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Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:
A Randomized Trial Comparing the Monarc Subfascial Hammock Procedure With Tension-free Vaginal Tape Procedure for the Surgical Treatment of Stress Urinary Incontinence

Clinical Trial Summary

Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary incontinence.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00475839
Study type Interventional
Source The Cleveland Clinic
Contact
Status Completed
Phase Phase 3
Start date December 2004
Completion date July 2007
View Details
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