi, C M B; Rozza, D B; Koivisto, M B

2012-12-01

This report addresses an atypical transmissible venereal tumour in an 8-year-old bitch that was pluriparous and seropositive for leishmaniasis. There were ascites and a serosanguineous discharge from the vulva, but no lesions on the external genital mucosa. An aspirate of the peritoneal fluid showed mononuclear round cells characteristic of transmissible venereal tumour (TVT). Exploratory laparotomy revealed light red, granulomatous structures in the peritoneum, omentum, spleen, liver and uterine horns. Cytological and histopathological tests confirmed the diagnosis of intra-abdominal TVT. Dissemination of the TVT to several organs inside the abdominal cavity probably resulted from immunosuppression caused by leishmaniasis, which favoured the presence and aggressiveness of TVT. © 2012 Blackwell Verlag GmbH.

Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

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Titov, Nickolai; Andrews, Gavin; Davies, Matthew; McIntyre, Karen; Robinson, Emma; Solley, Karen

2010-06-08

Internet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided. Would guidance from a technician be as effective as guidance from a clinician? Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health QUESTIONnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (ptechnician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for depression. This form of treatment has potential to increase the capacity of existing mental health services. Australian New

Morphological patterns and malignancy criteria of transmissible venereal tumor in cytopathological and histopathological exams

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Caroline Rocha de Oliveira Lima

2013-06-01

Full Text Available Este estudo teve por objetivo identificar os padrões morfológicos e os critérios de malignidade do TVT aos exames citológico e histopatológico e relacionar essas características à evolução clínica e à resposta à quimioterapia. Dos animais estudados, dezesseis cães eram fêmeas e quatro machos. A idade dos animais variou entre um e dez anos de idade. Quanto à raça, 80% dos cães eram sem raça definida e 20% de outras raças. Constatou-se que as amostras citológicas permitiram melhor caracterização do tipo celular do que as histológicas. O TVT tipo plasmocitoide foi o de maior ocorrência, seguido pelos padrões linfocitoide e misto. Não houve diferença entre os escores estabelecidos para os critérios de malignidade e os tipos do TVT. Nenhum tipo morfológico do TVT diferiu quanto à resposta quimioterápica, mas o TVT apresenta particularidades morfológicas que podem interferir no comportamento tumoral, especialmente aquelas relacionadas à maior agressividade, e que são observadas no TVT plasmocitoide.

Derivation of Grad’s Thirteen Regularized Moment Equations Using a Hermite Polynomial Representation of Velocity Distribution Function (Preprint)

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2010-06-16

B4) Substituting tui  / and tVT  /2 from the momentum and energy conservation law equations, Eqs...B9) Substituting tui  / and tVT  /2 from the momentum and energy conservation law equations, Eqs. (15...Substituting tui  / and tVT  /2 from the momentum and energy conservation law equations, Eqs. (15) and (16), into Eq. (B13) and then dropping all

Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

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Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

2014-07-01

Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

Primary oral and nasal transmissible venereal tumor in a mix-breed dog

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Mahdieh Rezaei

2016-05-01

Full Text Available Transmissible venereal tumor (TVT is a coitally transmitted tumor of dogs with widespread distribution. The present study describes the occurrence of the primary oral and nasal TVT in a 10-year-old, female, mix-breed dog. The case was presented with a history of anorexia, inability to swallow and dyspnea. Clinical examinations revealed the emaciation, muzzle deformity due to the presence of a friable, fleshy, cauliflower-like mass in the oral cavity and submandibular lymphadenopathy. TVT was diagnosed based on histopathological findings. The dog was discharged with therapeutic intervention with vincristine. Unfortunately, the case died before readmission because of the progressive worsening of the general condition. Our findings highlight the need for considering TVT for the differential diagnosis of the extragenital masses in dogs.

Modificações da junção uretrovesical e uretra proximal após a cirurgia de alça sem tensão em mulheres de 45 a 72 anos Urethrovesical junction and proximal urethra changes following tension-free vaginal tape surgery in women aged 45 to 72 years old

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Frederico Teixeira Brandt

2005-06-01

Full Text Available OBJETIVOS: descrever as modificações da junção uretrovesical e uretra proximal decorrentes do uso do Tension-Free Vaginal Tape (TVT, empregado no tratamento da incontinência urinária de esforço (IUE. MÉTODOS: trabalho realizado na Unidade de Pesquisa em Incontinência Urinária da Universidade Federal de Pernambuco. Foram estudadas 22 mulheres com incontinência urinária de esforço foram submetidas à cirurgia do tipo TVT e avaliadas por ultra-sonografia antes e depois da cirurgia. RESULTADOS: os deslocamentos verticais médios da distância vertical da junção uretrovesical no pré e pós-operatório foram respectivamente de 16,7 mm e de 10,7 mm; e os deslocamentos médios da uretra proximal no pré e pós-operatório foram de 13,1 mm e de 6,7 mm (p=0,02. CONCLUSÕES: a cirurgia do tipo TVT, usada no tratamento de mulheres com incontinência urinária de esforço, reduz significativamente a mobilidade vertical da junção uretrovesical (p=0,005 e da uretra proximal (p=0,02.OBJECTIVES: to describe the urethrovesical junction and proximal urethra changes following Tension-free Vaginal Tape (TVT procedure for stress urinary incontinence treatment (SUI. METHODS: this study was performed at the Urinary Incontinence Research Unit of the Universidade Federal de Pernambuco. Twenty two stress urinary incontinence female patients were submitted to TVT. They were evaluated through ultrasound before and following surgery. RESULTS: ultrasound results at rest, before and following TVT surgery, were: mean displacement of urethrovesical junction vertical length, before and after TVT procedure respectively 16,7mm and 10,7 mm; and mean displacement of proximal urethra length, before and following TVT surgery, respectively 13,1 mm and 6,7 mm. CONCLUSIONS: TVT surgery used for treating women with stress urinary incontinence significantly reduces the vertical mobility of the urethrovesical junction (p=0,005 and proximal urethra (p=0,02.

Primary oral and nasal transmissible venereal tumor in a mix-breed dog

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Rezaei, Mahdieh; Azizi, Shahrzad; Shahheidaripour, Shima; Rostami, Sara

2016-01-01

Transmissible venereal tumor (TVT) is a coitally transmitted tumor of dogs with widespread distribution. The present study describes the occurrence of the primary oral and nasal TVT in a 10-year-old, female, mix-breed dog. The case was presented with a history of anorexia, inability to swallow and dyspnea. Clinical examinations revealed the emaciation, muzzle deformity due to the presence of a friable, fleshy, cauliflower-like mass in the oral cavity and submandibular lymphadenopathy. TVT was...

Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design.

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Khattab, Ahmed A; Windecker, Stephan; Jüni, Peter; Hildick-Smith, David; Dudek, Dariusz; Andersen, Henning R; Ibrahim, Reda; Schuler, Gerhard; Walton, Antony S; Wahl, Andreas; Mattle, Heinrich P; Meier, Bernhard

2011-02-28

Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011).

Mortality Risk After Transcatheter Aortic Valve Implantation: Analysis of the Predictive Accuracy of the Transcatheter Valve Therapy Registry Risk Assessment Model.

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Codner, Pablo; Malick, Waqas; Kouz, Remi; Patel, Amisha; Chen, Cheng-Han; Terre, Juan; Landes, Uri; Vahl, Torsten Peter; George, Isaac; Nazif, Tamim; Kirtane, Ajay J; Khalique, Omar K; Hahn, Rebecca T; Leon, Martin B; Kodali, Susheel

2018-05-08

Risk assessment tools currently used to predict mortality in transcatheter aortic valve implantation (TAVI) were designed for patients undergoing cardiac surgery. We aim to assess the accuracy of the TAVI dedicated American College of Cardiology / Transcatheter Valve Therapies (ACC/TVT) risk score in predicting mortality outcomes. Consecutive patients (n=1038) undergoing TAVI at a single institution from 2014 to 2016 were included. The ACC/TVT registry mortality risk score, the Society of Thoracic Surgeons - Patient Reported Outcomes (STS-PROM) score and the EuroSCORE II were calculated for all patients. In hospital and 30-day all-cause mortality rates were 1.3% and 2.9%, respectively. The ACC/TVT risk stratification tool scored higher for patients who died in-hospital than in those who survived the index hospitalization (6.4 ± 4.6 vs. 3.5 ± 1.6, p = 0.03; respectively). The ACC/TVT score showed a high level of discrimination, C-index for in-hospital mortality 0.74, 95% CI [0.59 - 0.88]. There were no significant differences between the performance of the ACC/TVT registry risk score, the EuroSCORE II and the STS-PROM for in hospital and 30-day mortality rates. The ACC/TVT registry risk model is a dedicated tool to aid in the prediction of in-hospital mortality risk after TAVI.

Management of vaginal extrusion after tension-free vaginal tape procedure for urodynamic stress incontinence.

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Giri, Subhasis K; Sil, Debasri; Narasimhulu, Girish; Flood, Hugh D; Skehan, Mark; Drumm, John

2007-06-01

To report our experience in the management of vaginal extrusion after the tension-free vaginal tape (TVT) procedure for urodynamic stress incontinence. Five patients diagnosed with vaginal extrusion after a TVT procedure performed at our institution were identified. We reviewed the patients' records retrospectively. The interval from TVT placement to diagnosis, presenting symptoms and signs, duration of symptoms, diagnostic test findings, treatment, and postoperative results were recorded. Patients were followed up for at least 12 months. From January 2001 to June 2004, a total of 166 patients underwent the TVT procedure. Of these, 5 patients (3%) were diagnosed with isolated vaginal extrusion 4 to 40 months postoperatively. No cases of urethral or bladder erosion occurred in this series. The symptoms included vaginal discharge, pain, bleeding, and dyspareunia. The eroded margin of the vaginal mucosa was trimmed, mobilized, and closed over the tape with interrupted vertical mattress sutures in a single layer using 2-0 polyglactin 910 to avoid mucosal inversion. All patients remained symptom free without any evidence of defective healing or additional extrusion at a minimal follow-up of 12 months. Primary reclosure of the vaginal mucosa over the TVT tape is an effective first-line treatment option for vaginal extrusion without compromising continence. Patients undergoing the TVT procedure should be adequately counseled about the possibility of this complication and the available treatment options.

Obturator Neuralgia: A Rare Complication of Tension-free Vaginal Tape Sling-Complete Resolution After Laparoscopic Tension-free Vaginal Tape Removal.

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Miklos, John R; Moore, Robert D; Chinthakanan, Orawee

2015-01-01

To show a technique of retropubic tension-free vaginal tape (TVT) removal using both a transvaginal and laparoscopic approach in the treatment of a rare condition, obturator neuralgia. A step-by-step explanation of the patient's condition, diagnosis, surgical technique, and postoperative results using video, pictures, and medical illustrations (education video). TVT retropubic slings have become the gold standard for the treatment of stress urine incontinence over the last decade. Despite high cure rates, the TVT is not without potential complications. Typical complications include urine retention, incomplete bladder emptying, frequency, urgency, urethral erosion, vaginal extrusion, vaginal pain, and dyspareunia. The most common complication for sling removal/revision is chronic pain. The TVT obturator neuralgia is a rare and specific type of chronic pain that is normally associated with transobturator tape slings. The purpose of this video is to present an extremely rare complication of TVT retropubic slings, present symptoms and signs of obturator nerve compression, show the normal and the actual position of this patient's TVT sling, describe the laparoscopic removal of the TVT sling, and present the postoperative course and resolution of the patient's pain. The patient signed a release for her video to be used for educational and teaching purposes. A combined transvaginal and laparoscopic approach in a patient with lower abdominal, levator, and obturator-type pain after a TVT retropubic procedure. In patients suffering from obturator neuralgia after a retropubic sling, surgeons should include the sling as a potential causative factor in the differential diagnosis. Surgeons should consider removing the sling based on the patient's symptoms. If the patient suffers from only vaginal pain and dyspareunia, then the surgeon should consider only the removal of the vaginal portion of the sling. In patients with obturator neuralgia, retropubic, and/or lower abdominal

Clinical trial of osteoarthritis jamu formula compare to piroxicam

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Danang Ardiyanto

2016-12-01

is a lack of evidence of its efficacy and safety. The objectives of study were to investigate the efficacy and safety of  a traditional formula for OA. Methods: Design of the study was a randomized clinical trial (RCT involved 123 patients (subjects for 28 days intervention. This study was conducted between March - December 2014 with 30 physicians were participated at 20 regencies in Indonesia. The variables measured were VAS score, PGAP functional status assessment (FSA, and Short Form (SF-36 to assess jamu efficacy in comparison to piroxicam. To evaluate the safety of jamu formula using values of SGOT, SGPT, BUN, and creatinine. Result: The jamu formula administration effects can reduce VAS significantly  (p<0.05  if it was compared to baseline. FSA score of jamu formula group was decreased significantly (p=0.000 when compared to the start of intervention. Short Form (SF-36 of jamu formula group were significantly improved when compared with baseline value. The result of the three parameters between jamu group and piroxicam group should not significantly different. There was no difference in those parameters between both groups (p>0.05. In biological parameters, SGPT, SGOT, BUN, and creatinine level, showed normal range in both groups. Conclusion: This study showed that the efficacy and safety of jamu formula was clinically comparable to piroxicam after 28 days of treatment. Keywords: efficacy, safety, RCT, jamu formula  

Comparative efficacy of simultaneous versus sequential multiple health behavior change interventions among adults: A systematic review of randomised trials.

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James, Erica; Freund, Megan; Booth, Angela; Duncan, Mitch J; Johnson, Natalie; Short, Camille E; Wolfenden, Luke; Stacey, Fiona G; Kay-Lambkin, Frances; Vandelanotte, Corneel

2016-08-01

Growing evidence points to the benefits of addressing multiple health behaviors rather than single behaviors. This review evaluates the relative effectiveness of simultaneous and sequentially delivered multiple health behavior change (MHBC) interventions. Secondary aims were to identify: a) the most effective spacing of sequentially delivered components; b) differences in efficacy of MHBC interventions for adoption/cessation behaviors and lifestyle/addictive behaviors, and; c) differences in trial retention between simultaneously and sequentially delivered interventions. MHBC intervention trials published up to October 2015 were identified through a systematic search. Eligible trials were randomised controlled trials that directly compared simultaneous and sequential delivery of a MHBC intervention. A narrative synthesis was undertaken. Six trials met the inclusion criteria and across these trials the behaviors targeted were smoking, diet, physical activity, and alcohol consumption. Three trials reported a difference in intervention effect between a sequential and simultaneous approach in at least one behavioral outcome. Of these, two trials favoured a sequential approach on smoking. One trial favoured a simultaneous approach on fat intake. There was no difference in retention between sequential and simultaneous approaches. There is limited evidence regarding the relative effectiveness of sequential and simultaneous approaches. Given only three of the six trials observed a difference in intervention effectiveness for one health behavior outcome, and the relatively consistent finding that the sequential and simultaneous approaches were more effective than a usual/minimal care control condition, it appears that both approaches should be considered equally efficacious. PROSPERO registration number: CRD42015027876. Copyright © 2016 Elsevier Inc. All rights reserved.

The effects of Red Bull energy drink compared with caffeine on cycling time-trial performance.

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Quinlivan, Alannah; Irwin, Christopher; Grant, Gary D; Anoopkumar-Dukie, Sheilandra; Skinner, Tina; Leveritt, Michael; Desbrow, Ben

2015-10-01

This study investigated the ergogenic effects of a commercial energy drink (Red Bull) or an equivalent dose of anhydrous caffeine in comparison with a noncaffeinated control beverage on cycling performance. Eleven trained male cyclists (31.7 ± 5.9 y 82.3 ± 6.1 kg, VO2max = 60.3 ± 7.8 mL · kg-1 · min-1) participated in a double-blind, placebo-controlled, crossover-design study involving 3 experimental conditions. Participants were randomly administered Red Bull (9.4 mL/kg body mass [BM] containing 3 mg/kg BM caffeine), anhydrous caffeine (3 mg/kg BM given in capsule form), or a placebo 90 min before commencing a time trial equivalent to 1 h cycling at 75% peak power output. Carbohydrate and fluid volumes were matched across all trials. Performance improved by 109 ± 153 s (2.8%, P = .039) after Red Bull compared with placebo and by 120 ± 172 s (3.1%, P = .043) after caffeine compared with placebo. No significant difference (P > .05) in performance time was detected between Red Bull and caffeine treatments. There was no significant difference (P > .05) in mean heart rate or rating of perceived exertion among the 3 treatments. This study demonstrated that a moderate dose of caffeine consumed as either Red Bull or in anhydrous form enhanced cycling time-trial performance. The ergogenic benefits of Red Bull energy drink are therefore most likely due to the effects of caffeine, with the other ingredients not likely to offer additional benefit.

Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

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NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

2017-08-01

Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

Effect of Resident Performance on Midurethral Sling Cure and Complication Rates

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Sabri Cavkaytar

2016-01-01

Full Text Available Aim: To evaluate the cure rates and complications of midurethral slings performed by residents under an experienced surgeon supervision. Material and Method: Between January 2013 and January 2014, one hundred forty-one midurethral slings performed in the urogynecology clinic of Ankara Zekai Tahir Burak Women%u2019s Health Research and Education Hospital were reviewed.Age, parity,body mass index,menopausal status, grade 2 preoperative pelvic organ prolapsus,concomitant vaginal surgery and intraoperative (bladder and bowel perforations,bleeding,vaginal laceration and early postoperative (urinary retention etc.complications were recorded.All women were re-examined at postoperative 6 th month and symptoms were questioned. The patients were classified as %u2018%u2019cured%u2019%u2019 if the stress test was negative , %u2018%u2019partially cured%u2019%u2019 if continence frequency decreased but still continued and %u2018%u2019unsatisfied%u2019%u2019 if there was no change in symptoms. Both TVT and TOT groups were compared in case of complications and cure rates. Results: Among 141 patients who had undergone midurethral sling due to urinary stress incontinence,50(35.5% were TOT , 91(64.5% were TVT. In the TVT group, 3 (3.3% patients had bleeding which requires transfusion and 5(5.5% patients had bladder perforations. But in the TOT group,there was no bladder perforation and bleeding that requires transfusion. In the early postoperative period, urinary retention was encountered in 7(14.0% patients in TOT group and in 17(18.7% patients in TVT group. There was no statistically significant difference between the groups in case of complications. At postoperative 6th month, in the TOT group 76% of patients were cured,18% were partially cured and 6% were unsatisfied. In the TVT group, 83.5% of patients were cured, 12.1% were partially cured and 4.4% were unsatisfied and there was no significant difference in cure rates between the groups. Discussion: The

Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial

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Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

2018-01-01

Abstract Objectives To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Design Prospective, randomized, 52 week, single blind comparative effectiveness trial. Setting Urban tertiary care academic hospital in the United States between March 2012 and September 2016. Participants 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Interventions Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. Main outcome measures The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient’s global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. Results FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient’s global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with

A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

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Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

2013-02-08

Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

DEFF Research Database (Denmark)

Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

2014-01-01

OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects w...

Results of a randomized trial comparing high-dose chemotherapy plus Auto-SCT and R-FC in CLL at diagnosis.

Science.gov (United States)

Magni, M; Di Nicola, M; Patti, C; Scimè, R; Mulè, A; Rambaldi, A; Intermesoli, T; Viero, P; Tarella, C; Gueli, A; Bergui, L; Trentin, L; Barzan, A; Benedetti, F; Ambrosetti, A; Di Raimondo, F; Chiarenza, A; Parvis, G; Billio, A; Attolico, I; Olivieri, A; Montanari, M; Carlo-Stella, C; Matteucci, P; Devizzi, L; Guidetti, A; Viviani, S; Valagussa, P; Gianni, A M

2014-04-01

The importance of early therapy intensification in B-cell CLL (B-CLL) patients remains to be defined. Even though several studies have been published, no randomized trials comparing directly autologous stem cell transplant (ASCT) and the accepted conventional therapy (that is, rituximab, fludarabine and CY; R-FC) have been reported so far. To assess the benefit of a first-line aggressive therapy, we designed a multicenter, randomized, phase 3 trial comparing R-FC and high-dose chemotherapy supported by ASCT in patients under 65 years of age, with stage B(II) or C B-CLL. Primary end point was CR: 96 patients were enrolled (48 in each arm). On an intent-to-treat basis, the CR rates in the ASCT and R-FC arms were 62.5% and 58%, respectively. After 5 years of follow-up, PFS was 60.4% in the ASCT arm and 65.1% in the R-FC arm, time to progression 65.8 and 70.5%, and overall survival 88% vs 88.1%, respectively. Our trial demonstrates, for the first time in a randomized manner, that frontline ASCT does not translate into a survival advantage when compared with benchmark chemoimmunotherapy in B-CLL patients; the possibility of its clinical benefit in certain subgroups remains uncertain.

Vaginocutaneous fistula and inguinal abcess presented 6 years after tension-free vaginal tape sling

Directory of Open Access Journals (Sweden)

Ali Feyzullah Sahin

2013-06-01

Full Text Available Surgical treatment of female stress urinary incontinence (SUI has become very pop- ular after respectable success with minimal invasive surgeries. This is the first report of long term vaginocutaneous fistula (VCF plus inguinal abcess after tension-free vaginal tape (TVT. A 67 year-old woman with vaginal discharge lasting more than 3 years complained with a painful swelling in the left inguinal area for the last three months. She had a medical history of TVT sling procedure for SUI six years ago. She had no history of pelvic surgery, cancer treatment or pelvic irradiation before or after TVT sling. No urethrovaginal or vesicovaginal fistula was found in physical examination and cystocopy. MRI showed a vaginocutenaous fistula and inguinal abcess. This case highlights the need for a high index of suspicion for VCF after TVT.

The urethral closure function in continent and stress urinary incontinent women assessed by urethral pressure reflectometry

DEFF Research Database (Denmark)

Saaby, Marie-Louise

2014-01-01

, the parameters showed highly significant negative correlation with ICIQ-SF, pad test and the number of incontinence episodes per week and are therefore valid as urodynamic severity measures. UPR in SUI women before and after TVT demonstrated a more efficient urethral closure function after the operation. The Po......-rest was unchanged suggesting that the sphincteric unit was virtually unaltered and hence the permanent closure forces unchanged. However, the resting opening elastance increased by 18% indicating that at the resting state the TVT somewhat improves the closure function by providing increased resistance against...... the dilation of the urethra, which probably explains the decreased maximum urine flow rate found after TVT in this and previous studies. The APIR increased in all patients after TVT suggesting that the support system was re-established and thus the adjunctive closure forces improved, regardless of the type...

Tieto- ja viestintätekniikan opetuskäyttö opettajaksi opiskelevien harjoittelutilanteissa ja siihen vaikuttaneet tekijät

OpenAIRE

Fagerlund, Janne

2015-01-01

Tässä tutkimuksessa selvitettiin luokanopettajaopiskelijoiden kokemuksia tieto- ja viestintätekniikan (TVT) opetuskäytössä opettajankoulutuksen mahdollistamissa harjoittelutilanteissa sekä käyttöön vaikuttaneita tekijöitä. TVT:n opetuskäyttö on eräs kasvatuksen ja koulutuksen ajankohtaisimmista ja tutkituimmista osa-alueista, sillä sen hyötyjä opetuksessa ja oppimisessa voidaan perustella monista pedagogisista näkökulmista. TVT:n opetuskäyttö on sekä kansainvälisten että valtakunnallisten tut...

The effects of honey compared to silver sulfadiazine for the treatment of burns: A systematic review of randomized controlled trials.

Science.gov (United States)

Aziz, Zoriah; Abdul Rasool Hassan, Bassam

2017-02-01

Evidence from animal studies and trials suggests that honey may accelerate wound healing. The objective of this review was to assess the effects of honey compared with silver dressings on the healing of burn wounds. Relevant databases for randomized controlled trials (RCTs) of honey compared with silver sulfadiazine (SSD) were searched. The quality of the selected trials was assessed using the Cochrane Risk of Bias Assessment Tool. The primary endpoints considered were wound healing time and the number of infected wounds rendered sterile. Nine RCTs met the inclusion criteria. Based on moderate quality evidence there was a statistically significant difference between the two groups, favoring honey in healing time (MD -5.76days, 95% CI -8.14 to -3.39) and the proportions of infected wounds rendered sterile (RR 2.59; 95% CI 1.58-2.88). The available evidence suggests that honey dressings promote better wound healing than silver sulfadiazine for burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Study protocol for "Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)": a pragmatic trial comparing implementation strategies.

Science.gov (United States)

Gold, Rachel; Hollombe, Celine; Bunce, Arwen; Nelson, Christine; Davis, James V; Cowburn, Stuart; Perrin, Nancy; DeVoe, Jennifer; Mossman, Ned; Boles, Bruce; Horberg, Michael; Dearing, James W; Jaworski, Victoria; Cohen, Deborah; Smith, David

2015-10-16

Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies' effectiveness in the community health center setting. This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics' ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the "how" and "why" underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in "real-world" practices. Having a better understanding of how different

Palm Oil Consumption Increases LDL Cholesterol Compared with Vegetable Oils Low in Saturated Fat in a Meta-Analysis of Clinical Trials.

Science.gov (United States)

Sun, Ye; Neelakantan, Nithya; Wu, Yi; Lote-Oke, Rashmi; Pan, An; van Dam, Rob M

2015-07-01

Palm oil contains a high amount of saturated fat compared with most other vegetable oils, but studies have reported inconsistent effects of palm oil on blood lipids. We systematically reviewed the effect of palm oil consumption on blood lipids compared with other cooking oils using data from clinical trials. We searched PubMed and the Cochrane Library for trials of at least 2 wk duration that compared the effects of palm oil consumption with any of the predefined comparison oils: vegetable oils low in saturated fat, trans fat-containing partially hydrogenated vegetable oils, and animal fats. Data were pooled by using random-effects meta-analysis. Palm oil significantly increased LDL cholesterol by 0.24 mmol/L (95% CI: 0.13, 0.35 mmol/L; I(2) = 83.2%) compared with vegetable oils low in saturated fat. This effect was observed in randomized trials (0.31 mmol/L; 95% CI: 0.20, 0.42 mmol/L) but not in nonrandomized trials (0.03 mmol/L; 95% CI: -0.15, 0.20 mmol/L; P-difference = 0.02). Among randomized trials, only modest heterogeneity in study results remained after considering the test oil dose and the comparison oil type (I(2) = 27.5%). Palm oil increased HDL cholesterol by 0.02 mmol/L (95% CI: 0.01, 0.04 mmol/L; I(2) = 49.8%) compared with vegetable oils low in saturated fat and by 0.09 mmol/L (95% CI: 0.06, 0.11 mmol/L; I(2) = 47.8%) compared with trans fat-containing oils. Palm oil consumption results in higher LDL cholesterol than do vegetable oils low in saturated fat and higher HDL cholesterol than do trans fat-containing oils in humans. The effects of palm oil on blood lipids are as expected on the basis of its high saturated fat content, which supports the reduction in palm oil use by replacement with vegetable oils low in saturated and trans fat. This systematic review was registered with the PROSPERO registry at http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42012002601#.VU3wvSGeDRZ as CRD42012002601. © 2015 American Society for Nutrition.

Inclusion of Functional Status Measures in the Risk Adjustment of 30-Day Mortality After Transcatheter Aortic Valve Replacement: A Report From the Society of Thoracic Surgeons/American College of Cardiology TVT Registry.

Science.gov (United States)

Arnold, Suzanne V; O'Brien, Sean M; Vemulapalli, Sreekanth; Cohen, David J; Stebbins, Amanda; Brennan, J Matthew; Shahian, David M; Grover, Fred L; Holmes, David R; Thourani, Vinod H; Peterson, Eric D; Edwards, Fred H

2018-03-26

The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty. Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients. Using data from patients who underwent TAVR as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry (June 2013 to May 2016), a hierarchical logistic regression model to estimate risk for 30-day mortality after TAVR based only on pre-procedural factors and access site was developed and internally validated. The model included factors from the original TVT Registry in-hospital mortality model but added the Kansas City Cardiomyopathy Questionnaire (health status) and gait speed (5-m walk test). Among 21,661 TAVR patients at 188 sites, 1,025 (4.7%) died within 30 days. Independent predictors of 30-day death included older age, low body weight, worse renal function, peripheral artery disease, home oxygen, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status, and inability to walk. The predicted 30-day mortality risk ranged from 1.1% (lowest decile of risk) to 13.8% (highest decile of risk). The model was able to stratify risk on the basis of patient factors with good discrimination (C = 0.71 [derivation], C = 0.70 [split-sample validation]) and excellent calibration, both overall and in key patient subgroups. A clinical risk model was developed for 30-day death after TAVR that included clinical data as well as health status and frailty. This model will facilitate tracking outcomes over time as TAVR expands to lower risk patients and

Relative sensory sparing in the diabetic foot implied through vibration testing

Directory of Open Access Journals (Sweden)

Todd O'Brien

2013-09-01

Full Text Available Background: The dorsal aspect of the hallux is often cited as the anatomic location of choice for vibration testing in the feet of diabetic patients. To validate this preference, vibration tests were performed and compared at the hallux and 5th metatarsal head in diabetic patients with established neuropathy. Methods: Twenty-eight neuropathic, diabetic patients and 17 non-neuropathic, non-diabetic patients underwent timed vibration testing (TVT with a novel 128 Hz electronic tuning fork (ETF at the hallux and 5th metatarsal head. Results: TVT values in the feet of diabetic patients were found to be reduced at both locations compared to controls. Unexpectedly, these values were significantly lower at the hallux (P < 0.001 compared to the 5th metatarsal head. Conclusion: This study confirms the hallux as the most appropriate location for vibration testing and implies relative sensory sparing at the 5th metatarsal head, a finding not previously reported in diabetic patients.

Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial.

Science.gov (United States)

Molt, Mats; Toksvig-Larsen, Sören

2014-10-01

The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.

Long-term follow-up of sexual function in women after tension-free vaginal tape operation for stress urinary incontinence

DEFF Research Database (Denmark)

Glavind, Karin; Lindquist, Anna Sofie Inger

negative emotional reactions during intercourse, less coital incontinence, and less fear of being incontinent during intercourse after the TVT operation. CONCLUSION: This study shows that a woman's sex life does not deteriorate after a TVT operation, that their sexual function improves somewhat...

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

Directory of Open Access Journals (Sweden)

Duszynski Katherine M

2011-01-01

Full Text Available Abstract Background The Vaccine Assessment using Linked Data (VALiD trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods/Design Single-centre, single-blind, randomised controlled trial (RCT stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response. A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. Discussion The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12610000332022

Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial).

Science.gov (United States)

Fieten, Karin B; Zijlstra, Wieneke T; van Os-Medendorp, Harmieke; Meijer, Yolanda; Venema, Monica Uniken; Rijssenbeek-Nouwens, Lous; l'Hoir, Monique P; Bruijnzeel-Koomen, Carla A; Pasmans, Suzanne G M A

2014-03-26

About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking. This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children's Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children's Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters. The results of this trial will provide

Long-term Outcomes of Tension-free Vaginal Tape Procedure for Treatment of Female Stress Urinary Incontinence with Intrinsic Sphincter Deficiency

Directory of Open Access Journals (Sweden)

Gwoan-Youb Choo

2012-03-01

Full Text Available Purpose To assess the long-term outcomes of tension-free vaginal tape (TVT for stress urinary incontinence (SUI with intrinsic sphincter deficiency (ISD and to identify influencing factors for failure in these cases. Methods A total of 136 women who underwent TVT procedures with minimum follow-up duration of 3 years were included in the study. Patients were divided into two groups (non-ISD and ISD groups based on preoperative urodynamic studies. Patient outcomes were assessed from retrospective chart review and telephone research. Cure was defined as the subjective resolution of SUI in any circumstances. Improvement was defined as the subjective improvement of SUI without complete resolution. Failure was defined as the subjective lack of improvement of SUI. Patients in ISD group were subdivided into two subgroups (cure and non-cure groups and were compared to identify influencing factors for TVT procedure failure. Results Eighty-nine patients were in non-ISD group, and 47 in ISD group. The mean follow-up durations were 50.3±9.2 and 49.7±9.7 months, respectively. Subjective cure rate was 75.3% for non-ISD group, and 76.7% for ISD group (P>0.05. Improvement rate was 6.7% for non-ISD group, and 2.1% for ISD group (P>0.05. Satisfaction scores was 3.8±1.2 points in the non-ISD group, and 3.5±1.2 points in ISD group (P>0.05. In ISD subgroups, VLPP was 41.9±12.0 cmH2O for non-cure group, and 50.5±8.6 cmH2O for cure group, and was the only factor that showed significant statistical difference between the two subgroups (P=0.011. Conclusions With our long-term results, TVT is an effective treatment even in women with ISD. However, ISD patients with low VLPP should be counseled carefully about TVT outcome.

Protocol for the saMS trial (supportive adjustment for multiple sclerosis: a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

Directory of Open Access Journals (Sweden)

McCrone Paul

2009-08-01

Full Text Available Abstract Background Multiple Sclerosis (MS is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks, mid-therapy (week 5 of therapy, post-therapy (15 weeks and at six months (26 weeks and twelve months (52 weeks follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the

Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

DEFF Research Database (Denmark)

Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

2009-01-01

were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... uncertainty, as indicated by the confidence intervals for the three SMDs. The conditions that had the most pronounced spontaneous improvement were nausea (45%), smoking (40%), depression (35%), phobia (34%) and acute pain (25%). CONCLUSION: Spontaneous improvement and effect of placebo contributed importantly...

Randomized Trial of a Smartphone Mobile Application Compared to Text Messaging to Support Smoking Cessation

OpenAIRE

Buller, David B.; Borland, Ron; Bettinghaus, Erwin P.; Shane, James H.; Zimmerman, Donald E.

2014-01-01

Background: Text messaging has successfully supported smoking cessation. This study compares a mobile application with text messaging to support smoking cessation. Materials and Methods: Young adult smokers 18–30 years old (n=102) participated in a randomized pretest–posttest trial. Smokers received a smartphone application (REQ-Mobile) with short messages and interactive tools or a text messaging system (onQ), managed by an expert system. Self-reported usability of REQ-Mobile and qu...

The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

Directory of Open Access Journals (Sweden)

Gerritsen Pieter G

2009-09-01

Full Text Available Abstract Background Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. Methods The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work and recurrence. Both groups will be evaluated. Success rate of hernia repair and complications will be measured as safeguard for quality. To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP technique reduces postoperative pain to Discussion The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP technique, compared to Lichtenstein. In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. Trial registration ISRCTN 93798494

A Self-Adaptive Energy-Efficient Framework for Large Unattended Wireless Sensor Networks

Science.gov (United States)

2014-11-06

Transactions on Vehicular Technology, (10 2011): 3919. doi: 10.1109/ TVT .2011.2166093 Miao Zhao, Yuanyuan Yang. Optimization-Based DistributedAlgorithms for...Networks, IEEE Transactions on Vehicular Technology, (05 2013): 0. doi: 10.1109/ TVT .2012.2229309 Miao Zhao, Ming Ma, Yuanyuan Yang. Applying

Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

Science.gov (United States)

Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

2010-01-01

This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

Ciclosporin compared with prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial.

Science.gov (United States)

Mason, J M; Thomas, K S; Ormerod, A D; Craig, F E; Mitchell, E; Norrie, J; Williams, H C

2017-12-01

Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomized controlled trial (RCT). To compare the cost-effectiveness of ciclosporin and prednisolone-initiated treatment for patients with PG. Quality of life (QoL, EuroQoL five dimensions three level questionnaire, EQ-5D-3L) and resource data were collected as part of the STOP GAP trial: a multicentre, parallel-group, observer-blind RCT. Within-trial analysis used bivariate regression of costs and quality-adjusted life years (QALYs), with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective. In the base case analysis, when compared with prednisolone, ciclosporin was cost-effective due to a reduction in costs [net cost: -£1160; 95% confidence interval (CI) -2991 to 672] and improvement in QoL (net QALYs: 0·055; 95% CI 0·018-0·093). However, this finding appears driven by a minority of patients with large lesions (≥ 20 cm 2 ) (net cost: -£5310; 95% CI -9729 to -891; net QALYs: 0·077; 95% CI 0·004-0·151). The incremental cost-effectiveness of ciclosporin for the majority of patients with smaller lesions was £23 374/QALY, although the estimate is imprecise: the probability of being cost-effective at a willingness-to-pay of £20 000/QALY was 43%. Consistent with the clinical findings of the STOP GAP trial, patients with small lesions should receive treatment guided by the side-effect profiles of the drugs and patient preference - neither strategy is clearly a preferred use of National Health Service resources. However, ciclosporin-initiated treatment may be more cost-effective for patients with large lesions. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Clinical Trials

Medline Plus

Full Text Available ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ... DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs ...

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

OpenAIRE

Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

2011-01-01

Abstract Background The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods...

A Bayesian Analysis of a Randomized Clinical Trial Comparing Antimetabolite Therapies for Non-Infectious Uveitis.

Science.gov (United States)

Browne, Erica N; Rathinam, Sivakumar R; Kanakath, Anuradha; Thundikandy, Radhika; Babu, Manohar; Lietman, Thomas M; Acharya, Nisha R

2017-02-01

To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts' estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial's primary outcome. A total of 11 of the 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03-45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1-1.2) and 0.7 (95% CrI 0.2-1.7) from the Bayesian analysis. A Bayesian analysis combining expert belief with the trial's result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT.

Outcome and complications of retropubic and transobturator midurethral slings translated into surgical therapeutic indices

NARCIS (Netherlands)

Houwert, R. Marijn; Roovers, Jan Paul W. R.; Venema, Pieter L.; Bruinse, Hein W.; Dijkgraaf, Marcel G. W.; Vervest, Harry A. M.

2010-01-01

OBJECTIVE: We sought to determine and compare surgical therapeutic indices (STIs) of the retropubic tension-free vaginal tape (TVT) and 2 kinds of transobturator tape (TOT), Monarc (American Medical Systems, Minneapolis, MN), and tension-free vaginal tape obturator. STUDY DESIGN: This was a

Acute migraine therapy: recent evidence from randomized comparative trials

DEFF Research Database (Denmark)

Mett, A.; Tfelt-Hansen, P.

2008-01-01

(1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria. (2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved...

Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

Directory of Open Access Journals (Sweden)

Russell Dianne

2007-09-01

Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

Dextrose saline compared with normal saline rehydration of hyperemesis gravidarum: a randomized controlled trial.

Science.gov (United States)

Tan, Peng Chiong; Norazilah, Mat Jin; Omar, Siti Zawiah

2013-02-01

To compare 5% dextrose-0.9% saline against 0.9% saline solution in the intravenous rehydration of hyperemesis gravidarum. Women at their first hospitalization for hyperemesis gravidarum were enrolled on admission to the ward and randomly assigned to receive either 5% dextrose-0.9% saline or 0.9% saline by intravenous infusion at a rate 125 mL/h over 24 hours in a double-blind trial. All participants also received thiamine and an antiemetic intravenously. Oral intake was allowed as tolerated. Primary outcomes were resolution of ketonuria and well-being (by 10-point visual numerical rating scale) at 24 hours. Nausea visual numerical rating scale scores were obtained every 8 hours for 24 hours. Persistent ketonuria rates after the 24-hour study period were 10 of 101 (9.9%) compared with 11 of 101 (10.9%) (P>.99; relative risk 0.9, 95% confidence interval 0.4-2.2) and median (interquartile range) well-being scores at 24 hours were 9 (8-10) compared with 9 (8-9.5) (P=.73) in the 5% dextrose-0.9% saline and 0.9% saline arms, respectively. Repeated measures analysis of variance of the nausea visual numerical rating scale score as assessed every 8 hours during the 24-hour study period showed a significant difference in favor of the 5% dextrose-0.9% saline arm (P=.046) with the superiority apparent at 8 and 16 hours, but the advantage had dissipated by 24 hours. Secondary outcomes of vomiting, resolution of hyponatremia, hypochloremia and hypokalemia, length of hospitalization, duration of intravenous antiemetic, and rehydration were not different. Intravenous rehydration with 5% dextrose-0.9% saline or 0.9% saline solution in women hospitalized for hyperemesis gravidarum produced similar outcomes. ISRCTN Register, www.controlled-trials.com/isrctn, ISRCTN65014409. I.

Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

NARCIS (Netherlands)

Gelade, K.; Janssen, T.W.P.; Bink, M.; van Mourik, R.; Maras, A.; Oosterlaan, J.

2016-01-01

Objective: The efficacy of neurofeedback as treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, are still intensely debated subjects. The current randomised controlled trial compared neurofeedback to (1) optimally

Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

NARCIS (Netherlands)

Geladé, Katleen; Janssen, Tieme W. P.; Bink, Marleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

2016-01-01

The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, is still an intensely debated subject. The current randomized controlled trial compared neurofeedback to (1) optimally

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

Science.gov (United States)

Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

2011-01-04

The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

Cost utility analysis of co-prescribed heroin compared with methadone maintenance treatment in heroin addicts in two randomised trials

NARCIS (Netherlands)

Dijkgraaf, Marcel G. W.; van der Zanden, Bart P.; de Borgie, Corianne A. J. M.; Blanken, Peter; van Ree, Jan M.; van den Brink, Wim

2005-01-01

Objective To determine the cost utility of medical co-prescription of heroin compared with methadone maintenance treatment for chronic, treatment resistant heroin addicts. Design Cost utility analysis of two pooled open label randomised controlled trials. Setting Methadone maintenance programmes in

A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

Science.gov (United States)

Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

2014-11-11

Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial

Directory of Open Access Journals (Sweden)

Hayes Rachel

2010-10-01

Full Text Available Abstract Background Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care. This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a depression free days, (b residual depressive symptoms, (c antidepressant (ADM usage, (d psychiatric and medical co-morbidity, (e quality of life, and (f cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change? Methods/Design The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences

The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.

Science.gov (United States)

Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; Ray, Kathryn J; Zegans, Michael E; McLeod, Stephen D; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M

2013-04-01

To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycintreated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=0.18 logMAR; 95% CI, 0.30 to 0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=0.41 logMAR; 95% CI,0.61 to 0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=0.02 logMAR; 95% CI, 0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Voriconazole should not be used as monotherapy in filamentous keratitis. clinicaltrials.gov Identifier: NCT00996736

Economic evaluation of the randomized European Achalasia trial comparing pneumodilation with Laparoscopic Heller myotomy.

Science.gov (United States)

Moonen, A; Busch, O; Costantini, M; Finotti, E; Tack, J; Salvador, R; Boeckxstaens, G; Zaninotto, G

2017-11-01

A recent multicenter randomized trial in achalasia patients has shown that pneumatic dilation resulted in equivalent relief of symptoms compared to laparoscopic Heller myotomy. Additionally, the cost of each treatment should be also taken in consideration. Therefore, the aim of the present study was to perform an economic analysis of the European achalasia trial. Patients with newly diagnosed achalasia were enrolled from to 2003 to 2008 in 14 centers in five European countries and were randomly assigned to either pneumatic dilation (PD) or laparoscopic Heller (LHM). The economic analysis was performed in the three centers in three different countries where most patients were enrolled (Amsterdam [NL], Leuven, [B] and Padova [I]) and then applied to all patients included in the study. The total raw costs of the two treatments per patient include the initial costs, the costs of complications, and the costs of retreatments. Two hundred and one patients, 107 (57 males and 50 females, mean age 46 CI: 43-49 years) were randomized to LHM and 94 (59 males and 34 females, mean age 46 CI 43-50 years) to PD. The total cost of PD per patient was quite comparable in the three different centers; €3397 in Padova, €3259 in Amsterdam and €3792 in Leuven. For LHM, the total costs per patient were highest in Amsterdam: €4488 in Padova, €6720 in Amsterdam, and €5856 in Leuven. In conclusion, the strategy of treating achalasia starting with PD appears the most economic approach, independent of the health system. © 2017 John Wiley & Sons Ltd.

