NCT00196521

A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)

A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Ethicon, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Tension-free vaginal tape obturator system

Timeline

• Start date: 2005-01-01
• Completion: 2007-03-01
• First posted: 2005-09-20
• Last updated: 2007-12-13

Locations

19 sites across 7 countries: United States, Canada, France, Germany, Singapore, South Korea, United Kingdom