A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)
Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.
Stress Urinary Incontinence
Device: Tension-free vaginal tape obturator system
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence|
- Overall incidence of treatment success.
- Assessment of unresolved de novo urgency post-treatment.
- No additional surgery required to correct SUI post-treatment
- Intraoperative and postoperative complications
- Quality-of-life measurements
- Return to usual activity
- Patient satisfaction
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||March 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196521
Show 19 Study Locations
|Study Director:||Martin Weisberg, MD||Ethicon, Inc.|