A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

Science.gov (United States)

Wang, Chenchen; McAlindon, Timothy; Fielding, Roger A; Harvey, William F; Driban, Jeffrey B; Price, Lori Lyn; Kalish, Robert; Schmid, Anna; Scott, Tammy M; Schmid, Christopher H

2015-01-30

Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short

PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

Science.gov (United States)

Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

2015-11-17

Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

Procedural Experience for Transcatheter Aortic Valve Replacement and Relation to Outcomes: The STS/ACC TVT Registry.

Science.gov (United States)

Carroll, John D; Vemulapalli, Sreekanth; Dai, Dadi; Matsouaka, Roland; Blackstone, Eugene; Edwards, Fred; Masoudi, Frederick A; Mack, Michael; Peterson, Eric D; Holmes, David; Rumsfeld, John S; Tuzcu, E Murat; Grover, Frederick

2017-07-04

Transcatheter aortic valve replacement (TAVR) has been introduced into U.S. clinical practice with efforts to optimize outcomes and minimize the learning curve. The goal of this study was to assess the degree to which increasing experience during the introduction of this procedure, separated from other outcome determinants including patient and procedural characteristics, is associated with outcomes. The authors evaluated the association of hospital TAVR volume and patient outcomes for TAVR by using data from 42,988 commercial procedures conducted at 395 hospitals submitting to the Transcatheter Valve Therapy Registry from 2011 through 2015. Outcomes assessed included adjusted and unadjusted in-hospital major adverse events. Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003), and bleeding (p < 0.001) but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume-outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57% to 2.15%), bleeding (9.56% to 5.08%), vascular complications (6.11% to 4.20%), and stroke (2.03% to 1.66%). Vascular and bleeding volume-outcome associations were nonlinear with a higher risk of adverse outcomes in the first 100 cases. An association of procedure volume with risk-adjusted outcomes was also seen in the subgroup having transfemoral access. The initial adoption of TAVR into practice in the United States showed that increasing experience was associated with better outcomes. This association, whether deemed a prolonged learning curve or a manifestation of a volume-outcome relationship, suggested that concentrating experience in higher volume heart valve centers might be a means of improving outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All

Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thromboembolic infrainguinal disease (DUET: design and rationale

Directory of Open Access Journals (Sweden)

Fioole Bram

2011-01-01

Full Text Available Abstract Background The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurrence of bleeding complications. Low intensity ultrasound (US has been shown to accelerate enzymatic thrombolysis, thereby reducing therapy time. So far, no randomized trials have investigated the application of US-accelerated thrombolysis in the treatment of thrombosed infra-inguinal native arteries or bypass grafts. The DUET study (Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thrombo-embolic infrainguinal disease is designed to assess whether US-accelerated thrombolysis will reduce therapy time significantly compared with standard catheter-directed thrombolysis. Methods/design Sixty adult patients with recently (between 1 and 7 weeks thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia class I or IIa, according to the Rutherford classification for acute ischemia, will be randomly allocated to either standard thrombolysis (group A or US-accelerated thrombolysis (group B. Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft, with outflow through at least 1 crural artery. Discussion The DUET study is a randomized controlled trial that will provide evidence of whether US-accelerated thrombolysis will significantly reduce therapy time in patients with recently thrombosed infrainguinal native arteries or bypass grafts, without an increase in complications. Trial registration Current Controlled Trials ISRCTN72676102

Analysis of complications in a prospective randomized trial comparing two brachytherapy low dose rates in cervical carcinoma

Energy Technology Data Exchange (ETDEWEB)

NONE

1994-07-30

The analysis of complications in a prospective randomized trial comparing two preoperative brachytherapy low-dose rates in early stage cervical cancer is presented. The objective of this trial was to determine the benefits, if any, of the higher-dose rate within the therapeutic aresenal for this patient population, in terms of survival, local control, and complications. Overall survival, 85% at 2 years and local control, 93% at 2 years, were similarly distributed between the two groups. Regardless of their nature and severity, 139 and 175 complications were observed among 63% and 75% of patients, in the 0.4 and 0.8 Gy/h dose rate groups respectively. Gynecologic and urinary complications were the most frequent (38% and 28% of all complications), followed by vascular (15%), digestive (10%), nervous (5%), and cutaneous (5%). A total of 14 and 17 severe complications (Grade 3) were observed in 7% and 13% of patients, respectively in the 0.4 and 0.8 Gy/h dose rate groups (p = 0.12) Nonparametric survival methods used to compare the time to the first complication did not show a significant difference between the two groups: 62% and 72% at 2 years (p = 0.27). When the first complication and its evolution were considered (early complications), the prevalence of complications was not significantly different between the two groups: 28% vs. 34% at 2 years (p = 0.31). In this prospective trial, patients were regularly followed-up and complications of varying nature and severity were observed in succession during follow-up. When successive complications and their evolution were taken into account, the prevalence of complications was significantly greater in the higher-dose rate group: 30% vs 45% at 2 years (p = 0.03). The results of this trial showed that long-term effects of treatment, when represented by prevalence of complications over time, were more frequent in the higher dose rate group. 33 refs., 3 figs., 5 tabs.

Conservative treatment of a mandibular condyle fracture: comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

NARCIS (Netherlands)

van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

2015-01-01

Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

NARCIS (Netherlands)

van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

2015-01-01

Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

Science.gov (United States)

MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

2013-01-01

Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

Physical activity and trial-by-trial adjustments of response conflict.

Science.gov (United States)

Kamijo, Keita; Takeda, Yuji

2013-08-01

The relationship of physical activity to trial-by-trial adjustments of response conflict was assessed using behavioral task performance, the N2 event-related brain potential component, and phase-locking values (PLVs) in a lower gamma band during a perceptual conflict task. Nineteen physically active and 19 inactive young adults (mean age = 21.3 years) performed a Navon task, using a global letter made up of local letters of either the same kind (congruent trials) or a different kind (incongruent trials). Findings revealed that active individuals exhibited smaller N2 amplitudes and greater PLVs on incongruent trials that were preceded by incongruent trials compared with those preceded by congruent trials. Such phenomena were not observed for inactive individuals. These results suggest that greater physical activity is associated with larger trial-by-trial adjustments of response conflict, which we attribute to upregulation of top-down cognitive control and reductions in response conflict.

Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs. technician assistance.

Science.gov (United States)

Robinson, Emma; Titov, Nickolai; Andrews, Gavin; McIntyre, Karen; Schwencke, Genevieve; Solley, Karen

2010-06-03

Internet-based cognitive behavioural therapy (iCBT) for generalized anxiety disorder (GAD) has been shown to be effective when guided by a clinician. The present study sought to replicate this finding, and determine whether support from a technician is as effective as guidance from a clinician. Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program and 150 participants with GAD were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for GAD comprising six online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 10 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Penn State Worry Questionnaire (PSWQ) and the Generalized Anxiety Disorder-7 Item (GAD-7). Completion rates were high, and both treatment groups reduced scores on the PSWQ (ptechnician-assisted groups, respectively, and on the GAD-7 were 1.55 and 1.73, respectively. At 3 month follow-up participants in both treatment groups had sustained the gains made at post-treatment. Participants in the clinician-assisted group had made further gains on the PSWQ. Approximately 81 minutes of clinician time and 75 minutes of technician time were required per participant during the 10 week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment/control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for GAD. This form of treatment has potential to increase the

Immunocytochemical characterization of primary cell culture in canine transmissible venereal tumor

Directory of Open Access Journals (Sweden)

Luis M.M. Flórez

Full Text Available Abstract: Immunochemistry with anti-vimentin, anti-lysozyme, anti-alpha 1 antitrypsin, anti-CD3 and anti-CD79α antibodies has been used for characterization of primary cell culture in the transmissible venereal tumor (TVT. Samples for primary cell culture and immunohistochemistry assays were taken from eight dogs with cytological and clinical diagnosis of TVT. To validate the immunochemical results in the primary cell culture of TVT, a chromosome count was performed. For the statistical analysis, the Mann-Whitney test with p<0.05 was used. TVT tissues and culture cells showed intense anti-vimentin immunoreactivity, lightly to moderate immunoreactivity for anti-lysozyme, and mild for anti-alpha-antitrypsin. No marking was achieved for CD3 and CD79α. All culture cells showed chromosomes variable number of 56 to 68. This is the first report on the use of immunocytochemical characterization in cell culture of TVT. Significant statistic difference between immunochemistry in tissue and culture cell was not established, what suggests that the use of this technique may provide greater certainty for the confirmation of tumors in the primary culture. This fact is particularly important because in vitro culture of tumor tissues has been increasingly used to provide quick access to drug efficacy and presents relevant information to identify potential response to anticancer medicine; so it is possible to understand the behavior of the tumor.

Tension-free vaginal tape versus lata fascia sling: The importance of transvulvar ultrasound in the assessment of relevant anatomical parameters in treatment of women with stress urinary incontinence

Directory of Open Access Journals (Sweden)

Frederico Teixeira Brandt

2009-01-01

Full Text Available Objective: To describe the relevance of transvulvar ultrasound in the assessment of anatomical differences induced by the lata fascia sling (LFS and tension-free vaginal tape (TVT procedures. Materials and Methods: Forty women with stress urinary incontinence (SUI, aged 30 to 60 years, have been treated with either LFS (20 patients or TVT (20 patients. The transvulvar ultrasound of the urethrovesical junction (UVJ and proximal urethra (PU has been used as the main investigational tool both pre- and post-operatively. The studied parameters were the vertical (VUVJD and horizontal (HUVJD UVJ distances, the pubourethral distance (PUD and the PU length. Results: The VUVJD did not vary significantly after the LFS surgery (P=0.10. The PUD became shorter (P=0.001 and the HUVJD became shorter only at rest (P=0.03 after the correction by LFS. The TVT procedure has led to shortening of the VUVJ displacement (P=0.0005 and of the PU length (P=0.02. Conclusions: The transvulvar ultrasound was of utmost importance in the demonstration that both the LFS and TVT surgical procedures elongate the PU, even though the LFS technique does it more efficiently. The LFS technique focus more on shortening the PUD and the TVT procedure focus more on the correction of the vertical UVJ displacement.

A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

Science.gov (United States)

Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

2018-01-01

This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

Comparative costs and activity from a sample of UK clinical trials units.

Science.gov (United States)

Hind, Daniel; Reeves, Barnaby C; Bathers, Sarah; Bray, Christopher; Corkhill, Andrea; Hayward, Christopher; Harper, Lynda; Napp, Vicky; Norrie, John; Speed, Chris; Tremain, Liz; Keat, Nicola; Bradburn, Mike

2017-05-02

The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ. Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ�

Postpartum perineal reapir performed by midwives: A randomised trial comparing two suture techniques for perineal repair leaving the skin unsutured

DEFF Research Database (Denmark)

Kindberg, Sara; Misan, Stehouwer; Hvidman, Lone

2008-01-01

Postpartum perineal repair performed by midwives: A randomised trial comparing two suture techniques leaving the skin unsutured. Objective      To compare a continuous suture technique to interrupted stitches using inverted knots for postpartum perineal repair of second-degree lacerations...... and episiotomies.   Design          A double blind randomised controlled trial.   Setting          A Danish university hospital with more than 4800 deliveries annually.   Population   400 healthy primiparous women with a vaginal delivery at term.   Method         Randomisation was computer-controlled. Structured...... healing, patient satisfaction, dyspareunia or need for resuturing. The continuous suture technique was significantly faster (15 min. vs. 17 min, p=0.03) and less suture material was used (1 vs. 2 packets, pskin unsutured...

Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

Science.gov (United States)

Williams, N S; Johnston, D

1980-07-12

Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complications. The mean time spent managing the stoma was 45 +/- SEM 9 min/24 hours during spontaneous action and 53 +/- 9 min/24 hours during irrigation. This difference was not significant. The numbers of bowel actions weekly were 13 +/ SEM 2 during spontaneous action and 6 +/- 1 during irrigation (p Irrigation reduced odour and flatus in 20 patients and enabled 12 out of 18 to stop using drugs and seven to discard their appliance. Irrigation also improved the social life of 18 patients and the working conditions of eight out of 14. These finding show that some patients may not be suitable for irrigation but that for many it is better than the conventional British method of colostomy management. With modern apparatus the technique is safe.

Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

Science.gov (United States)

Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

2018-02-01

OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid use compared with placebo. Postoperative multimodal pain management, including a nonsteroidal antiinflammatory medication, should be considered after surgery to improve patient comfort and to limit opioid use. Clinical trial registration no.: NCT02351700 (clinicaltrials

A multicenter, randomized trial comparing synthetic surfactant with modified bovine surfactant extract in the treatment of neonatal respiratory distress syndrome

NARCIS (Netherlands)

Adams, E; Vollman, J; Giebner, D; Maurer, M; Dreyer, G; Bailey, L; Anderson, M; Mefford, L; Beaumont, E; Sutton, D; Puppala, B; Mangurten, HH; Secrest, J; Lewis, WJ; Carteaux, P; Bednarek, F; Welsberger, S; Gosselin, R; Pantoja, AF; Belenky, A; Campbell, P; Patole, S; Duenas, M; Kelly, M; Alejo, W; Lewallen, P; DeanLieber, S; Hanft, M; Ferlauto, J; Newell, RW; Bagwell, J; Levine, D; Lipp, RW; Harkavy, K; Vasa, R; Birenbaum, H; Broderick, KA; Santos, AQ; Long, BA; Gulrajani, M; Stern, M; Hopgood, G; Hegyi, T; Alba, J; Christmas, L; McQueen, M; Nichols, N; Brown, M; Quissell, BJ; Rusk, C; Marks, K; Gifford, K; Hoehn, G; Pathak, A; Marino, B; Hunt, P; Fox, [No Value; Sharpstein, C; Feldman, B; Johnson, N; Beecham, J; Balcom, R; Helmuth, W; Boylan, D; Frakes, C; Magoon, M; Reese, K; Schwersenski, J; Schutzman, D; Soll, R; Horbar, JD; Leahy, K; Troyer, W; Juzwicki, C; Anderson, P; Dworsky, M; Reynolds, L; Urrutia, J; Gupta, U; Adray, C

Objective. To compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extract (Survanta, Ross Laboratories) in the treatment of neonatal respiratory distress syndrome (RDS). Design. Multicenter, randomized trial. Setting. Thirty-eight

Systematic review and meta-analysis of published randomized controlled trials comparing purse-string vs conventional linear closure of the wound following ileostomy (stoma) closure.

Science.gov (United States)

Sajid, Muhammad Shafique; Bhatti, Muhammad I; Miles, William Fa

2015-05-01

The objective of this article is to systematically analyse the randomized, controlled trials comparing the effectiveness of purse-string closure (PSC) of an ileostomy wound with conventional linear closure (CLC). Randomized, controlled trials comparing the effectiveness of purse-string closure vs conventional linear closure (CLC) of ileostomy wound in patients undergoing ileostomy closure were analysed using RevMan®, and the combined outcomes were expressed as risk ratio (RR) and standardized mean difference (SMD). Three randomized, controlled trials, recruiting 206 patients, were retrieved from medical electronic databases. There were 105 patients in the PSC group and 101 patients in the CLC group. There was no heterogeneity among included trials. Duration of operation (SMD: -0.18; 95% CI: -0.45, 0.09; z = 1.28; P SMD: 0.01; 95% CI: -0.26, 0.28; z = 0.07; P infection (OR, 0.10; 95% CI: 0.03, 0.33; z = 3.78; P infection apparently without influencing the duration of operation and length of hospital stay. © The Author(s) 2014. Published by Oxford University Press and the Digestive Science Publishing Co. Limited.

Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

Directory of Open Access Journals (Sweden)

Joseph S Ross

2009-09-01

Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

Cell proliferation markers in the transplanted canine transmissible venereal tumor

Directory of Open Access Journals (Sweden)

F.G.A. Santos

2011-12-01

Full Text Available Adult male mongrel dogs were subcutaneously transplanted with the canine transmissible venereal tumor (TVT on the hypogastric region. Twelve specimens of tumors were collected, half during the proliferative phase and the other half during the regressive phase. Fragments of the tumor were fixed in 10% buffered formalin and routinely processed for light microscopy. Sections of 4µm were stained by Schorr or AgNOR or either immunostained for MIB1 (Ki67. Schorr stain, AgNOR and MIB1 showed an increased proliferative activity through mitotic index, nuclear argyrophilic protein stain and cycling tumoral cells in the growing tumors, respectively. All of the three cell proliferation markers were able to distinguish the TVT in both evolution phases. MIB1 monoclonal antibody was the best in the morphologic evaluation of growth and regression of TVT. This resulted in higher values than AgNORs counting and mitotic index. MIB1 immunostaining was the most effective parameter of the proliferative activity of TVT. However, a significant correlation has been detected only between mitosis counting and AgNORs.

ANATOMIC PATHOLOGICAL ASPECTS OF CANINE TRANSMISSIBLE VENEREAL TUMOR

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C. Calderon

2016-09-01

Full Text Available Canine transmissible venereal tumor, TVT, is a very common aggressive neoplasm, and the most affected animals are dogs, and other canids may also be affected. There are many forms of transmission, and this naturally occurs between the carriers, sexual intercourse is considered a major route of transmission, it is usually found in urban areas with an environment with a large population of free-roaming dogs and affect dogs and bitches. The TVT can clinically appear macroscopic form with lumps of various sizes, ulcerated, necrotic or not, and its development is usually in the genitals with associated secondary problems, such as urinary retention and others. The tumor diagnosis, in addition to anamnesis should be associated with the cytological or histological analysis. Several techniques are used to collect samples for analysis in microscopy, where the best technique to be used in the diagnosis of TVT is the aspiration cytology. The chemotherapy is considered the most effective method for TVT treatment, and vincristine sulfate is the drug of choice

Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

Science.gov (United States)

Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

2016-12-01

Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those with a baseline VA of 20/50 or worse receiving bevacizumab and laser treatment (mean [SD], -55 [108] µm; 95% CI, -82 to -28 µm; P grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years

Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials.

Science.gov (United States)

Kedhi, Elvin; Stone, Gregg W; Kereiakes, Dean J; Serruys, Patrick W; Parise, Helen; Fahy, Martin; Simonton, Charles A; Sudhir, Krishnankutty; Sood, Poornima; Smits, Pieter C

2012-09-01

Recent studies have suggested that EES may reduce ST compared to PES, but no individual trial has been adequately powered for this endpoint. The incidence of stent thrombosis, as well as the impact of dual antiplatelet therapy (DAPT) discontinuation during the first two years following everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) deployment were therefore analysed from a pooled, patient-level database derived from four randomised clinical trials. Data from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials (n=6,789 patients) were analysed. Two-year ST rates were determined using time-to-event methods and compared with the log-rank test. ST rates were also determined after DAPT discontinuation. EES compared to PES significantly reduced the two-year rates of ST (0.7% versus 2.3%, p=0.0001), including the interval rates of ST up to 30 days (0.2% versus 1.0%, p<0.0001), between 31 days and one year (0.2% versus 0.6%, p=0.02), and after one year (0.3% versus 0.8%, p=0.001). EES also reduced the two-year composite rate of cardiac death or MI (4.0% versus 6.6%, p=0.0001). Increased rates of ST after DAPT discontinuation beyond six months were observed in the PES cohort, but not in the EES cohort. In this large pooled analysis from four randomised trials, treatment with EES compared to PES significantly reduced the rates of ST through two years of follow-up, with a concomitant reduction in cardiac death or MI. DAPT discontinuation beyond six months may be safe with EES.

Rationale for a randomized controlled trial comparing two prophylaxis regimens in adults with severe hemophilia A: the Hemophilia Adult Prophylaxis Trial

Science.gov (United States)

Ragni, Margaret V

2011-01-01

A major goal of comprehensive hemophilia care is to prevent occurrence of bleeds by prophylaxis or regular preventive factor, one or more times weekly. Although prophylaxis is effective in reducing bleeding and joint damage in children, whether it is necessary to continue into adulthood is not known. The purpose of this article is to describe a Phase III randomized controlled trial to evaluate prophylaxis comparing two dose regimens in adults with severe hemophilia A. I hypothesize that adults with mature cartilage and joints are less susceptible to joint bleeds and joint damage, and that once-weekly recombinant factor VIII prophylaxis, with up to two rescue doses per week, is as effective as thrice-weekly prophylaxis in reducing bleeding frequency, but less costly and more acceptable, with higher quality of life. The ultimate goal of this project is to determine whether once-weekly prophylaxis is any worse than thrice-weekly prophylaxis in reducing joint bleeding frequency, while potentially utilizing less factor, at lower cost, leading to a better quality of life. This is an innovative concept, as it challenges the current paradigm of thrice-weekly prophylaxis in adults, which is based on dosing in children. Furthermore, this trial will assess interdose thrombin generation, a novel tissue factor-based assay of hemostasis, to determine if individualized thrombin generation can predict more individualized prophylaxis dosing, which would be practice changing. PMID:21939418

Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials.

Science.gov (United States)

Edwards, Meghan K; Loprinzi, Paul D

2018-03-01

No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.

Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis

Directory of Open Access Journals (Sweden)

van Eijk RPA

2018-03-01

Full Text Available Ruben PA van Eijk,1 Marinus JC Eijkemans,2 Dimitris Rizopoulos,3 Leonard H van den Berg,4,* Stavros Nikolakopoulos5,* 1Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 2Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands; 3Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands; 4Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 5Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands *These authors contributed equally to this work Objective: Amyotrophic lateral sclerosis (ALS clinical trials based on single end points only partially capture the full treatment effect when both function and mortality are affected, and may falsely dismiss efficacious drugs as futile. We aimed to investigate the statistical properties of several strategies for the simultaneous analysis of function and mortality in ALS clinical trials. Methods: Based on the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT database, we simulated longitudinal patterns of functional decline, defined by the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R and conditional survival time. Different treatment scenarios with varying effect sizes were simulated with follow-up ranging from 12 to 18 months. We considered the following analytical strategies: 1 Cox model; 2 linear mixed effects (LME model; 3 omnibus test based on Cox and LME models; 4 composite time-to-6-point decrease or death; 5 combined assessment of function and survival (CAFS; and 6 test based on joint modeling framework. For each analytical strategy, we calculated the empirical power and sample size. Results: Both Cox and LME models have increased false-negative rates when treatment exclusively affects either function or survival. The joint model has superior power compared to other strategies. The composite end point

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

Science.gov (United States)

Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

2017-12-01

Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

Directory of Open Access Journals (Sweden)

Gray Janine C

2012-08-01

Full Text Available Abstract Background According to the UK Adult Dental Health Survey (2009 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. Methods/Design IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone. Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period. Patients will then wear each set of dentures for a period of 8 weeks (in random order during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period. Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference and confirmation period (adjusted denture preference. A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300. Discussion

A multi-professional software tool for radiation therapy treatment verification

International Nuclear Information System (INIS)

Fox, Tim; Brooks, Ken; Davis, Larry

1996-01-01

Purpose: Verification of patient setup is important in conformal therapy because it provides a means of quality assurance for treatment delivery. Electronic portal imaging systems have led to software tools for performing digital comparison and verification of patient setup. However, these software tools are typically designed from a radiation oncologist's perspective even though treatment verification is a team effort involving oncologists, physicists, and therapists. A new software tool, Treatment Verification Tool (TVT), has been developed as an interactive, multi-professional application for reviewing and verifying treatment plan setup using conventional personal computers. This study will describe our approach to electronic treatment verification and demonstrate the features of TVT. Methods and Materials: TVT is an object-oriented software tool written in C++ using the PC-based Windows NT environment. The software utilizes the selection of a patient's images from a database. The software is also developed as a single window interface to reduce the amount of windows presented to the user. However, the user can select from four different possible views of the patient data. One of the views is side-by-side comparison of portal images (on-line portal images or digitized port film) with a prescription image (digitized simulator film or digitally reconstructed radiograph), and another view is a textual summary of the grades of each portal image. The grades of a portal image are assigned by a radiation oncologist using an evaluation method, and the physicists and therapists may only review these results. All users of TVT can perform image enhancement processes, measure distances, and perform semi-automated registration methods. An electronic dialogue can be established through a set of annotations and notes among the radiation oncologists and the technical staff. Results: Features of TVT include: 1) side-by-side comparison of portal images and a prescription image; 2

Randomized Trials Comparing Inactivated Vaccine after Medium- or High-titer Measles Vaccine with Standard Titer Measles Vaccine after Inactivated Vaccine

DEFF Research Database (Denmark)

Aaby, Peter; Ravn, Henrik; Benn, Christine S.

2016-01-01

Background: Observational studies have suggested that girls have higher mortality if their most recent immunization is an inactivated vaccine rather than a live vaccine. We therefore reanalyzed 5 randomized trials of early measles vaccine (MV) in which it was possible to compare an inactivated va...

Outcomes of the Smoker's Health Project: A Pragmatic Comparative Effectiveness Trial of Tobacco-Dependence Interventions Based on Self-Determination Theory

Science.gov (United States)

Williams, Geoffrey C.; Niemiec, Christopher P.; Patrick, Heather; Ryan, Richard M.; Deci, Edward L.

2016-01-01

A pragmatic comparative effectiveness trial examined whether extending the duration of a cost-effective, intensive tobacco-dependence intervention designed to support autonomy will facilitate long-term tobacco abstinence. Participants were randomly assigned to one of three tobacco-dependence interventions based on self-determination theory,…

A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.

Science.gov (United States)

Eswaran, Shanti L; Chey, William D; Han-Markey, Theresa; Ball, Sarah; Jackson, Kenya

2016-12-01

There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients. This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires. After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating

Comparing abrupt and gradual smoking cessation: a randomized trial.

Science.gov (United States)

Etter, Jean-François

2011-11-01

To compare abrupt and gradual smoking cessation. Randomized trial and observational study, Internet, 2007-2010. Smokers with no strong preference for abrupt or gradual quitting were randomly assigned to quitting immediately (n=472), or to gradually reducing their cigarette consumption over 2 weeks and then quit (n=502). Smokers who strongly preferred to quit abruptly were instructed to do so immediately (n=2456), those who strongly preferred gradual were instructed to reduce their cigarette consumption over 2 weeks, then quit (n=1801). Follow-up was conducted 4 weeks after target quit dates. Those who preferred abrupt quitting were the most motivated to quit and the most confident in their ability to quit. At follow-up, quit rates were 16% in those who preferred abrupt cessation, 7% in those who preferred gradual cessation and 9% in those who had no preference (pmotivation to quit and confidence in ability to quit: those who had low levels of motivation or low levels of confidence were more likely to quit at follow-up if they preferred and used abrupt rather than gradual. In those who had no strong preference for either method, abrupt and gradual produced similar results. Those who preferred and used the abrupt method were more likely to quit than those who preferred and used the gradual method, in particular when they had low motivation and confidence. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Cost Analyses in the US and Japan: A Cross-Country Comparative Analysis Applied to the PRONOUNCE Trial in Non-Squamous Non-Small Cell Lung Cancer.

Science.gov (United States)

Hess, Lisa M; Rajan, Narayan; Winfree, Katherine; Davey, Peter; Ball, Mark; Knox, Hediyyih; Graham, Christopher

2015-12-01

Health technology assessment is not required for regulatory submission or approval in either the United States (US) or Japan. This study was designed as a cross-country evaluation of cost analyses conducted in the US and Japan based on the PRONOUNCE phase III lung cancer trial, which compared pemetrexed plus carboplatin followed by pemetrexed (PemC) versus paclitaxel plus carboplatin plus bevacizumab followed by bevacizumab (PCB). Two cost analyses were conducted in accordance with International Society For Pharmacoeconomics and Outcomes Research good research practice standards. Costs were obtained based on local pricing structures; outcomes were considered equivalent based on the PRONOUNCE trial results. Other inputs were included from the trial data (e.g., toxicity rates) or from local practice sources (e.g., toxicity management). The models were compared across key input and transferability factors. Despite differences in local input data, both models demonstrated a similar direction, with the cost of PemC being consistently lower than the cost of PCB. The variation in individual input parameters did affect some of the specific categories, such as toxicity, and impacted sensitivity analyses, with the cost differential between comparators being greater in Japan than in the US. When economic models are based on clinical trial data, many inputs and outcomes are held consistent. The alterable inputs were not in and of themselves large enough to significantly impact the results between countries, which were directionally consistent with greater variation seen in sensitivity analyses. The factors that vary across jurisdictions, even when minor, can have an impact on trial-based economic analyses. Eli Lilly and Company.

The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol

Directory of Open Access Journals (Sweden)

Ford Daniel E

2010-11-01

Full Text Available Abstract Background Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group. Methods The informatics system will be evaluated in a comparative effectiveness trial of 160 community-based primary care practices, cluster-randomized at the practice level. In the QUIT-PRIMO intervention, patients will be provided a paper information-prescription referral and then "e-referred" to the system. In the comparison group, patients will receive only the paper-based information-prescription referral with the website address. Once patients go to the website, they are subsequently randomized within practices to either a standard patient smoking cessation website or an augmented version with access to a tobacco treatment specialist online, motivational emails, and an online support group. We will compare intervention and control practice participation (referral rates and patient participation (proportion referred who go to the website. We will then compare the effectiveness of the standard and augmented patient websites. Discussion Our goal is to evaluate an integrated informatics solution to increase access to web-delivered smoking cessation support. We will analyze the impact of this integrated system in terms of process (provider e-referral and patient login and patient outcomes (six-month smoking cessation. Trial Registration Web-delivered Provider Intervention for

Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

Science.gov (United States)

Zeng, Yuxiao; Zhang, Xuecheng; Zhou, Jing; Wang, Xinwei; Jiao, Ruimin; Liu, Zhishun

2018-05-01

To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation. Individuals with functional constipation will be randomly allocated to receive either EA or TENS (n = 51, each), 3 times per week for 8 weeks. The primary outcome is the percentage of participants with an average increase from baseline of 1 or more complete spontaneous bowel movements at week 8. The secondary outcome measures are the following: at the time of visits, changes in the number of complete spontaneous bowel movements, number of spontaneous bowel movements, stool character, difficulty in defecation, patients' assessment of quality of life regarding constipation (self-report questionnaire), and use of auxiliary defecation methods. The results of this trial should verify whether EA is more efficacious than TENS for relieving symptoms of functional constipation. The major limitation of the study is the lack of blinding of the participants and acupuncturist.

Intermediate term evaluation of tension-free vaginal tape outcome: Patient's perspective

International Nuclear Information System (INIS)

Farrukh, A.; Doyle, P.M.

2006-01-01

Various new sling techniques for surgical treatment of female urinary stress incontinence have evolved over the last decade and several reports indicate high objective cure rates and fewer complications compared to traditional major procedures. We conducted a study to determine the subjective outcome and satisfaction from a patient's perspective, based on their own responses to a symptom-specific health related postal questionnaire after five year five years of having Tension-free vaginal tape surgery (TVT, Gynecare, UK). Data were collected from 70 women. The end-point was improvement or cure from stress incontinence and its affect on their disease related quality of life. A significant improvement in continence was reported by 80 percent of treated women. The responses also allowed these women to appreciate the difference TVT had made on their daily activities with a definite positive impact on quality of life. (author)

Comparative effectiveness of family problem-solving therapy (F-PST for adolescents after traumatic brain injury: Protocol for a randomized, multicenter, clinical trial

Directory of Open Access Journals (Sweden)

Brad G. Kurowski

2018-06-01

Full Text Available Introduction: The objective of this manuscript is to describe the methodology that will be used to test the comparative effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST for improving functional outcomes of complicated mild to severe adolescent TBI. Methods: Three-arm comparative effectiveness, randomized clinical trial (RCT design. We describe the protocol of a three-arm RCT comparing the effectiveness of three modalities of F-PST to reduce executive dysfunction and behavior problems following TBI in adolescence. The RCT will compare the relative effectiveness among face-to-face; online and self-directed; and therapist-supported online modes of treatment. Ethics and dissemination: It is anticipated that findings from this work will inform future clinical care practices, with implications for treatment of other patient populations of youth with psychological symptoms arising from neurological conditions. Institutional review board approval will be obtained from all sites prior to commencement of the study. Clinical Trials Registration: NCT:02368366, Keywords: Pediatric traumatic brain injury, Telehealth, Problem solving, Behavior, Executive function

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

Science.gov (United States)

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

Science.gov (United States)

Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

2017-01-01

The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

Science.gov (United States)

Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

2017-01-01

Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

Ten year results of a randomised trial comparing two conservative treatment strategies for small size breast cancer

International Nuclear Information System (INIS)

Mariani, L.; Salvadori, B.; Marubini, E.; Conti, A.R.; Rovini, D.; Cusumano, F.; Rosolin, T.; Andreola, S.; Zucali, R.; Rilke, F.; Veronesi, U.

1998-01-01

We report the 10-year results of a randomised clinical trial in which two different breast conservation treatment strategies were compared in women with small, non-metastatic primary breast cancer: quadrantectomy, axillary dissection and radiotherapy (QUART) versus tumorectomy and axillary dissection followed by external radiotherapy and a boost with 192 Ir implantation (TART). No second surgery was given to women with affected surgical margins. Axillary node positive women received adjuvant medical therapy. From 1985-1987, this trial accrued 705 patients, 360 in the QUART and 345 in the TART arm. Crude cumulative incidence curves for intrabreast tumour recurrence (IBTR) and metastases as first events and mortality curves in each of the two treatment arms were computed. A crude cumulative incidence curve of IBTR as a second event (in women who had already had a local recurrence) was also computed. The two groups were compared in terms of hazard for IBTR, metastases or death occurrence by using Cox regression models, both with and without adjustment for patient age, tumour size, number of metastatic axillary nodes and histology. Possible interactions between the aforementioned prognostic factors and the type of surgery were also investigated. The two groups were well matched for baseline patient and tumour characteristics, the only exception being resection margins, which were more often positive in the TART group. At the Cox model, a significant difference between groups was detected for IBTR (P<0.0001), but not for distant metastases and overall survival. In particular, 5- and 10-year estimates of crude cumulative incidence of IBTR were 4.7 and 7.4% in the QUART group, and 11.6 and 18.6% in the TART group. The difference was not substantially affected by patient or disease characteristics. Likewise, the status of resection margins in women who underwent TART treatment did not significantly influence the risk of occurrence of IBTRs. Finally, the rate of second IBTR

Letrozole compared with tamoxifen for elderly patients with endocrine-responsive early breast cancer: the BIG 1-98 trial

DEFF Research Database (Denmark)

Crivellari, D.; Sun, Z.; Coates, A.S.

2008-01-01

PURPOSE: To explore potential differences in efficacy, treatment completion, and adverse events (AEs) in elderly women receiving adjuvant tamoxifen or letrozole for five years in the Breast International Group (BIG) 1-98 trial. METHODS: This report includes the 4,922 patients allocated to 5 years...... of letrozole or tamoxifen in the BIG 1-98 trial. The median follow-up was 40.4 months. Subpopulation Treatment Effect Pattern Plot (STEPP) analysis was used to examine the patterns of differences in disease-free survival and incidences of AEs according to age. In addition, three categoric age groups were...... had superior efficacy (DFS) compared with tamoxifen in all age groups. On the basis of a small number of patients older than 75 years (6%), age per se should not unduly affect the choice of adjuvant endocrine therapy Udgivelsesdato: 2008/4/20...

A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

Science.gov (United States)

2015-10-01

score >45. Exclusion criteria: Service related trauma within last 3 months, history of schizophrenia, bipolar disorder , dementia, moderate or severe...7.7% 0.0% 8.3% 0.191 Bipolar disorder , % 7.7% 10.3% 13.9% 0.681 Substance use disorder , % 30.8% 43.6% 41.7% 0.458 Major depressive disorder ...Award Number: W81XWH-12-1-0576 TITLE: A Randomized, Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in

Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

Science.gov (United States)

Pagnoux, Christian; Carette, Simon; Khalidi, Nader A.; Walsh, Michael; Hiemstra, Thomas F.; Cuthbertson, David; Langford, Carol; Hoffman, Gary S.; Koening, Curry L.; Monach, Paul A.; Moreland, Larry; Mouthon, Luc; Seo, Phil; Specks, Ulrich; Ytterberg, Steven; Westman, Kerstin; Hoglund, Peter; Harper, Lorraine; Flossmann, Oliver; Luqmani, Raashid; Savage, Caroline; Rasmussen, Niels; de Groot, Kirstin; Tesar, Vladimir; Jayne, David; Merkel, Pater A.; Guillevin, Loic

2015-01-01

Objective To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods The main characteristics and outcomes of patients with generalised and/or severe GPA or MPA with a five-factor score ≥1 enrolled in the French Vasculitis Study Group (FVSG) or the US-Canadian-based Vasculitis Clinical Research Consortium cohorts were compared to those enrolled in one of 2 FVSG clinical RCTs (WEG91, WEGENT) or 3 European Vasculitis Society clinical trials (CYCLOPS, CYCAZAREM, IMPROVE). Results 657 patients (65.3% with GPA) in RCTs were compared to 437 in cohorts (90.6% with GPA). RCT patients were older at diagnosis than the cohort patients (56.6±13.9 vs. 46.8±17.3 years), had higher Birmingham vasculitis activity score (19.5±9.1 vs. 16.9±7.4), and more frequent kidney disease (84.0% vs. 54.9%) but fewer ear, nose, and throat symptoms (56.8% vs. 72.2%). At 56 months post-diagnosis, mortality and relapse rates, adjusted for age and renal function, were higher for patients with GPA in RCTs vs. cohorts (10.7% vs. 2.5% [p=0.001] and 22.5% vs. 15.6% [p=0.03], respectively) but similar for patients with MPA (6.2% vs. 6.6% [p=0.92] and 16.6% vs. 10.1% [p=0.39], respectively). Conclusion Patients with GPA or MPA in RCTs and those in observational cohorts show important differences that should be remembered when interpreting results based on these study populations. PMID:26016754

Population-based versus practice-based recall for childhood immunizations: a randomized controlled comparative effectiveness trial.

Science.gov (United States)

Kempe, Allison; Saville, Alison; Dickinson, L Miriam; Eisert, Sheri; Reynolds, Joni; Herrero, Diana; Beaty, Brenda; Albright, Karen; Dibert, Eva; Koehler, Vicky; Lockhart, Steven; Calonge, Ned

2013-06-01

We compared the effectiveness and cost-effectiveness of population-based recall (Pop-recall) versus practice-based recall (PCP-recall) at increasing immunizations among preschool children. This cluster-randomized trial involved children aged 19 to 35 months needing immunizations in 8 rural and 6 urban Colorado counties. In Pop-recall counties, recall was conducted centrally using the Colorado Immunization Information System (CIIS). In PCP-recall counties, practices were invited to attend webinar training using CIIS and offered financial support for mailings. The percentage of up-to-date (UTD) and vaccine documentation were compared 6 months after recall. A mixed-effects model assessed the association between intervention and whether a child became UTD. Ten of 195 practices (5%) implemented recall in PCP-recall counties. Among children needing immunizations, 18.7% became UTD in Pop-recall versus 12.8% in PCP-recall counties (P immunization rates in preschool children.

Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

Science.gov (United States)

Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

2015-04-15

Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

Science.gov (United States)

Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

2016-01-01

Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice.

Science.gov (United States)

Brænd, Anja Maria; Straand, Jørund; Jakobsen, Rune Bruhn; Klovning, Atle

2016-04-11

Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998-2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Cohort study of trials with systematic searches for published results. Clinical drug trials in Norwegian general practice. We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ(2) test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

The effectiveness of neuro-music therapy according to the Heidelberg model compared to a single session of educational counseling as treatment for tinnitus: a controlled trial.

Science.gov (United States)

Argstatter, Heike; Grapp, Miriam; Hutter, Elisabeth; Plinkert, Peter K; Bolay, Hans-Volker

2015-03-01

Tinnitus is a very common symptom, yet the quest for an effective treatment is challenging. Results from several clinical trials support the notion that neuro-music therapy is an effective means to reduce tinnitus distress with short duration and long lasting effect. However, until now, the effectiveness has not been tested in a controlled trial against an active comparator. The trial was designed as two-center, parallel intervention group controlled study with two intervention groups: Counseling (50minute individualized personal instruction) or neuro-music therapy (counseling plus eight 50-minute sessions of individualized music therapy). Data of n=290 patients suffering from chronic tinnitus were analyzed. Outcome measure was the change in Tinnitus Questionnaire Total Scores (TQ) from baseline (admission) to end of treatment. Both treatment groups achieved a statistically relevant reduction in TQ scores, though 66% of patients in the music therapy group attained a clinically meaningful improvement compared to 33% in the counseling group. A binary logistic regression revealed two variables significantly influencing therapy outcome: initial tinnitus score and type of therapy with an OR for the music therapy compared to the counseling of 4.34 (CI 2.33-8.09). Counseling is an appropriate treatment option with well above chance of improvement. The neuro-music therapy outperformed the counseling. This treatment targets the tinnitus sound itself, is short in duration, intrinsically motivating and easy to operate and thus presents a possible complement to the therapeutic spectrum in chronic tinnitus. The trial was registered at the ClinicalTrials.gov registry (ID: NCT01845155). Copyright © 2014 Elsevier Inc. All rights reserved.

FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups.

Science.gov (United States)

Howard, Courtney; Rose, Caren Lee; Trouton, Konia; Stamm, Holly; Marentette, Danielle; Kirkpatrick, Nicole; Karalic, Sanja; Fernandez, Renee; Paget, Julie

2011-06-01

To determine whether menstrual cups are a viable alternative to tampons. Randomized controlled trial. Prince George, Victoria, and Vancouver, BC. A total of 110 women aged 19 to 40 years who had previously used tampons as their main method of menstrual management. Participants were randomized into 2 groups, a tampon group and a menstrual cup group. Using online diaries, participants tracked 1 menstrual cycle using their regular method and 3 menstrual cycles using the method of their allocated group. Overall satisfaction; secondary outcomes included discomfort, urovaginal infection, cost, and waste. Forty-seven women in each group completed the final survey, 5 of whom were subsequently excluded from analysis (3 from the tampon group and 2 from the menstrual cup group). Overall satisfaction on a 7-point Likert scale was higher for the menstrual cup group than for the tampon group (mean [standard deviation] score 5.4 [1.5] vs 5.0 [1.0], respectively; P=.04). Approximately 91% of women in the menstrual cup group said they would continue to use the cup and recommend it to others. Women used a median of 13 menstrual products per cycle, or 169 products per year, which corresponds to approximately 771,248,400 products used annually in Canada. Estimated cost for tampon use was $37.44 a year (similar to the retail cost of 1 menstrual cup). Subjective vaginal discomfort was initially higher in the menstrual cup group, but the discomfort decreased with continued use. There was no significant difference in physician-diagnosed urovaginal symptoms between the 2 groups. Both of the menstrual management methods evaluated were well tolerated by subjects. Menstrual cups are a satisfactory alternative to tampons and have the potential to be a sustainable solution to menstrual management, with moderate cost savings and much-reduced environmental effects compared with tampons. Trial registration number C06-0478 (ClinicalTrials.gov).

