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Urinary Stress Incontinence clinical trials

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NCT ID: NCT01754558 Completed - Clinical trials for Urinary Stress Incontinence

One Year Outcome Using the Ajust System for Treatment of Urinary Stress Incontinence

Start date: May 2012
Phase: N/A
Study type: Interventional

During the last decade numerous new procedures have been presented regarding surgical treatment of urinary stress incontinence (1,2). Development of the midurethral tape procedure (TVT) changed the surgical procedure dramatically both regarding the extent of the surgical procedure and also decreased the morbidity remarkably. The success rate of the TVT procedure has been proven to be high (1,2 ). However, the development of the TOT/TVT-O procedures disclosed a new fixation point and further decreased the risk of bladder injury (1,2). Since the introduction of trans-obturator slings several mini-slings have been introduced in order to reduce the need of perforation of the skin and muscles (3,4,5). Although some systems seem promising (5) others have disclosed a long learning curve, pain problems following the procedure and lower success rates, compared to the traditional sling procedures. None of these mini-slings have been adjustable. Recently the Ajust system for treatment of stress urinary incontinence was introduced. The system is a single incision sling procedure and consists of an adjustable Polypropylene mesh sling with self fixation anchors (6). In a feasibility study (6), the 6 months objective cure rate was 82%, but there is a lack of information regarding adverse events and durability of treatment success. Our preliminary experiences suggest, that the procedure has a rapid learning curve, low pain scores postoperatively and a 94% cure rate at 3 months follow-up (personal observation). Recently, several abstracts have indicated that the cure rate obtained by Ajust is comparable to TVT or TVT-O (10-12). The purpose of the present study is (primary outcome): To test the hypothesis that the Ajust and TVT, TVT-O and TOT, respectively are equal regarding subjective cure rate (cure is defined as subjectively not incontinent at all), i.e. the study is designed as a non-inferiority study. The study is performed as a randomised controlled trial without blinding. The study is powered to detect a 9% difference between the two groups. The subjective cure rate is based on ICIQ measurement Secondary outcome: - To test the hypothesis that Ajust is associated with a significantly lower postoperative pain perception. - To test the hypothesis that antibiotic treatment is not necessary

NCT ID: NCT01392651 Completed - Clinical trials for Urinary Stress Incontinence

Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI

Start date: January 2009
Phase: N/A
Study type: Observational

Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.

NCT ID: NCT00984958 Completed - Treatment Clinical Trials

Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure

Start date: October 2009
Phase: N/A
Study type: Interventional

The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD.

NCT ID: NCT00904618 Completed - Clinical trials for Urinary Stress Incontinence

Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The objective was to observe the satisfaction of local anesthesia during the implantation of the TVT-SECUR for the treatment of stress urinary incontinence, with the use of questionnaires completed by the patients, and to evaluate the short-term efficacy and safety of the sling, with a comparison of the two techniques of implantation: the 'U-Method' and the 'Hammock' technique.

NCT ID: NCT00762593 Active, not recruiting - Clinical trials for Urinary Stress Incontinence

Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence

KEAT F1
Start date: January 2006
Phase: Phase 2
Study type: Interventional

To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women

NCT ID: NCT00379314 Active, not recruiting - Clinical trials for Urinary Stress Incontinence

Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence

Start date: April 2004
Phase: Phase 3
Study type: Interventional

The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.

NCT ID: NCT00308009 Completed - Clinical trials for Pelvic Organ Prolapse

Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

Start date: February 2002
Phase: N/A
Study type: Interventional

It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

NCT ID: NCT00190853 Completed - Clinical trials for Urinary Stress Incontinence

Biomechanical and Electrophysiological Effects of Duloxetine in the Treatment of Women With Urinary Stress Incontinence

Start date: January 2005
Phase: Phase 3
Study type: Interventional

Biomechanical and electrophysiological effects of duloxetine in the treatment of women with urinary stress incontinence

NCT ID: NCT00190619 Completed - Clinical trials for Urinary Stress Incontinence

Efficacy and Safety of Duloxetine

Start date: May 2001
Phase: Phase 3
Study type: Interventional

The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.

NCT ID: NCT00190606 Completed - Clinical trials for Urinary Stress Incontinence

Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence

Start date: January 2002
Phase: Phase 2
Study type: Interventional

The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence