Overview

This trial is active, not recruiting.

Condition urinary incontinence, stress
Treatment surgical placement of a suburethral sling tvt or tvt-o
Phase phase 4
Sponsor Hopital Antoine Beclere
Start date March 2005
End date March 2008
Trial size 180 participants
Trial identifier NCT00135616, xd01

Summary

The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
pre operative complication: rate of bladder perforation
time frame:
post operative complication: rate of post-operative pain
time frame:

Secondary Outcomes

Measure
efficacy: disparation of urinary incontinence
time frame:
safety: sexual behaviour
time frame:

Eligibility Criteria

Female participants from 18 years up to 95 years old.

Inclusion Criteria: - Woman over 18 years old - Clinical diagnosis of stress urinary incontinence requiring surgical management - Must be able to read and sign the consent Exclusion Criteria: - Pregnancy - Anti-coagulant treatment - Isolated overactive bladder syndrome - Genital prolapse requiring surgical treatment - Concomitant hysterectomy

Additional Information

Official title Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.
Principal investigator Xavier Deffieux, MD
Description Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available. At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications. Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain. Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hopital Antoine Beclere.