Effect of race/ethnicity on participation in HIV vaccine trials and comparison to other trials of biomedical prevention.

Science.gov (United States)

Dhalla, Shayesta; Poole, Gary

2014-01-01

Racial/ethnic minorities are underrepresented in actual HIV vaccine trials in North America, and willingness to participate (WTP) and retention in an HIV vaccine trial may differ from that in Whites. In this review, the authors identified HIV vaccine preparedness studies (VPS) in North America in high-risk populations that examined the relationship between race/ethnicity and WTP in a preventive phase 3 HIV vaccine trial, and the relationship to retention. Studies were categorized by risk group, and comparison group (Whites vs. non-Whites). Other types of trials of biomedical prevention were also identified, and WTP and retention rates were compared and contrasted to actual HIV vaccine trials. In the studies identified, WTP in a hypothetical trial HIV vaccine trial did not differ by race/ethnicity. In contrast, actual HIV vaccine trials, an HIV acquisition trial, and a phase 2B preexposure prophylaxis (PrEP) trial have enrolled a large percentage of White men. Human papilloma virus (HPV) privately-funded trials have also enrolled a large number of Whites, due to convenience sampling. Retention in the HIV acquisition trial was lower in African-Americans compared with Whites. Strategies to increase WTP and enhanced retention (ER) strategies may help in recruiting and retaining minority participants in actual HIV vaccine trials and other trials of biomedical prevention.

INTRAOCULAR TRANSMISSIBLE VENEREAL TUMOR IN A DOG TUMOR VENÉREO TRANSMISSÍVEL INTRA-OCULAR EM CÃO

Directory of Open Access Journals (Sweden)

Geórgia Nadalini Rodrigues

2001-02-01

Full Text Available Canine transmissible venereal tumor (TVT is a round cell neoplasm occurring on the external genital mucosa of male and female dogs. Transmission is by cell implantation during coitus, licking, or other interaction between an affected dog and a susceptible host. Metastasis of the tumor rarely occurs. This report describes an unusual presentation of TVT with intraocular involvement and inguinal lymph nodes metastasis. The subject was a six-year-old, intact, male, Brazilian Terrier dog with a history of abnormal masses in the right eye, penis and several subcutaneous nodules in the inguinal area. Histopathological examination of the eye specimens as well as cytologic examination of penile mass and subcutaneous nodules revealed similar findings. The examination revealed round cells containing a large nuclei with prominent, central located nucleoli and a pale cytoplasm containing few small, clear round vacuoles. Histologically, the subcutaneous nodules in the inguinal area were lymph nodes. The diagnosis of TVT with intraocular involvement and lymph nodes metastasis was based on clinical, cytologic and histopathologic findings.Tumor venéreo transmissível (TVT é uma neoplasia de células redondas que acomete a mucosa genital externa de cães, machos e fêmeas. A transmissão decorre da implantação de células tumorais durante o coito, brigas ou interações entre animais portadores e susceptíveis. Existem relatos referindo-se a localizações atípicas do TVT, mas metástases raramente ocorrem. O presente relato descreve um caso incomum de TVT, com acometimento intra-ocular e metástases nos linfonodos ingüinais, num cão Terrier Brasileiro, com seis anos de idade. O animal apresentava massas anormais de tecido no olho direito, extremidade do pênis e aumento de volume de linfonodos da região ingüinal. A histopatologia do globo ocular e as citologias da massa peniana e dos nódulos subcutâneos evidenciaram aspectos citológicos semelhantes

Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis.

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Thariani, Rahber; Henry, Norah Lynn; Ramsey, Scott D; Blough, David K; Barlow, Bill; Gralow, Julie R; Veenstra, David L

2013-05-01

Breast cancer tumor markers are used by some clinicians to screen for disease recurrence risk. Since there is limited evidence of benefit, additional research may be warranted. To assess the potential value of a randomized clinical trial of breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors. We developed a decision-analytic model of tumor marker testing plus standard surveillance every 3-6 months for 5 years. The expected value of sample information was calculated using probabilistic simulations and was a function of: the probability of selecting the optimal monitoring strategy with current versus future information; the impact of choosing the nonoptimal strategy; and the size of the population affected. The value of information for a randomized clinical trial involving 9000 women was US$214 million compared with a cost of US$30-60 million to conduct such a trial. The probability of making an alternate, nonoptimal decision and choosing testing versus no testing was 32% with current versus future information from the trial. The impact of a nonoptimal decision was US$2150 and size of population impacted over 10 years was 308,000. The value of improved information on overall survival was US$105 million, quality of life US$37 million and test performance US$71 million. Conducting a randomized clinical trial of breast cancer tumor markers appears to offer a good societal return on investment. Retrospective analyses to assess test performance and evaluation of patient quality of life using tumor markers may also offer valuable areas of research. However, alternative investments may offer even better returns in investments and, as such, the trial concept deserves further study as part of an overall research-portfolio evaluation.

Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

NARCIS (Netherlands)

de Jong, Leo; Lafuma, Antoine; Aguadé, Anne-Sophie; Berdeaux, Gilles

2011-01-01

This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS

Tolerability and efficacy of paliperidone ER compared to olanzapine in the treatment of schizophrenia: A randomized, double-blind, multicentric trial

Directory of Open Access Journals (Sweden)

Sandip Shah

2011-01-01

Full Text Available Background: Paliperidone is an active metabolite of risperidone and actss through a combination of central dopamine Type 2 (D2 and serotonin Type 2 (5HT2A receptor antagonism. Aim: The present randomized, double-blind, multicentric trial was designed to determine the safety and efficacy of paliperidone extended release (ER compared to olanzapine in the treatment of acute schizophrenia. Materials and Methods: A total of 214 patients with diagnosis of schizophrenia were randomized to paliperidone ER (n=109 and olanzapine (n=106 treatment groups. Totally 206 patients were evaluated for efficacy parameters using Positive and negative syndrome scale (PANSS score and Clinical Global Impression-severity of illness (CGI-S and Clinical Global Impression-improvement of illness (CGI-I scales. Safety was assessed by treatment-emergent adverse events and movement disorders. Results: All patients showed significant reduction in PANSS scores at the end of treatment. However, the results were comparable and there was no significant difference at the end of the trial between paliperidone ER group and olanzapine group. Both the treatment groups showed decrease in the severity of illness and improvement in symptomatology. The most common adverse events reported in paliperidone ER versus olanzapine group were Extra Pyramidal Syndrome (EPS (13.7% vs. 15.6%, headache (12.7% vs. 8.9%, increased appetite (8.8% vs. 10.0% and drowsiness (4.9% vs. 303%. There was no clinically relevant difference in change from baseline to the end of the trial in abnormal involuntary movement scale (AIMS and barnes akathisia rating scale (BARS total scores between both the groups. Conclusion: Paliperidone ER is effective in controlling schizophrenic symptoms as well as exhibits comparable tolerability profile. Thus, paliperidone ER has the potential to be a useful new treatment option for patients with schizophrenia.

Interaction Between 2 Nutraceutical Treatments and Host Immune Status in the Pediatric Critical Illness Stress-Induced Immune Suppression Comparative Effectiveness Trial.

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Carcillo, Joseph A; Dean, J Michael; Holubkov, Richard; Berger, John; Meert, Kathleen L; Anand, Kanwaljeet J S; Zimmerman, Jerry J; Newth, Christopher J L; Harrison, Rick; Burr, Jeri; Willson, Douglas F; Nicholson, Carol; Bell, Michael J; Berg, Robert A; Shanley, Thomas P; Heidemann, Sabrina M; Dalton, Heidi; Jenkins, Tammara L; Doctor, Allan; Webster, Angie; Tamburro, Robert F

2017-11-01

The pediatric Critical Illness Stress-induced Immune Suppression (CRISIS) trial compared the effectiveness of 2 nutraceutical supplementation strategies and found no difference in the development of nosocomial infection and sepsis in the overall population. We performed an exploratory post hoc analysis of interaction between nutraceutical treatments and host immune status related to the development of nosocomial infection/sepsis. Children from the CRISIS trial were analyzed according to 3 admission immune status categories marked by decreasing immune competence: immune competent without lymphopenia, immune competent with lymphopenia, and previously immunocompromised. The comparative effectiveness of the 2 treatments was analyzed for interaction with immune status category. There were 134 immune-competent children without lymphopenia, 79 previously immune-competent children with lymphopenia, and 27 immunocompromised children who received 1 of the 2 treatments. A significant interaction was found between treatment arms and immune status on the time to development of nosocomial infection and sepsis ( P patient characteristic.

Meta-analysis of randomized, controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis.

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Tey, Hong Liang; Tan, Andy Soon Leong; Chan, Yuin Chew

2011-04-01

Griseofulvin has been the standard treatment for tinea capitis but newer antifungal agents, particularly terbinafine, are increasingly being used because of their shorter duration of treatment and more consistent absorption rates. We sought to compare the efficacy of oral griseofulvin and oral terbinafine in the treatment of tinea capitis. A search of MEDLINE, EMBASE, Cochrane Central Register of Clinical Trials, and the Cochrane Skin Group Ongoing Skin Trials Register was performed up to January 2010 for randomized controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis in immunocompetent patients. The primary outcome measure was the complete cure rate. The mycological and clinical cure rates and adverse effects were secondary outcome measures. Pooling of treatment effect was accomplished using a random effects model and the I(2) test was used to check for heterogeneity among the studies. Seven studies involving 2163 subjects were included. There was no significant difference in efficacy between griseofulvin (mean duration of treatment 8 weeks, range 6-12 weeks) and terbinafine (mean duration of treatment 4 weeks, range 2-6 weeks); odds ratio = 1.22 favoring terbinafine (95% confidence interval [CI] = 0.785-1.919; P = .37). In the pooled analysis of 5 studies in which Trichophyton species were the predominant (≥65%) pathogenic dermatophyte, terbinafine showed a trend toward greater efficacy (odds ratio 1.49; 95% CI = 0.975-2.277; P = .065). Subgroup analysis revealed that terbinafine was more efficacious than griseofulvin in treating Trichophyton species (1.616; 95% CI = 1.274-2.051; P terbinafine in treating Microsporum species (0.408; 95% CI = 0.254-0.656; P terbinafine demonstrated good safety profiles in the studies. Data on efficacy of griseofulvin and terbinafine for separate groups of Trichophyton and Microsporum species were not available from every study. In the subgroup analysis of Microsporum species, data from only

A Crossover Design for Comparative Efficacy: A 36-Week Randomized Trial of Bevacizumab and Ranibizumab for Diabetic Macular Edema.

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Wiley, Henry E; Thompson, Darby J S; Bailey, Clare; Chew, Emily Y; Cukras, Catherine A; Jaffe, Glenn J; Lee, Richard W J; Loken, Erin K; Meyerle, Catherine B; Wong, Wai; Ferris, Frederick L

2016-04-01

To investigate the comparative efficacy of bevacizumab (Avastin) and ranibizumab (Lucentis; both Genentech, Inc, South San Francisco, CA) for diabetic macular edema (DME) using a crossover study design. Randomized, double-masked, 36-week, 3-period crossover clinical trial. Fifty-six subjects with DME involving the center of the macula in one or both eyes. Monthly intravitreous injections of bevacizumab (1.25 mg) or ranibizumab (0.3 mg). Comparison of mean changes in visual acuity and central retinal thickness, tested using a linear mixed-effects model. Based on the linear mixed-effects model, the 3-month estimated mean improvement in visual acuity was 5.3 letters for bevacizumab and 6.6 letters for ranibizumab (difference, 1.3 letters; P = 0.039). Estimated change in optical coherence tomography (OCT) central subfield mean thickness (CSMT) was -89 μm for bevacizumab and -137 μm for ranibizumab (difference, 48 μm; P < 0.001). Incorporating cumulative treatment benefit, the model yielded a predicted 36-week (9-month) average improvement in visual acuity of 7.1 letters (95% confidence interval [CI], 5.0-9.2) for bevacizumab and 8.4 letters (95% CI, 6.3-10.5) for ranibizumab, and a change in OCT CSMT of -128 μm (95% CI, -155 to -100) for bevacizumab and -176 μm (95% CI, -202 to -149) for ranibizumab. There was no significant treatment-by-period interaction (i.e., treatment difference was constant in all 3 periods), nor was there a significant differential carryover effect from one period to the next. This trial demonstrated a statistically significant but small relative clinical benefit of ranibizumab compared with bevacizumab for treatment of DME, using a markedly reduced sample size relative to a full comparative efficacy study. The effects on visual acuity and central retinal thickness for the 2 drugs are consistent with those reported at 1 year for the concurrent parallel-group trial by the Diabetic Retinopathy Clinical Research Network testing bevacizumab

A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

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Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

2016-06-01

The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

"I was a little surprised": Qualitative Insights from Patients Enrolled in a 12-Month Trial Comparing Opioids to Non-Opioid Medications for Chronic Musculoskeletal Pain.

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Marianne S Matthias; Donaldson, Melvin T; Jensen, Agnes C; Krebs, Erin E

2018-04-28

Chronic musculoskeletal pain is a major public health problem. Although opioid prescribing for chronic pain has increased dramatically since the 1990s, this practice has come under scrutiny because of increases in opioid-related harms and lack of evidence for long-term effectiveness. The Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial was a pragmatic 12-month randomized trial comparing benefits and harms of opioid versus non-opioid medications for chronic musculoskeletal pain. The current qualitative study was designed to better understand trial results by exploring patients' experiences, including perceptions of medications, experiences with the intervention, and whether expectations were met. Thirty-four participants who were purposefully sampled based on treatment group and intervention response participated in semi-structured interviews. The constant comparison method guided analysis. Results revealed that participants often held strong beliefs about opioid medications, which sometimes changed during the trial as they gained experience with medications; participants described a wide variety of experiences with treatment effectiveness, regardless of study group or their response to the intervention; and participants highly valued the personalized pain care model used in SPACE. SPACE trial results indicated no advantage for opioid over non-opioid medications. Qualitative findings suggest that, for patients in both treatment groups, pre-existing expectations of medications and of anticipated improvement in pain shaped experiences with and responses to medications. In addition, the personalized pain care model was described as contributing to positive outcomes in both groups. Copyright © 2018. Published by Elsevier Inc.

A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

DEFF Research Database (Denmark)

Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R

2015-01-01

OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

Massed versus Spaced Practice in Vocology: Effect of a Short-Term Intensive Voice Training versus a Longer-Term Traditional Voice Training

Science.gov (United States)

Meerschman, Iris; Van Lierde, Kristiane; Van Puyvelde, Caro; Bostyn, Astrid; Claeys, Sofie; D'haeseleer, Evelien

2018-01-01

Background: In contrast with most medical and pharmaceutical therapies, the optimal dosage for voice therapy or training is unknown. Aims: The aim of this study was to compare the effect of a short-term intensive voice training (IVT) with a longer-term traditional voice training (TVT) on the vocal quality and vocal capacities of vocally healthy…

Recruitment to publicly funded trials--are surgical trials really different?

Science.gov (United States)

Cook, Jonathan A; Ramsay, Craig R; Norrie, John

2008-09-01

Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB)

Science.gov (United States)

2010-01-01

Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640 PMID:20515467

A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol The comparative rehydration in bronchiolitis study (CRIB

Directory of Open Access Journals (Sweden)

Borland Meredith

2010-06-01

Full Text Available Abstract Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV or nasogastric (NG. The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR offers benefits over intravenous rehydration (IVR using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV or nasogastric (NG rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640

Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

Science.gov (United States)

Williams, Nefyn H; Jenkins, Alison; Goulden, Nia; Hoare, Zoe; Hughes, Dyfrig A; Wood, Eifiona; Foster, Nadine E; Walsh, David A; Carnes, Dawn; Sparkes, Valerie; Hay, Elaine M; Isaacs, John; Konstantinou, Kika; Morrissey, Dylan; Karppinen, Jaro; Genevay, Stephane; Wilkinson, Clare

2017-10-01

Biological treatments such as adalimumab (Humira ® ; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t -test and 80% retention

Massed Trials versus Trials Embedded into Game Play: Child Outcomes and Preference

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Ledford, Jennifer R.; Chazin, Kate T.; Harbin, Emilee R.; Ward, Sarah E.

2017-01-01

Limited data are available regarding how response prompting procedures should be used in early childhood settings. The purpose of this study was to compare the efficiency of progressive time delay instruction presented via two trial arrangements: massed and embedded. During massed trial sessions, a short instructional session was conducted,…

UK Dermatology Clinical Trials Network's STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial.

Science.gov (United States)

Craig, Fiona F; Thomas, Kim S; Mitchell, Eleanor J; Williams, Hywel C; Norrie, John; Mason, James M; Ormerod, Anthony D

2012-04-28

Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network's STOP GAP Trial has been designed to address this lack of trial evidence. The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and

Transobturator tension-free “inside-to-out” suburethral sling procedure for the treatment of stress urinary incontinence

Directory of Open Access Journals (Sweden)

Laketić Darko

2012-01-01

Full Text Available Introduction. Stress urinary incontinence is an involuntary leakage of urine on a sudden increase of intra-abdominal pressure by physical activity, exercise, coughing, sneezing or laughing. Objective. To assess symptoms, functional and anatomical status of voiding function, complications and short term success of a novel procedure, tension-free vaginal tape obturator technique (TVT-O in the treatment of stress urinary incontinence. Methods. A prospective study was performed on 40 female patients who underwent the TVT-O suburethral sling at the Urology Department of the Health Centre in Prokuplje and Urology Hospital in Niš between May 2009 and February 2010. The mean patients’ age was 58 years (range 34-84 years. Preoperative evaluation included a detailed history and gynaecologic examination including urodynamic testing and voiding studies.UDI-6 and UIQ-7 score testing was performed before, and six months after surgery. All patients who demonstrated stress urinary incontinence with a Q-tip test-angle during maximal straining were included into the study. Postoperatively, outcomes evaluation included voiding function, anatomical parameters, complications, as well as subjective success rates. Results. In 30 patients surgery was performed under spinal and in ten under general anaesthesia. The average intraoperative blood loss during the TVT-O was minimal (<50 ml. There were no vascular, bladder, bowel, and neurological injuries. Thirty-eight patients (95% were discharged voiding satisfactorily. There was a statistically significant difference in symptoms between UDI-6 and UIQ-7 before and after surgery. Conclusion. Initial experience with TVT-O suburethral sling is promising. The TVT-O differs from retropubic procedures by resulting in lower postoperative morbidity, intraoperative and postoperative complications.

A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

Science.gov (United States)

Cherkin, Daniel C.; Sherman, Karen J.; Avins, Andrew L.; Erro, Janet H.; Ichikawa, Laura; Barlow, William E.; Delaney, Kristin; Hawkes, Rene; Hamilton, Luisa; Pressman, Alice; Khalsa, Partap S.; Deyo, Richard A.

2009-01-01

Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. Methods 638 adults with chronic mechanical low back pain were randomized to: individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland Disability score, range: 0 to 23) and symptom bothersomeness (0 to 10 scale). Outcomes were assessed at baseline and after 8, 26 and 52 weeks. Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P0.05). Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture’s purported mechanisms of action. It remains unclear whether acupuncture, or our simulated method of acupuncture, provide physiologically important stimulation or represent placebo or non-specific effects. PMID:19433697

Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials

Science.gov (United States)

Varadhan, Krishna K; Neal, Keith R

2012-01-01

Objective To compare the safety and efficacy of antibiotic treatment versus appendicectomy for the primary treatment of uncomplicated acute appendicitis. Design Meta-analysis of randomised controlled trials. Population Randomised controlled trials of adult patients presenting with uncomplicated acute appendicitis, diagnosed by haematological and radiological investigations. Interventions Antibiotic treatment versus appendicectomy. Outcome measures The primary outcome measure was complications. The secondary outcome measures were efficacy of treatment, length of stay, and incidence of complicated appendicitis and readmissions. Results Four randomised controlled trials with a total of 900 patients (470 antibiotic treatment, 430 appendicectomy) met the inclusion criteria. Antibiotic treatment was associated with a 63% (277/438) success rate at one year. Meta-analysis of complications showed a relative risk reduction of 31% for antibiotic treatment compared with appendicectomy (risk ratio (Mantel-Haenszel, fixed) 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). A secondary analysis, excluding the study with crossover of patients between the two interventions after randomisation, showed a significant relative risk reduction of 39% for antibiotic therapy (risk ratio 0.61 (0.40 to 0.92); I2=0%; P=0.02). Of the 65 (20%) patients who had appendicectomy after readmission, nine had perforated appendicitis and four had gangrenous appendicitis. No significant differences were seen for treatment efficacy, length of stay, or risk of developing complicated appendicitis. Conclusion Antibiotics are both effective and safe as primary treatment for patients with uncomplicated acute appendicitis. Initial antibiotic treatment merits consideration as a primary treatment option for early uncomplicated appendicitis. PMID:22491789

Influences of Thermo-Vacuum Treatment on Colors and Chemical Compositions of Alder Birch Wood

Directory of Open Access Journals (Sweden)

Yan Yang

2015-10-01

Full Text Available With high temperature-heat treatment, the dimensional stability and durability of wood is improved and wood color is darkened as well. In this paper, alder birch wood (Betula alnoides was treated by the Thermo-Vacuum Treatment (TVT. The changes of wood color parameters and the chemical composition were determined by the CIE1976 L*a*b* method and the chemical analysis method, respectively. The results were revealed as follows: (1 A lower value of lightness, L*, and a higher value of total color difference, △E*, were obtained at the higher heat-treatment temperatures and longer treatment time. (2 The higher the heat-treatment temperatures and the longer the heat-treatment times were, the lower the contents of hemicellulose and cellulose were and the higher the content of lignin was. Moreover, Fourier Transform infrared spectroscopy (FTIR analysis demonstrated that the characteristic absorption peaks of cellulose, hemicellulose, and lignin diminished. The acetylation reaction of hemicellulose and the degradation reaction of groups of lignin side chain occurred during TVT. (3 TVT degraded the chemical composition of cell walls, which resulted in further changes of the wood color. A significant correlation existed between the differences of color indices and the differences of the chemical composition after TVT.

