Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
Recruitment status was Active, not recruiting
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.
Urinary Incontinence, Stress
Device: surgical placement of a suburethral sling tvt or tvt-o
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.|
- pre operative complication: rate of bladder perforation
- post operative complication: rate of post-operative pain
- efficacy: disparation of urinary incontinence
- safety: sexual behaviour
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||March 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135616
|Amiens, France, 80000|
|Centre Hospitalier Universitaire|
|Angers, France, 49000|
|Bordeaux, France, 33000|
|Hopital Saint Andre|
|Bordeaux, France, 33000|
|Chambery, France, 73000|
|Hopital Antoine Beclere|
|Clamart, France, 92140|
|Clermont-Ferrand, France, 63058|
|Dunkerque, France, 59000|
|Centre Hospitalier Paul Ardier|
|Issoire, France, 63500|
|Nimes, France, 30000|
|Hopital Diaconesses Croix Saint Simon|
|Paris, France, 75012|
|Rennes, France, 35000|
|Rouen, France, 76000|
|Principal Investigator:||Xavier Deffieux, MD||Hopital Antoine Beclere, Clamart, France|