Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
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|ClinicalTrials.gov Identifier: NCT00135616|
Recruitment Status : Unknown
Verified April 2007 by Hopital Antoine Beclere.
Recruitment status was: Active, not recruiting
First Posted : August 26, 2005
Last Update Posted : April 30, 2007
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Stress||Device: surgical placement of a suburethral sling tvt or tvt-o||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.|
|Study Start Date :||March 2005|
|Estimated Study Completion Date :||March 2008|
- pre operative complication: rate of bladder perforation
- post operative complication: rate of post-operative pain
- efficacy: disparation of urinary incontinence
- safety: sexual behaviour
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|