Characteristics of children and young adults with Marfan syndrome and aortic root dilation in a randomized trial comparing atenolol and losartan therapy

NARCIS (Netherlands)

Lacro, R.V.; Guey, L.T.; Dietz, H.C.; Pearson, G.D.; Yetman, A.T.; Gelb, B.D.; Loeys, B.L.; Benson, D.W.; Bradley, T.J.; Backer, J. de; Forbus, G.A.; Klein, G.L.; Lai, W.W.; Levine, J.C.; Lewin, M.B.; Markham, L.W.; Paridon, S.M.; Pierpont, M.E.; Radojewski, E.; Selamet Tierney, E.S.; Sharkey, A.M.; Wechsler, S.B.; Mahony, L.; et al.,

2013-01-01

BACKGROUND: The Pediatric Heart Network designed a clinical trial to compare aortic root growth and other short-term cardiovascular outcomes in children and young adults with Marfan syndrome randomized to receive atenolol or losartan. We report here the characteristics of the screened population and

A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856.

Science.gov (United States)

Shubert, Christopher R; Ferrone, Christina R; Fernandez-Del Castillo, Carlos; Kendrick, Michael L; Farnell, Michael B; Smoot, Rory L; Truty, Mark J; Que, Florencia G

2016-11-01

Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either TissueLink or SEAMGUARD. Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula-related morbidity between the two groups. This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical Trials

Medline Plus

Full Text Available ... and compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" means that human choices ...

Very late stent thrombosis with second generation drug eluting stents compared to bare metal stents: Network meta-analysis of randomized primary percutaneous coronary intervention trials.

Science.gov (United States)

Philip, Femi; Stewart, Susan; Southard, Jeffrey A

2016-07-01

The relative safety of drug-eluting stents (DES) and bare-metal stents (BMS) in primary percutaneous coronary intervention (PPCI) in ST elevation myocardial infarction (STEMI) continues to be debated. The long-term clinical outcomes between second generation DES and BMS for primary percutaneous coronary intervention (PCI) using network meta-analysis were compared. Randomized controlled trials comparing stent types (first generation DES, second generation DES, or BMS) were considered for inclusion. A search strategy used Medline, Embase, Cochrane databases, and proceedings of international meetings. Information about study design, inclusion criteria, and sample characteristics were extracted. Network meta-analysis was used to pool direct (comparison of second generation DES to BMS) and indirect evidence (first generation DES with BMS and second generation DES) from the randomized trials. Twelve trials comparing all stents types including 9,673 patients randomly assigned to treatment groups were analyzed. Second generation DES was associated with significantly lower incidence of definite or probable ST (OR 0.59, 95% CI 0.39-0.89), MI (OR 0.59, 95% CI 0.39-0.89), and TVR at 3 years (OR 0.50: 95% CI 0.31-0.81) compared with BMS. In addition, there was a significantly lower incidence of MACE with second generation DES versus BMS (OR 0.54, 95% CI 0.34-0.74) at 3 years. These were driven by a higher rate of TVR, MI and stent thrombosis in the BMS group at 3 years. There was a non-significant reduction in the overall and cardiac mortality [OR 0.83, 95% CI (0.60-1.14), OR 0.88, 95% CI (0.6-1.28)] with the use of second generation DES versus BMS at 3 years. Network meta-analysis of randomized trials of primary PCI demonstrated lower incidence of MACE, MI, TVR, and stent thrombosis with second generation DES compared with BMS. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Iohexol and iopamidol myelography in the dog: a clinical trial comparing adverse effects and myelographic quality

International Nuclear Information System (INIS)

Widmer, W.R.; Blevins, W.E.; Jakovljevic, S.; Teclaw, R.F.; Han, C.M.; Hurd, C.D.

1992-01-01

In a blind clinical trial, adverse effects after iohexol and iopamidol myelography were evaluated in 151 dogs. Eighty-one dogs were given iohexol (240 mgI/ml) and 70 dogs were given iopamidol (200 mgI/ml) by pre-determined assignment. Each dog was evaluated postmyelographically for seizures, hyperthermia, prolonged recovery from anesthesia and intensification of pre-existing neural signs. Myelographic quality was evaluated with a subjective scoring method. In comparing iohexol and iopamidol groups, there was not a statistically significant difference in the incidence of adverse effects or in myelographic quality. Iopamidol and iohexol appeared to be equally efficacious for routine canine myelography

Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial.

Science.gov (United States)

Culligan, Patrick J; Salamon, Charbel; Priestley, Jennifer L; Shariati, Amir

2013-01-01

To compare the surgical outcomes 12 months after laparoscopic sacrocolpopexy performed with porcine dermis and the current gold standard of polypropylene mesh. Patients scheduled for laparoscopic sacrocolpopexy were eligible for this randomized controlled trial. Both our clinical research nurse and the patients were blinded as to which material was used. Our primary end point was objective anatomic cure defined as no pelvic organ prolapse quantification (POP-Q) points Stage 2 or greater at any postoperative interval. Our sample size calculation called for 57 patients in each group to achieve 90% power to detect a 23% difference in objective anatomic cure at 12 months (α=0.05). Our secondary end point was clinical cure. Any patient with a POP-Q point greater than zero, or Point C less than or equal to -5, or any complaints of prolapse symptoms whatsoever on Pelvic Floor Distress Inventory-20 or Pelvic Floor Impact Questionnaire, Short Form 7, or reoperation for prolapse were considered "clinical failures"; the rest were "clinical cures." Statistical comparisons were performed using the χ or independent samples t test as appropriate. As expected, there were no preoperative differences between the porcine (n=57) and mesh (n=58) groups. The 12-month objective anatomic cure rates for the porcine and mesh groups were 80.7% and 86.2%, respectively (P=.24), and the "clinical cure" rates for the porcine and mesh groups were 84.2% and 89.7%, respectively (P=.96). Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire, Short Form 7 score improvements were significant for both groups with no differences found between groups. There were no major operative complications. There were similar outcomes in subjective or objective results 12 months after laparoscopic sacrocolpopexy performed with either porcine dermis or polypropylene mesh. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00564083. I.

Clinical trials of homoeopathy.

Science.gov (United States)

Kleijnen, J; Knipschild, P; ter Riet, G

1991-01-01

OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

A systematic review and meta-analysis of randomized controlled trials comparing hysteroscopic morcellation with resectoscopy for patients with endometrial lesions.

Science.gov (United States)

Li, Chunbo; Dai, Zhiyuan; Gong, Yuping; Xie, Bingying; Wang, Bei

2017-01-01

Results on the efficacy of hysteroscopic morcellation for patients with endometrial lesions remain conflicting. To compare hysteroscopic morcellation with conventional resectoscopy for removal of endometrial lesions. Electronic databases were searched for reports published up to February 1, 2016, using terms such as "morcellator," "morcellators," "morcellate," "morcellation," "morcellated," "hysteroscopy," "hysteroscopy," "uteroscope," and "transcervical." Randomized controlled trials were included if they assessed success rate, procedure speed, complications, tolerability, and/or learning curve. Data were extracted by two independent reviewers and a meta-analysis was performed. Four trials including 392 patients were analyzed. Successful removal of all endometrial lesions was more frequent with hysteroscopic morcellation than conventional resectoscopy (odds ratio 4.49, 95% confidence interval [CI] 1.94-10.41; Physteroscopic morcellation (mean difference -4.94 minutes, 95% CI -7.20 to -2.68; Plearning curve. In one study, hysteroscopic morcellation was acceptable to more patients (P=0.009). Hysteroscopic morcellation is associated with a higher operative success rate and a shorter operative time among patients with endometrial lesions than is resectoscopy. More high-quality trials are required to validate these results. © 2016 International Federation of Gynecology and Obstetrics.

Systematic review and meta-analysis of published trials comparing the effectiveness of transanal endoscopic microsurgery and radical resection in the management of early rectal cancer.

Science.gov (United States)

Sajid, M S; Farag, S; Leung, P; Sains, P; Miles, W F A; Baig, M K

2014-01-01

A systematic analysis was conducted of trials comparing the effectiveness of transanal endoscopic microsurgery (TEMS) with radical resection (RR) for T1 and T2 rectal cancer. An electronic search was carried out of trials reporting the effectiveness of TEMS and RR in the treatment of T1 and T2 rectal cancers. Ten trials including 942 patients were retrieved. There was a trend toward a higher risk of local recurrence (odds ratio 2.78; 95% confidence interval 1.42, 5.44; z = 2.97; P TEMS compared with RR. The risk of distant recurrence, overall survival (odds ratio 0.90; 95% confidence interval 0.49, 1.66; z = 0.33; P = 0.74) and mortality was similar. TEMS was associated with a shorter operation time and hospital stay and a reduced risk of postoperative complications (P TEMS is superior to RR in the management of early rectal cancer. Larger, better designed and executed prospective studies are needed to answer this question. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.

UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

Directory of Open Access Journals (Sweden)

Craig Fiona F

2012-04-01

Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.

Science.gov (United States)

Wang, Chenchen; Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

2018-03-21

To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Prospective, randomized, 52 week, single blind comparative effectiveness trial. Urban tertiary care academic hospital in the United States between March 2012 and September 2016. 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group

Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial.

Directory of Open Access Journals (Sweden)

Astrid V Fahlenkamp

Full Text Available Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV. We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis.220 subjects with elevated PONV risk (Apfel score ≥2 undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up.Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02-5.19, p = 0.044. Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138. After xenon, nausea occurred significantly earlier (p = 0.014, was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups.In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea.EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663.

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

LENUS (Irish Health Repository)

Ederle, Jörg

2010-03-20

Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.

The OA Trial Bank

DEFF Research Database (Denmark)

van Middelkoop, Marienke; Arden, N K; Atchia, I.

2016-01-01

Objective: To evaluate the efficacy of intra-articular (IA) glucocorticoids for knee or hip osteoarthritis (OA) in specific subgroups of patients with severe pain and inflammatory signs using individual patient data (IPD) from existing trials. Design: Randomized trials evaluating one or more IA...... glucocorticoid preparation in patients with knee or hip OA, published from 1995 up to June 2012 were selected from the literature. IPD obtained from original trials included patient and disease characteristics and outcomes measured. The primary outcome was pain severity at short-term follow-up (up to 4 weeks...... Interval 1.50-26.31) when receiving IA glucocorticoid injection compared to placebo. No statistical significant interaction effects were found between inflammatory signs and IA glucocorticoid injections compared to placebo and to tidal irrigation at all follow-up points. Conclusions: This IPD meta...

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

Directory of Open Access Journals (Sweden)

Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

Sequential Multiple Assignment Randomized Trials: An Opportunity for Improved Design of Stroke Reperfusion Trials.

Science.gov (United States)

Meurer, William J; Seewald, Nicholas J; Kidwell, Kelley

2017-04-01

Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice. To characterize a SMART design in comparison to traditional approaches for stroke reperfusion trials. We conducted a numerical simulation study that evaluated the performance of contrasting acute stroke clinical trial designs of both initial reperfusion and rescue therapy. We compare a SMART design where the same patients are followed through initial reperfusion and rescue therapy within 1 trial to a standard phase III design comparing 2 reperfusion treatments and a separate phase II futility design of rescue therapy in terms of sample size, power, and ability to address particular research questions. Traditional trial designs can be well powered and have optimal design characteristics for independent treatment effects. When treatments, such as the reperfusion and rescue therapies, may interact, commonly used designs fail to detect this. A SMART design, with similar sample size to standard designs, can detect treatment interactions. The use of SMART designs to investigate effective and realistic dynamic treatment regimens is a promising way to accelerate the discovery of new, effective treatments for stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A prospective randomised trial comparing mesh types and fixation in totally extraperitoneal inguinal hernia repairs.

Science.gov (United States)

Cristaudo, Adam; Nayak, Arun; Martin, Sarah; Adib, Reza; Martin, Ian

2015-05-01

The totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias has emerged as a popular technique. We conducted a prospective randomised trial to compare patient comfort scores using different mesh types and fixation using this technique. Over a 14 month period, 146 patients underwent 232 TEP inguinal hernia repairs. We compared the comfort scores of patients who underwent these procedures using different types of mesh and fixation. A non-absorbable 15 × 10 cm anatomical mesh fixed with absorbable tacks (Control group) was compared with either a non-absorbable 15 × 10 cm folding slit mesh with absorbable tacks (Group 2), a partially-absorbable 15 × 10 cm mesh with absorbable tacks (Group 3) or a non-absorbable 15 × 10 cm anatomical mesh fixed with 2 ml fibrin sealant (Group 4). Outcomes were compared at 1, 2, 4 and 12 weeks using the Carolina Comfort Scale (CCS) scores. At 1, 2, 4 and 12 weeks, the median global CCS scores were low for all treatment groups. Statistically significant differences were seen only for median CCS scores and subscores with the use of partially-absorbable mesh with absorbable tacks (Group 3) at weeks 2 and 4. However, these were no longer significant at week 12. In this study, the TEP inguinal hernia repair with minimal fixation results in low CCS scores. There were no statistical differences in CCS scores when comparing types of mesh, configuration of the mesh or fixation methods. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only

Science.gov (United States)

Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

2015-01-01

Background Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Methods Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score <9 (original definition), or GCS<13 and an Abbreviated Injury Scale score for the head region ≥3 (modified definition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. Results 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), p<0.01, Number needed to treat =6. 338 patients met the modified definition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. Conclusions This trial suggests a potential mortality reduction in patients with blunt trauma with GCS<9 receiving additional physician care (original definition only). Confirmatory studies which also address non-compliance issues are needed. Trial registration number NCT00112398. PMID:25795741

Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials

Science.gov (United States)

2011-01-01

Background All sectors of the economy, including the health research sector, must reduce their carbon emissions. The UK National Institute for Health Research has recently prepared guidelines on how to minimize the carbon footprint of research. We compare the carbon emissions from two international clinical trials in order to identify where emissions reductions can be made. Methods We conducted a carbon audit of two clinical trials (the CRASH-1 and CRASH-2 trials), quantifying the carbon dioxide emissions produced over a one-year audit period. Carbon emissions arising from the coordination centre, freight delivery, trial-related travel and commuting were calculated and compared. Results The total emissions in carbon dioxide equivalents during the one-year audit period were 181.3 tonnes for CRASH-1 and 108.2 tonnes for CRASH-2. In total, CRASH-1 emitted 924.6 tonnes of carbon dioxide equivalents compared with 508.5 tonnes for CRASH-2. The CRASH-1 trial recruited 10,008 patients over 5.1 years, corresponding to 92 kg of carbon dioxide per randomized patient. The CRASH-2 trial recruited 20,211 patients over 4.7 years, corresponding to 25 kg of carbon dioxide per randomized patient. The largest contributor to emissions in CRASH-1 was freight delivery of trial materials (86.0 tonnes, 48% of total emissions), whereas the largest contributor in CRASH-2 was energy use by the trial coordination centre (54.6 tonnes, 30% of total emissions). Conclusions Faster patient recruitment in the CRASH-2 trial largely accounted for its greatly increased carbon efficiency in terms of emissions per randomized patient. Lighter trial materials and web-based data entry also contributed to the overall lower carbon emissions in CRASH-2 as compared to CRASH-1. Trial Registration Numbers CRASH-1: ISRCTN74459797 CRASH-2: ISRCTN86750102 PMID:21291517

Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials

Directory of Open Access Journals (Sweden)

Roberts Ian

2011-02-01

Full Text Available Abstract Background All sectors of the economy, including the health research sector, must reduce their carbon emissions. The UK National Institute for Health Research has recently prepared guidelines on how to minimize the carbon footprint of research. We compare the carbon emissions from two international clinical trials in order to identify where emissions reductions can be made. Methods We conducted a carbon audit of two clinical trials (the CRASH-1 and CRASH-2 trials, quantifying the carbon dioxide emissions produced over a one-year audit period. Carbon emissions arising from the coordination centre, freight delivery, trial-related travel and commuting were calculated and compared. Results The total emissions in carbon dioxide equivalents during the one-year audit period were 181.3 tonnes for CRASH-1 and 108.2 tonnes for CRASH-2. In total, CRASH-1 emitted 924.6 tonnes of carbon dioxide equivalents compared with 508.5 tonnes for CRASH-2. The CRASH-1 trial recruited 10,008 patients over 5.1 years, corresponding to 92 kg of carbon dioxide per randomized patient. The CRASH-2 trial recruited 20,211 patients over 4.7 years, corresponding to 25 kg of carbon dioxide per randomized patient. The largest contributor to emissions in CRASH-1 was freight delivery of trial materials (86.0 tonnes, 48% of total emissions, whereas the largest contributor in CRASH-2 was energy use by the trial coordination centre (54.6 tonnes, 30% of total emissions. Conclusions Faster patient recruitment in the CRASH-2 trial largely accounted for its greatly increased carbon efficiency in terms of emissions per randomized patient. Lighter trial materials and web-based data entry also contributed to the overall lower carbon emissions in CRASH-2 as compared to CRASH-1. Trial Registration Numbers CRASH-1: ISRCTN74459797 CRASH-2: ISRCTN86750102

Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

Directory of Open Access Journals (Sweden)

Zielinski Stephanie M

2012-01-01

Full Text Available Abstract Background Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures. Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Methods Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Results Median trial start-up ranged from 41 days (P25-P75 10-139 in the Netherlands to 232 days (P25-P75 98-423 in Canada (p = 0.027. The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21 per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28, representing 3.9% of eligible patients (p Conclusions In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. Trial Registration ClinicalTrials.gov: NCT00761813

The TOPSHOCK study: Effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial

Directory of Open Access Journals (Sweden)

Diercks Ron L

2011-10-01

Full Text Available Abstract Background Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. Methods/design The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. Discussion

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

Science.gov (United States)

Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

2015-01-01

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

Directory of Open Access Journals (Sweden)

Marleine Azar

Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

A randomized trial comparing surgeon-administered intraoperative transversus abdominis plane block with anesthesiologist-administered transcutaneous block.

Science.gov (United States)

Narasimhulu, D M; Scharfman, L; Minkoff, H; George, B; Homel, P; Tyagaraj, K

2018-04-27

Injection of local anesthetic into the transversus abdominis plane (TAP block) decreases systemic morphine requirements after abdominal surgery. We compared intraoperative surgeon-administered TAP block (surgical TAP) to anesthesiologist-administered transcutaneous ultrasound-guided TAP block (conventional TAP) for post-cesarean analgesia. We hypothesized that surgical TAP blocks would take less time to perform than conventional TAP blocks. We performed a randomized trial, recruiting 41 women undergoing cesarean delivery under neuraxial anesthesia, assigning them to either surgical TAP block (n=20) or conventional TAP block (n=21). Time taken to perform the block was the primary outcome, while postoperative pain scores and 24-hour opioid requirements were secondary outcomes. Student's t-test was used to compare block time and Kruskal-Wallis test opioid consumption and pain-scores. Time taken to perform the block (2.4 vs 12.1 min, P consumption (P=0.17) and postoperative pain scores at 4, 8, 24 and 48 h were not significantly different between the groups. Surgical TAP blocks are feasible and less time consuming than conventional TAP blocks, while providing comparable analgesia after cesarean delivery. Copyright © 2018 Elsevier Ltd. All rights reserved.

Interactions between rivaroxaban and antiphospholipid antibodies in thrombotic antiphospholipid syndrome.

Science.gov (United States)

Arachchillage, D R J; Mackie, I J; Efthymiou, M; Isenberg, D A; Machin, S J; Cohen, H

2015-07-01

Rivaroxaban can affect lupus anticoagulant (LA) testing and antiphospholipid antibodies (aPL) may interfere with the anticoagulant action of rivaroxaban. To establish the influence of rivaroxaban on LA detection and of aPL on the anticoagulant action of rivaroxaban. Rivaroxaban and 52 IgG preparations (20 LA+ve, 12 LA-ve thrombotic antiphospholipid syndrome [APS] patients, and 20 normal controls [NC]) were spiked into pooled normal plasma (PNP) for relevant studies. LA detection was also studied in APS patients receiving rivaroxaban 20 mg once daily. In vitro spiking of samples with rivaroxaban showed no false positive LA with Textarin time, Taipan venom time/Ecarin clotting time (TVT/ECT), dilute prothrombin time (dPT) and in-house dilute Russell's viper venom time (DRVVT), but false positives in the majority of NC and LA negative IgG with two commercial DRVVT reagents at 250 ng/mL but not 50 ng/mL rivaroxaban. Ex vivo studies: six LA+ve patients on rivaroxaban remained LA positive with TVT/ECT and DRVVT at peak (162-278 ng/mL) and trough (30-85 ng/mL) rivaroxaban levels. Six LA-ve patients became (apparently) LA+ve with two DRVVT reagents (test/confirm ratio median [confidence interval], 1.6 [1.3-1.8], 1.6 [1.4-1.9]) but not with TVT/ECT at peak rivaroxaban levels, and remained LA-ve with both DRVVT reagents and TVT/ECT at trough levels. aPL positive IgG spiking of PNP had no effect on rivaroxaban's anticoagulant action on thrombin generation or rivaroxaban anti-Xa levels. The TVT/ECT ratio and Textarin time were not affected even at peak rivaroxaban levels, enabling detection of LA ex vivo. aPL had no effects on rivaroxaban's anticoagulant action in vitro. © 2015 International Society on Thrombosis and Haemostasis.

To compare the efficacy of two kinds of Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome:a randomized group sequential comparative trial

Science.gov (United States)

2011-01-01

Background In Traditional Chinese Medicine (TCM) theory, functional dyspepsia (FD) can be divided into different syndromes according to different clinical symptoms and signs, and the most common one is spleen-deficiency and qi-stagnation syndrome that can be treated by Chinese traditional patent medicine ---- two kinds of Zhizhu pills, between which the primary difference in ingredients is that one contains immature orange fruit of Citrus aurantium L.(IFCA) and the other contains that of Citrus sinensis Osbeck (IFCS). The trial's objective was to compare the efficacy of two kinds of Zhizhu pills on symptom changes in patients with FD of spleen-deficiency and qi-stagnation syndrome. Methods A randomized, group sequential, double-blinded, multicenter trial was conducted in patients with FD of spleen-deficiency and qi-stagnation syndrome at 3 hospitals in Beijing between June 2003 and May 2005. Participants were randomly allocated into two groups (IFCA group and IFCS group) in a 1:1 ratio, and respectively took one of the two kinds of Zhizhu pills orally, 6 g each time, 3 times a day, for 4 weeks. Statistical analysis was performed with use of a group sequential method, the triangular test (TT). Results A total of 163 patients were randomized, and 3 patients were excluded from analysis because of early dropouts, leaving 160 patients (IFCA group: n = 82; IFCS group: n = 78) for statistical analysis. Three interim analyses were done after 62, 116, and 160 patients had completed their 4-week treatment, respectively. At the third interim analysis, the sample path crossed the upper boundary and the trial was stopped, the cure-markedly effective rates were 45% for IFCS group and 67% for IFCA group, respectively, the one-sided p-value was 0.0036, the median unbiased estimate of the odds ratio (OR) for the benefit of IFCA relative to IFCS was 2.91 with 95%CI: 1.40 to 6.06. No adverse events were observed in the two groups. Conclusions Zhizhu pills containing IFCA was superior

A randomized trial comparing structured and lifestyle goals in an internet-mediated walking program for people with type 2 diabetes

OpenAIRE

Richardson, Caroline R; Mehari, Kathleen S; McIntyre, Laura G; Janney, Adrienne W; Fortlage, Laurie A; Sen, Ananda; Strecher, Victor J; Piette, John D

2007-01-01

Abstract Background The majority of individuals with type 2 diabetes do not exercise regularly. Pedometer-based walking interventions can help; however, pedometer-based interventions targeting only total daily accumulated steps might not yield the same health benefits as physical activity programs specifying a minimum duration and intensity of physical activity bouts. Methods This pilot randomized trial compared two goal-setting strategies: 1) lifestyle goals targeting total daily accumulated...

Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial

DEFF Research Database (Denmark)

Metzger Filho, Otto; Giobbie-Hurder, Anita; Mallon, Elizabeth

2015-01-01

assigned onto the Breast International Group (BIG) 1-98 trial and who had centrally reviewed pathology data were included (N = 2,923). HER2-negative IDC and ILC were additionally classified as hormone receptor-positive with high (luminal B [LB] -like) or low (luminal A [LA] -like) proliferative activity......PURPOSE: To evaluate the relative effectiveness of letrozole compared with tamoxifen for patients with invasive ductal or lobular carcinoma. PATIENTS AND METHODS: Patients diagnosed with early-stage invasive ductal carcinoma (IDC) or classic invasive lobular carcinoma (ILC) who were randomly...

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

NARCIS (Netherlands)

Ederle, J.; Dobson, J.; Featherstone, R.L.; Bonati, L.H.; Worp, H.B. van der; Borst, G.J. de; Lo, T.H.; Gaines, P.; Dorman, P.J.; Macdonald, S.; Lyrer, P.A.; Hendriks, J.M.; McCollum, C.; Nederkoorn, P.J.; Brown, M.M.; Blankensteijn, J.D.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

2010-01-01

BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

NARCIS (Netherlands)

Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Chu, P.; Clark, D.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Saunder, A.; Than, P. G.; Gett, S.; Leggett, D.; McGahan, T.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Stanley, B.; Allard, B.; Atkinson, N.; Cambell, W.; Davies, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; d'Archambeau, O.; Hendriks, J. M. H.; van Schil, P.; St Blasius, A. Z.; Bosiers, M.; Deloose, K.; van Buggenhout, E.; de Letter, J.; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verbist, J.; Blair, J.-F.; Caron, J. L.; Daneault, N.; Giroux, M.-F.; Guilbert, F.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Weill, A.; Hill, M.; Hu, W.; Hudion, M.; Morrish, W.; Sutherland, G.; Wong, J.; Albäck, A.; Harno, H.; Ijäs, P.; Kaste, M.; Lepäntalo, M.; Mustanoja, S.; Paananen, T.; Porras, M.; Putaala, J.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Skalej, M.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van der Lugt, A.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van Urk, H.; Verhagen, H. J. M.; Bruijninckx, C. M. A.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; de Beer, F. C.; van den Berg, J. S. P.; van Hasselt, B. A. A. M.; Zeilstra, D. J.; Boiten, J.; van Otterloo, J. C. A. de Mol; de Vries, A. C.; Lycklama a Nijeholt, G. J.; van der Kallen, B. F. W.; Blankensteijn, J. D.; de Leeuw, F. E.; Kool, L. J. Schultze; van der Vliet, J. A.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; van der Worp, H. B.; Verhagen, H.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Stewart, J.; Bakke, S. J.; Krohg-Sørensen, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Jedrzejewska, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; Obach, V.; Riambau, V.; San Roman, L.; Branera, J.; Canovas, D.; Estela, Jordi; Gaibar, A. Gimenez; Perendreu, J.; Björses, K.; Gottsater, A.; Ivancev, K.; Maetzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Gillgren, P.; Kall, T.-B.; Konrad, P.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Engelter, S. T.; Fluri, F.; Guerke, L.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.; Wasner, M.; Wetzel, S.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Murith, M.; Ruefenacht, D.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; D'Souza, S.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; Nasser, H.-C.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Symth, J. V.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Jackson, R.; Jayakrishnan, V.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Rose, J.; Stansby, G.; Wyatt, M.; Baker, T.; Baldwin, N.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Lonsdale, R.; Nair, R.; Nassef, A.; Nawaz, S.; Venables, G.; Belli, A.; Cloud, G.; Halliday, A.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Thompson, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Malik, I.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Brookes, J.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.

2010-01-01

BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults

DEFF Research Database (Denmark)

Skou, Soren Thorgaard; Lind, Martin; Holmich, Per

2017-01-01

INTRODUCTION: Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger...... adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears. METHODS AND ANALYSIS......: This is a protocol for a multicentre, parallel-group RCT conducted at six hospitals across all five healthcare regions in Denmark. 140 patients aged 18-40 years with a clinical history and symptoms consistent with a meniscal tear, verified on MRI, found eligible for meniscal surgery by an orthopaedic surgeon...

Heterogeneity of Clinical Trials for Antihypertensive Drugs in Japan: Exploratory Analysis of Confirmatory Phase III Trials Used for Marketing Approval.

Science.gov (United States)

Kaneko, Reina; Sano, Kota; Ono, Shunsuke

2018-07-01

The results of pivotal trials, which provide a rationale for marketing approval decisions for new drugs, are considered for various comparative purposes in postmarketing analyses. Using meta-regression analysis of 91 randomized controlled trials of 61 approved antihypertensive drugs in Japan, we show that mean baseline blood pressure (BP) of each arm was associated with predetermined entry criteria (EC), age, and trial start year (TSY). BP changes following treatment were associated with EC, subject characteristics (e.g., age, complications, baseline BP), study design (e.g., concomitant drug use), and TSY. Effect sizes were generally larger in trials for the first and second drugs in the same class than in trials for follow-on drugs. Results of pivotal trials may vary depending on many factors, suggesting possible challenges associated with the comparison of these results indirectly. Due to the heterogeneity in pivotal trials, caution should be exercised when comparing approved drugs and conducting meta-analyses retrospectively. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

Clinical Trials

Medline Plus

Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...

Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

International Nuclear Information System (INIS)

Zakeri, Kaveh; Rose, Brent S.; D’Amico, Anthony V.; Jeong, Jong-Hyeon; Mell, Loren K.

2015-01-01

Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study) : an interim analysis of a randomised controlled trial

NARCIS (Netherlands)

Ederle, Joerg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Bradbury, A.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molynewc, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Hendriks, J. M. H.; Hendriks, J. M.

2010-01-01

Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid

[Meta-analysis of randomized controlled trials comparing procedure for prolapse and hemorrhoids with Milligan-Morgan hemorrhoidectomy in the treatment of prolapsed hemorrhoids].

Science.gov (United States)

He, Ping; Chen, Hongliang

2015-12-01

To compare the safety and efficacy of procedure for prolapse and hemorrhoids (PPH) with Milligan-Morgan hemorrhoidectomy (MMH) in the treatment of prolapsed hemorrhoids. All the randomized controlled trials (RCT) comparing PPH with MMH in the treatment of prolapsed hemorrhoids published between January 1998 and January 2015 were retrieved from PubMed, Embase, Cochrane Library, CBM, CNKI, Wangfang, VIP databases. Hand search was applied in Chinese Journal of Gastrointestinal Surgery, Chinese Journal of Coloproctology and Journal of Colorectal and Anal Surgery from the library of Chengdu University of Traditional Chinese Medicine. Associated reference documents in enrolled trials were reviewed. The methodological quality of enrolled trials was evaluated according to the Cochrane handbook for systematic reviews of interventions. Meta-analysis was performed using RevMan 5.3 software. Sixteen RCTs recruiting 1411 patients were identified. Among them, 702 patients underwent PPH, and other 709 patients MMH. Meta-analysis showed that as compared to MMH, PPH had shorter operating time(WMD=-12.34, 95% CI:-17.87 to -6.80, P=0.000], shorter hospital stay (WMD=-1.48, 95% CI: -1.81 to -1.14, P=0.000) and shorter time to recover normal activity (WMD=-14.11, 95% CI: -24.51 to -3.70, P=0.008). Patients in PPH group experienced less pain at postoperative 24 h, postoperative 1 week and the first postoperative bowel movement (all P0.05). Satisfaction degree of patients in PPH group was better than that in MMH group (OR=2.36, 95% CI:1.36 to 4.07, P=0.002). Procedure for prolapse and hemorrhoids offers some short-term benefits over Milligan-Morgan hemorrhoidectomy, but is associated with a higher rate of recurrent disease.

School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

Directory of Open Access Journals (Sweden)

Andrew W Howard

2009-12-01

Full Text Available The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing.The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar, and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed

Clinical Trials

Medline Plus

Full Text Available ... sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; ... age and frequency for doing screening tests, such as mammography; and compare two or more screening tests ...

The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial

Science.gov (United States)

Thow, Megan; Ferguson, Stuart G

2016-01-01

Background Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. Objectives (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Methods Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Results Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was

Non-inferiority trials: methodological and regulatory challenges

NARCIS (Netherlands)

Wangge, G.

2012-01-01

A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In such trials a drug can be compared with a placebo or with another active compound for the same indication. RCTs can be used to demonstrate that a drug is superior to placebo or an active comparator

The effects of nocturnal compared with conventional hemodialysis on mineral metabolism: A randomized-controlled trial.

Science.gov (United States)

Walsh, Michael; Manns, Braden J; Klarenbach, Scott; Tonelli, Marcello; Hemmelgarn, Brenda; Culleton, Bruce

2010-04-01

Hyperphosphatemia is common among patients receiving dialysis and is associated with increased mortality. Nocturnal hemodialysis (NHD) is a long, slow dialytic modality that may improve hyperphosphatemia and disorders of mineral metabolism. We performed a randomized-controlled trial of NHD compared with conventional hemodialysis (CvHD); in this paper, we report detailed results of mineral metabolism outcomes. Prevalent patients were randomized to receive NHD 5 to 6 nights per week for 6to 10 hours per night or to continue CvHD thrice weekly for 6 months. Oral phosphate binders and vitamin D analogs were adjusted to maintain phosphate, calcium and parathyroid hormone (PTH) levels within recommended targets. Compared with CvHD patients, patients in the NHD group had a significant decrease in serum phosphate over the course of the study (0.49 mmol/L, 95% confidence interval 0.24-0.74; P=0.002) despite a significant reduction in the use of phosphate binders. Sixty-one percent of patients in the NHD group compared with 20% in the CvHD group had a decline in intact PTH (P=0.003). Nocturnal hemodialysis lowers serum phosphate, calcium-phosphate product and requirement for phosphate binders. The effects of NHD on PTH are variable. The impact of these changes on long-term cardiovascular and bone-related outcomes requires further investigation.

Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial

OpenAIRE

Smail-Faugeron , Violaine; Muller-Bolla , Michèle; Sixou , Jean-Louis; Courson , Frédéric

2015-01-01

Introduction Local anaesthesia is commonly used in paediatric oral healthcare. Infiltration anaesthesia is the most frequently used, but recent developments in anaesthesia techniques have introduced an alternative: intraosseous anaesthesia. We propose to perform a split-mouth and parallel-arm multicentre randomised controlled trial (RCT) comparing the pain caused by the insertion of the needle for the injection of conventional infiltration anaesthesia, and intraosseous anaesthesia by the comp...

War on Film: Military History Education. Video tapes, Motion Pictures, and Related Audiovisual Aids

Science.gov (United States)

1987-01-01

results in a film of such impact and realism that it has been kept off television. D-2. War Without Winners II. (Color/TVT/29 min./1982) Brought to...pageantry of this film and the remarkable discipline of its participants is revealed, as vividly as in any cinematic record in existence, the skill of the...Olympia. (B&W/TVT/203 niin./1938) Olympia is one of the famous films of all time-Germany’s cinematic pageant of the 1936 Berlin Olympics. Controversial

Arterial Injury Associated with Tension-Free Vaginal Tapes-SECUR Procedure Successfully Treated by Radiological Embolization

Directory of Open Access Journals (Sweden)

Yun Seok Jung

2010-12-01

Full Text Available Various postoperative complications have been reported after the use of tension-free vaginal tapes (TVT. The transobturator approach was introduced to minimize the potential complications. The next generation of recently introduced TVT-SECUR is intended to minimize the incidence of complications. Herein we report a case of internal pudendal artery injury sustained during this procedure that was successfully treated by radiological embolization. Angiography with vessel embolization, when available, should be considered when the arterial injury is suspected.

A Randomized Controlled Trial for Children with Childhood Apraxia of Speech Comparing Rapid Syllable Transition Treatment and the Nuffield Dyspraxia Programme-Third Edition

Science.gov (United States)

Murray, Elizabeth; McCabe, Patricia; Ballard, Kirrie J.

2015-01-01

Purpose: This randomized controlled trial compared the experimental Rapid Syllable Transition (ReST) treatment to the Nuffield Dyspraxia Programme-Third Edition (NDP3; Williams & Stephens, 2004), used widely in clinical practice in Australia and the United Kingdom. Both programs aim to improve speech motor planning/programming for children…

A combination of subcuticular suture and sterile Micropore tape compared with conventional interrupted sutures for skin closure. A controlled trial.

Science.gov (United States)

Taube, M.; Porter, R. J.; Lord, P. H.

1983-01-01

We have conducted a controlled trial to compare skin closure using conventional interrupted sutures with a combination of subcuticular suture and sterile Micropore tape in 169 patients undergoing appendicectomy, inguinal herniorrhaphy, or saphenofemoral ligation. We have found that the combination technique consistently gives a better cosmetic result and that the tape acts well as a dressing, is convenient, and is well tolerated by patients. Images Fig. 1 Fig. 2 Fig. 3 Fig. 4 PMID:6344732

Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes

DEFF Research Database (Denmark)

Mathiesen, Elisabeth R; Hod, Moshe; Ivanisevic, Marina

2012-01-01

OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized an...

Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)

NARCIS (Netherlands)

Vijgen, S.M.; Ham, D.P. van der; Bijlenga, D.; Beek, J.J. van; Bloemenkamp, K.W.; Kwee, A.; Groenewout, M.; Kars, M.M.; Kuppens, S.; Mantel, G.; Molkenboer, J.F.; Mulder, A.L.; Nijhuis, J.G.; Pernet, P.J.; Porath, M.; Woiski, M.D.; Weinans, M.J.; Wijngaarden, W.J. van; Wildschut, H.I.J.; Akerboom, B.; Sikkema, J.M.; Willekes, C.; Mol, B.W.; Opmeer, B.C.; et al.,

2014-01-01

OBJECTIVE: To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DESIGN: Economic analysis based on a randomized clinical trial. SETTING: Obstetric departments of eight academic and 52 non-academic hospitals in the

Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data.

Science.gov (United States)

Beall, Douglas P; Olan, Wayne J; Kakad, Priyanka; Li, Qianyi; Hornberger, John

2015-01-01

Vertebral compression fractures (VCFs) are the most common osteoporotic fractures and cause persistent pain, kyphotic deformity, weight loss, depression, reduced quality of life, and even death. Current surgical approaches for the treatment of VCF include vertebroplasty (VP) and balloon kyphoplasty (BK). The Kiva® VCF Treatment System (Kiva System) is a next-generation alternative surgical intervention in which a percutaneously introduced nitinol Osteo Coil guidewire is advanced through a deployment cannula and subsequently a PEEK Implant is implanted incrementally and fully coiled in the vertebral body. The Kiva System's effectiveness for the treatment of VCF has been evaluated in a large randomized controlled trial, the Kiva Safety and Effectiveness Trial (KAST). The Kiva System was non-inferior to BK with respect to pain reduction (70.8% vs. 71.8% in Visual Analogue Scale) and physical function restoration (38.1 % vs. 42.2% reduction in Oswestry Disability Index) while using less bone cement. The economic impact of the Kiva system has yet to be analyzed. To analyze hospital resource use and costs of the Kiva System over 2 years for the treatment of VCF compared to BK. A representative US hospital. Economic analysis of the KAST randomized trial, focusing on hospital resource use and costs. The analysis was conducted from a hospital perspective and utilized clinical data from KAST as well as unit-cost data from the published literature. The cost of initial VCF surgery, reoperation cost, device market cost, and other medical costs were compared between the Kiva System and BK. The relative risk reduction rate in adjacent-level fracture with Kiva [31.6% (95% CI: -22.5%, 61.9%)] demonstrated in KAST was used in this analysis. With 304 vertebral augmentation procedures performed in a representative U.S. hospital over 2 years, the Kiva System will produce a direct medical cost savings of $1,118 per patient and $280,876 per hospital. This cost saving with the Kiva

Sample size requirements for separating out the effects of combination treatments: randomised controlled trials of combination therapy vs. standard treatment compared to factorial designs for patients with tuberculous meningitis.

Science.gov (United States)

Wolbers, Marcel; Heemskerk, Dorothee; Chau, Tran Thi Hong; Yen, Nguyen Thi Bich; Caws, Maxine; Farrar, Jeremy; Day, Jeremy

2011-02-02

In certain diseases clinical experts may judge that the intervention with the best prospects is the addition of two treatments to the standard of care. This can either be tested with a simple randomized trial of combination versus standard treatment or with a 2 x 2 factorial design. We compared the two approaches using the design of a new trial in tuberculous meningitis as an example. In that trial the combination of 2 drugs added to standard treatment is assumed to reduce the hazard of death by 30% and the sample size of the combination trial to achieve 80% power is 750 patients. We calculated the power of corresponding factorial designs with one- to sixteen-fold the sample size of the combination trial depending on the contribution of each individual drug to the combination treatment effect and the strength of an interaction between the two. In the absence of an interaction, an eight-fold increase in sample size for the factorial design as compared to the combination trial is required to get 80% power to jointly detect effects of both drugs if the contribution of the less potent treatment to the total effect is at least 35%. An eight-fold sample size increase also provides a power of 76% to detect a qualitative interaction at the one-sided 10% significance level if the individual effects of both drugs are equal. Factorial designs with a lower sample size have a high chance to be underpowered, to show significance of only one drug even if both are equally effective, and to miss important interactions. Pragmatic combination trials of multiple interventions versus standard therapy are valuable in diseases with a limited patient pool if all interventions test the same treatment concept, it is considered likely that either both or none of the individual interventions are effective, and only moderate drug interactions are suspected. An adequately powered 2 x 2 factorial design to detect effects of individual drugs would require at least 8-fold the sample size of the

Fused thiophene-based conjugated polymers and their use in optoelectronic devices

Science.gov (United States)

Facchetti, Antonio; Marks, Tobin J.; Takai, Atsuro; Seger, Mark; Chen; , Zhihua

2017-07-18

The present teachings relate to polymeric compounds and their use as organic semiconductors in organic and hybrid optical, optoelectronic, and/or electronic devices such as photovoltaic cells, light emitting diodes, light emitting transistors, and field effect transistors. The disclosed compounds generally include as repeating units at least one annulated thienyl-vinylene-thienyl (TVT) unit and at least one other pi-conjugated unit. The annulated TVT unit can be represented by the formula: ##STR00001## where Cy.sup.1 and Cy.sup.2 can be a five- or six-membered carbocyclic ring. The annulated TVT unit can be optionally substituted at any available ring atom(s), and can be covalently linked to the other pi-conjugated unit via either the thiophene rings or the carbocyclic rings Cy.sup.1 and Cy.sup.2. The other pi-conjugated unit can be a conjugated linear linker including one or more unsaturated bonds, or a conjugated cyclic linker including one or more carbocyclic and/or heterocyclic rings.

A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

Science.gov (United States)

Girandola, Robert N; Srivastava, Shalini; Loullis, Costas C

2016-04-06

To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. Clinical trials.gov NCT02417506 . 21 January 2015.

Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis

Science.gov (United States)

Fysh, Edward T H; Thomas, Rajesh; Read, Catherine A; Lam, Ben C H; Yap, Elaine; Horwood, Fiona C; Lee, Pyng; Piccolo, Francesco; Shrestha, Ranjan; Garske, Luke A; Lam, David C L; Rosenstengel, Andrew; Bint, Michael; Murray, Kevin; Smith, Nicola A; Lee, Y C Gary

2014-01-01

Introduction Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients’ remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. Methods and analysis The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The

Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

Science.gov (United States)

Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

2016-05-01

). This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.

Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial

Directory of Open Access Journals (Sweden)

Robert B. Saper

2013-01-01

Full Text Available Background. Previous studies have demonstrated that once-weekly yoga classes are effective for chronic low back pain (cLBP in white adults with high socioeconomic status. The comparative effectiveness of twice-weekly classes and generalizability to racially diverse low income populations are unknown. Methods. We conducted a 12-week randomized, parallel-group, dosing trial for 95 adults recruited from an urban safety-net hospital and five community health centers comparing once-weekly (n=49 versus twice-weekly (n=46 standardized yoga classes supplemented by home practice. Primary outcomes were change from baseline to 12 weeks in pain (11-point scale and back-related function (23-point modified Roland-Morris Disability Questionnaire. Results. 82% of participants were nonwhite; 77% had annual household incomes <$40,000. The sample’s baseline mean pain intensity [6.9 (SD 1.6] and function [13.7 (SD 5.0] reflected moderate to severe back pain and impairment. Pain and back-related function improved within both groups (P<0.001. However, there were no differences between once-weekly and twice-weekly groups for pain reduction [-2.1 (95% CI -2.9, -1.3 versus −2.4 (95% CI -3.1, -1.8, P=0.62] or back-related function [-5.1 (95% CI -7.0, -3.2 versus −4.9 (95% CI -6.5, -3.3, P=0.83]. Conclusions. Twelve weeks of once-weekly or twice-weekly yoga classes were similarly effective for predominantly low income minority adults with moderate to severe chronic low back pain. This trial is registered with ClinicalTrials.gov NCT01761617.

A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.

Science.gov (United States)

Hadjigeorgiou, G M; Doxani, C; Miligkos, M; Ziakas, P; Bakalos, G; Papadimitriou, D; Mprotsis, T; Grigoriadis, N; Zintzaras, E

2013-12-01

The relative effectiveness and safety profile of the treatments with marketing authorization for relapsing multiple sclerosis (MS) are not well known because randomized controlled trials with head-to-head comparisons between these treatments do not exist. Thus, a network of multiple-treatments meta-analysis was performed using four clinical outcomes: 'patients free of relapse', 'patients without disease progression', 'patients without MRI progression' and 'patients with adverse events'. Randomized controlled trials (RCTs) on MS were systematically searched in PubMed and Cochrane Central Register of Controlled Trial. The network analysis performed pairwise comparisons between the marketed treatments (Betaferon 250mcg, Avonex 30mcg, Rebif 44mcg, Rebif 22mcg, Aubagio 7 mg, Aubagio 14 mg, Copaxone 20 mg, Tysabri 300 mg, Gilenya 0·5 mg and Novantrone 12 mg/m(2)) using direct and indirect analyses. The analysis included 48 articles, involving 20 455 patients with MS. The direct analysis showed better response for more than one outcome for Gilenya compared with Avonex ('patients free of relapse' and 'patients without MRI progression') and for Betaferon compared with Avonex ('patients without disease progression' and 'patients without MRI progression'). The indirect analysis indicated that Tysabri may have better relative effectiveness compared with the other treatments for two outcomes: 'patients free of relapse' and 'patients without MRI progression'. Regarding 'patients with adverse events', no data were available for all comparisons to make fair inferences. This was an attempt, for the first time, to compare the efficacy and safety profile of existing approved treatments for relapsing MS. Although some treatments have shown better response, the results of the network analysis should be interpreted with caution because of the lack of RCTs with head-to-head comparisons between treatments. © 2013 John Wiley & Sons Ltd.

Internet trials: participant experiences and perspectives.

Science.gov (United States)

Mathieu, Erin; Barratt, Alexandra; Carter, Stacy M; Jamtvedt, Gro

2012-10-23

Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants' attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants' comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience - a perceived benefit - and a lack connectedness and understanding - a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and

Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)

NARCIS (Netherlands)

Vijgen, Sylvia M. C.; Van der Ham, David P.; Bijlenga, Denise; Van Beek, Johannes J.; Bloemenkamp, Kitty W. M.; Kwee, Anneke; Groenewout, Mariet; Kars, Michael M.; Kuppens, Simone; Mantel, Gerald; Molkenboer, Jan F. M.; Mulder, Antonius L. M.; Nijhuis, Jan G.; Pernet, Paula J. M.; Porath, Martina; Woiski, Mallory D.; Weinans, Martin J. N.; Van Wijngaarden, Wim J.; Wildschut, Hajo I. J.; Akerboom, Bertina; Sikkema, J. Marko; Willekes, Christine; Mol, Ben W. J.; Opmeer, Brent C.

ObjectiveTo compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DesignEconomic analysis based on a randomized clinical trial. SettingObstetric departments of eight academic and 52 non-academic hospitals in the Netherlands.

Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)

NARCIS (Netherlands)

Vijgen, Sylvia M. C.; van der Ham, David P.; Bijlenga, Denise; van Beek, Johannes J.; Bloemenkamp, Kitty W. M.; Kwee, Anneke; Groenewout, Mariët; Kars, Michael M.; Kuppens, Simone; Mantel, Gerald; Molkenboer, Jan F. M.; Mulder, Antonius L. M.; Nijhuis, Jan G.; Pernet, Paula J. M.; Porath, Martina; Woiski, Mallory D.; Weinans, Martin J. N.; van Wijngaarden, Wim J.; Wildschut, Hajo I. J.; Akerboom, Bertina; Sikkema, J. Marko; Willekes, Christine; Mol, Ben W. J.; Opmeer, Brent C.

2014-01-01

To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). Economic analysis based on a randomized clinical trial. Obstetric departments of eight academic and 52 non-academic hospitals in the Netherlands. Women with PPROM near

A scientific nutrition strategy improves time trial performance by ≈6% when compared with a self-chosen nutrition strategy in trained cyclists: a randomized cross-over study.

Science.gov (United States)

Hottenrott, Kuno; Hass, Erik; Kraus, Manon; Neumann, Georg; Steiner, Martin; Knechtle, Beat

2012-08-01

We investigated whether an athlete's self-chosen nutrition strategy (A), compared with a scientifically determined one (S), led to an improved endurance performance in a laboratory time trial after an endurance exercise. S consisted of about 1000 mL·h(-1) fluid, in portions of 250 mL every 15 min, 0.5 g sodium·L(-1), 60 g glucose·h(-1), 30 g fructose·h(-1), and 5 mg caffeine·kg body mass(-1). Eighteen endurance-trained cyclists (16 male; 2 female) were tested using a randomized crossover-design at intervals of 2 weeks, following either A or S. After a warm-up, a maximal oxygen uptake test was performed. Following a 30-min break, a 2.5-h endurance exercise on a bicycle ergometer was carried out at 70% maximal oxygen uptake. After 5 min of rest, a time trial of 64.37 km (40 miles) was completed. The ingested nutrition was recorded every 15 min. In S, the athletes completed the time trial faster (128 vs. 136 min; p ≤ 0.001) and with a significantly higher power output (212 vs. 184 W; p ≤ 0.001). The intake of fluid, energy (carbohydrate-, mono-, and disaccharide), and sodium was significantly higher in S compared with A (p ≤ 0.001) during the endurance exercise. In the time trial, only sodium intake was significantly higher in S (p ≤ 0.001). We concluded that a time trial performance after a 2.5-h endurance exercise in a laboratory setting was significantly improved following a scientific nutrition strategy.

Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

Science.gov (United States)

Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

2010-01-01

To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (pattractiveness for biopharmaceutical industry-sponsored clinical trials.

Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Directory of Open Access Journals (Sweden)

Murray Scott A

2009-05-01

Full Text Available Abstract Background Medication errors are an important cause of morbidity and mortality in primary care. The aims of this study are to determine the effectiveness, cost effectiveness and acceptability of a pharmacist-led information-technology-based complex intervention compared with simple feedback in reducing proportions of patients at risk from potentially hazardous prescribing and medicines management in general (family practice. Methods Research subject group: "At-risk" patients registered with computerised general practices in two geographical regions in England. Design: Parallel group pragmatic cluster randomised trial. Interventions: Practices will be randomised to either: (i Computer-generated feedback; or (ii Pharmacist-led intervention comprising of computer-generated feedback, educational outreach and dedicated support. Primary outcome measures: The proportion of patients in each practice at six and 12 months post intervention: - with a computer-recorded history of peptic ulcer being prescribed non-selective non-steroidal anti-inflammatory drugs - with a computer-recorded diagnosis of asthma being prescribed beta-blockers - aged 75 years and older receiving long-term prescriptions for angiotensin converting enzyme inhibitors or loop diuretics without a recorded assessment of renal function and electrolytes in the preceding 15 months. Secondary outcome measures; These relate to a number of other examples of potentially hazardous prescribing and medicines management. Economic analysis: An economic evaluation will be done of the cost per error avoided, from the perspective of the UK National Health Service (NHS, comparing the pharmacist-led intervention with simple feedback. Qualitative analysis: A qualitative study will be conducted to explore the views and experiences of health care professionals and NHS managers concerning the interventions, and investigate possible reasons why the interventions prove effective, or conversely prove

Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

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Grotenhuis J André

2007-11-01

Full Text Available Abstract Background laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. Methods/Design Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. Discussion This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT number ISRCTN72800446

Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care.

Science.gov (United States)

Billot, Laurent; Lindley, Richard I; Harvey, Lisa A; Maulik, Pallab K; Hackett, Maree L; Murthy, Gudlavalleti Vs; Anderson, Craig S; Shamanna, Bindiganavale R; Jan, Stephen; Walker, Marion; Forster, Anne; Langhorne, Peter; Verma, Shweta J; Felix, Cynthia; Alim, Mohammed; Gandhi, Dorcas Bc; Pandian, Jeyaraj Durai

2017-02-01

Background In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke. Objective To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding. Methods Based upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data. Results The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting. Conclusions Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses. Clinical Trial Registrations India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.

Cholgate - a randomized controlled trial comparing the effect of automated and on-demand decision support on the management of cardiovascular disease factors in primary care

NARCIS (Netherlands)

J.T. van Wyk (Jacobus); M.A.M. van Wijk (Marc); P.W. Moorman (Peter); M. Mosseveld (Mees); J. van der Lei (Johan)

2003-01-01

textabstractAutomated and on-demand decision support systems integrated into an electronic medical record have proven to be an effective implementation strategy for guidelines. Cholgate is a randomized controlled trial comparing the effect of automated and on-demand decision

Sample size requirements for separating out the effects of combination treatments: Randomised controlled trials of combination therapy vs. standard treatment compared to factorial designs for patients with tuberculous meningitis

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Farrar Jeremy

2011-02-01

Full Text Available Abstract Background In certain diseases clinical experts may judge that the intervention with the best prospects is the addition of two treatments to the standard of care. This can either be tested with a simple randomized trial of combination versus standard treatment or with a 2 × 2 factorial design. Methods We compared the two approaches using the design of a new trial in tuberculous meningitis as an example. In that trial the combination of 2 drugs added to standard treatment is assumed to reduce the hazard of death by 30% and the sample size of the combination trial to achieve 80% power is 750 patients. We calculated the power of corresponding factorial designs with one- to sixteen-fold the sample size of the combination trial depending on the contribution of each individual drug to the combination treatment effect and the strength of an interaction between the two. Results In the absence of an interaction, an eight-fold increase in sample size for the factorial design as compared to the combination trial is required to get 80% power to jointly detect effects of both drugs if the contribution of the less potent treatment to the total effect is at least 35%. An eight-fold sample size increase also provides a power of 76% to detect a qualitative interaction at the one-sided 10% significance level if the individual effects of both drugs are equal. Factorial designs with a lower sample size have a high chance to be underpowered, to show significance of only one drug even if both are equally effective, and to miss important interactions. Conclusions Pragmatic combination trials of multiple interventions versus standard therapy are valuable in diseases with a limited patient pool if all interventions test the same treatment concept, it is considered likely that either both or none of the individual interventions are effective, and only moderate drug interactions are suspected. An adequately powered 2 × 2 factorial design to detect effects of

Comparing the analgesic effect of heat patch containing iron chip and ibuprofen for primary dysmenorrhea: a randomized controlled trial

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Navvabi Rigi Shahindokht

2012-08-01

Full Text Available Abstract Background Primary dysmenorrhea is a common and sometimes disabling condition. In recent years, some studies aimed to improve the treatment of dysmenorrhea, and therefore, introduced several therapeutic measures. This study was designed to compare the analgesic effect of iron chip containing heat wrap with ibuprofen for the treatment of primary dysmenorrhea. Methods In this randomized (IRCT201107187038N2 controlled trial, 147 students (18–30 years old with the diagnosis of primary dysmenorrhea were enrolled considering the CONSORT guideline. Screening for primary dysmenorrhea was done by a two-question screening tool. The participants were randomly assigned into one of the intervention groups (heat Patch and ibuprofen. Data regarding the severity and emotional impact of the pain were recorded by a shortened version of McGill Pain Questionnaire (SF-MPQ. Student's t test was used for statistical analysis. Results The maximum and minimum pain severities were observed at 2 and 24 hours in both groups. The severity of sensual pain at 8, 12, and 24 hours was non-significantly less in the heat Patch group. There was also no significant difference between the groups regarding the emotional impact of pain at the first 2, 4, 8, 12 and 12 hours of menstruation. Conclusions Heat patch containing Iron chip has comparable analgesic effects to ibuprofen and can possibly be used for primary dysmenorrhea. Trial registration IRCT201107187038N2

Review on midurethral sling procedures for stress urinary incontinence

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Nazura Bt Karim

2015-05-01

Full Text Available Minimally invasive suburethral slings, namely the retropubic suburethral sling or the tension-free vaginal tape (TVT, has become the mainstay for surgical management of moderate to severe stress urinary incontinence (SUI taking over the place of Burch's colposuspension after its introduction in the 1990s. Following the introduction of retropubic sling procedures are the transobturator (TVT-O procedures and the mini-sling procedures. This review attempts to summarize the current trend of midurethral sling (MUS procedures in the management of SUI.

Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania.

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Thallinger, Monica; Ersdal, Hege Langli; Francis, Fortunata; Yeconia, Anita; Mduma, Estomih; Kidanto, Hussein; Linde, Jørgen Erland; Eilevstjønn, Joar; Gunnes, Nina; Størdal, Ketil

2017-07-01

Effective ventilation is crucial to save non-breathing newborns. We compared standard equipment for newborn resuscitation to a new Upright bag, in an area with high neonatal mortality. Newborns requiring resuscitation at Haydom Lutheran Hospital, Tanzania, were ventilated with 230ml standard or 320ml Upright bag-mask by weekly non-blinded block randomisation. A Laerdal Newborn Resuscitation Monitor collected ventilation data through a flow sensor between mask and bag and heart rate with electrocardiography electrodes. Primary outcome was expiratory tidal volume per birth weight. Of 6110 babies born, 136 randomised to standard bag-mask and 192 to Upright, both groups had similar birth weight, gestational age, Apgar scores, gender, and mode of delivery. Compared to standard bag-mask, Upright gave higher median expiratory tidal volume (8.6ml/kg (IQR: 3.5-13.8) vs. 10.0ml/kg (IQR: 4.3-16.8) difference ratio 1.29, 95%CI 1.05, 1.58, p=0.014)), increased mean airway and peak inspiratory pressures, and higher early expired CO 2 (median at 20s 4.2% vs. 3.2%, p=0.0099). Clinical outcome 30min post-delivery was normal in 44% with standard versus 57% with Upright (p=0.016), but similar at 24h. Upright provided higher expired tidal volume, MAP, PIP and early ECO 2 than the standard bag. Clinical outcome differed at 30min, but not at 24h. Larger volume of Upright than standard bag can be an important factor. The results are relevant for low- and high-income settings as ventilatory and heart rate parameters during resuscitation of newborns are rarely reported. Trial registered at www.ClinicalTrials.gov, NCT01869582. Copyright © 2017 Elsevier B.V. All rights reserved.

No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control.

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Donal G MacCoon

Full Text Available Mindfulness Based Stress Reduction (MBSR is a secular form of meditation training. The vast majority of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons. Previous studies have found that meditation training over several months is associated with improvements in cognitive control and attention.We used a visual continuous performance task (CPT to test the effects of eight weeks of mindfulness training on sustained attention by comparing MBSR to the Health Enhancement Program (HEP, a structurally equivalent, active control condition in a randomized, longitudinal design (ClinicalTrials.gov, NCT01301105 focusing on a non-clinical population typical of MBSR participants. Researchers were blind to group assignment. 63 community participants were randomized to either MBSR (n = 31 or HEP (n = 32. CPT analyses were conducted on 29 MBSR participants and 25 HEP participants. We predicted that MBSR would improve visual discrimination ability and sustained attention over time on the CPT compared to HEP, with more home practice associated with greater improvements. Our hypotheses were not confirmed but we did find some evidence for improved visual discrimination similar to effects in partial replication of other research. Our study had sufficient power to demonstrate that intervention groups do not differ in their improvement over time in sustained attention performance. One of our primary predictions concerning the effects of intervention on attentional fatigue was significant but not interpretable.Attentional sensitivity is not affected by mindfulness practice as taught in MBSR, but it is unclear whether mindfulness might positively affect another aspect of attention, vigilance. These results also highlight the relevant procedural modifications required by future research to correctly investigate the role of sustained attention in similar samples.ClinicalTrials.gov, NCT

CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials.

Science.gov (United States)

Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

2011-03-01

Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of knowledge about patients' lifestyle behaviors that may affect cancer's progression and recurrence, and limited ability to compile and interpret the wide range of variables that must be considered in the cancer treatment. This lack of data integration limits the potential for patients and clinicians to engage in fully informed decision-making regarding cancer prevention, treatment, and survivorship care, and the translation of research results into mainstream medical care. Particularly important, as noted in a 2009 report on CER to the President and Congress, the limited focus on health behavior-change interventions was a major hindrance in this research landscape (DHHS 2009). This paper describes an initiative to improve CER for cancer by addressing several of these limitations. The Cyberinfrastructure for Comparative Effectiveness Research (CYCORE) project, informed by the National Science Foundation's 2007 report "Cyberinfrastructure Vision for 21(st) Century Discovery" has, as its central aim, the creation of a prototype for a user-friendly, open-source cyberinfrastructure (CI) that supports acquisition, storage, visualization, analysis, and sharing of data important for cancer-related CER. Although still under development, the process of gathering requirements for CYCORE has revealed new ways in which CI design can significantly improve the collection and analysis of a wide variety of data types, and has resulted in new and important partnerships among cancer researchers engaged in

A comparative trial of psychotherapy and pharmacotherapy for "pure" dysthymic patients.

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Markowitz, John C; Kocsis, James H; Bleiberg, Kathryn L; Christos, Paul J; Sacks, Michael

2005-12-01

Psychotherapy of "pure" dysthymic disorder remains understudied. This article reports outcomes of an acute randomized trial of 94 subjects treated for 16 weeks with either interpersonal psychotherapy (IPT), brief supportive psychotherapy (BSP), sertraline, or sertraline plus IPT. Recruited by clinical referral and advertising, subjects met DSM-IV criteria for early onset dysthymic disorder, with no episode of major depression in the prior six months. They were randomly assigned to one of four 16-week treatments, with options for crossover or continuation treatment. Results were analyzed from the intention-to-treat sample by ANCOVA, controlling for baseline depressive severity. Subjects improved in all conditions over time, with the cells including sertraline pharmacotherapy showing superiority over psychotherapy alone for response and remission. Response rates were 58% for sertraline alone, 57% for combined treatment, 35% for IPT, and 31% for BSP. The study was underpowered and may have employed too "active" a control condition. Follow-up data were unobtainable. In this acute trial for "pure" dysthymic disorder, sertraline with or without IPT showed advantages relative to IPT and BSP. Methodological difficulties may have limited differential outcome findings. This study bolsters a small but growing literature on the treatment of dysthymic disorder, suggesting that pharmacotherapy may acutely benefit patients more than psychotherapy.

Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial.

Science.gov (United States)

van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G

2018-01-01

had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.

End-tidal control vs. manually controlled minimal-flow anesthesia: a prospective comparative trial.

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Wetz, A J; Mueller, M M; Walliser, K; Foest, C; Wand, S; Brandes, I F; Waeschle, R M; Bauer, M

2017-11-01

To ensure safe general anesthesia, manually controlled anesthesia requires constant monitoring and numerous manual adjustments of the gas dosage, especially for low- and minimal-flow anesthesia. Oxygen flow-rate and administration of volatile anesthetics can also be controlled automatically by anesthesia machines using the end-tidal control technique, which ensures constant end-tidal concentrations of oxygen and anesthetic gas via feedback and continuous adjustment mechanisms. We investigated the hypothesis that end-tidal control is superior to manually controlled minimal-flow anesthesia (0.5 l/min). In this prospective trial, we included 64 patients undergoing elective surgery under general anesthesia. We analyzed the precision of maintenance of the sevoflurane concentration (1.2-1.4%) and expiratory oxygen (35-40%) and the number of necessary adjustments. Target-concentrations of sevoflurane and oxygen were maintained at more stable levels with the use of end-tidal control (during the first 15 min 28% vs. 51% and from 15 to 60 min 1% vs. 19% deviation from sevoflurane target, P tidal oxygen (5, IQR 3-6). The target-concentrations were reached earlier with the use of end-tidal compared with manual controlled minimal-flow anesthesia but required slightly greater use of anesthetic agents (6.9 vs. 6.0 ml/h). End-tidal control is a superior technique for setting and maintaining oxygen and anesthetic gas concentrations in a stable and rapid manner compared with manual control. Consequently, end-tidal control can effectively support the anesthetist. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only.

Science.gov (United States)

Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

2015-11-01

Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score definition), or GCSdefinition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), pdefinition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. This trial suggests a potential mortality reduction in patients with blunt trauma with GCSdefinition only). Confirmatory studies which also address non-compliance issues are needed. NCT00112398. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.