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Sponsored by: |
Hopital Antoine Beclere |
Information provided by: | Hopital Antoine Beclere |
ClinicalTrials.gov Identifier: | NCT00135616 |
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.
Condition | Intervention | Phase |
Urinary Incontinence, Stress |
Device: surgical placement of a suburethral sling tvt or tvt-o |
Phase IV |
MedlinePlus related topics: | Pelvic Support Problems Stress Urinary Incontinence |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O. |
Estimated Enrollment: | 180 |
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.
Ages Eligible for Study: | 18 Years to 95 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |||||
Hopital Antoine Beclere | |||||
Clamart, France, 92140 | |||||
CH Dunkerque | |||||
Dunkerque, France, 59000 | |||||
Centre Hospitalier Paul Ardier | |||||
Issoire, France, 63500 | |||||
Hôtel Dieu | |||||
Clermont-Ferrand, France, 63058 | |||||
Centre Hospitalier Universitaire | |||||
Angers, France, 49000 | |||||
Hopital Saint Andre | |||||
Bordeaux, France, 33000 | |||||
CHU Amiens | |||||
Amiens, France, 80000 | |||||
CHU NANCY | |||||
Nancy, France | |||||
CH Caremeau | |||||
Nimes, France, 30000 | |||||
CH Rouen | |||||
Rouen, France, 76000 | |||||
CH Rennes | |||||
Rennes, France, 35000 | |||||
CHU Pellegrin | |||||
Bordeaux, France, 33000 | |||||
Hopital Diaconesses Croix Saint Simon | |||||
Paris, France, 75012 | |||||
CH Chambery | |||||
Chambery, France, 73000 |
Hopital Antoine Beclere |
Principal Investigator: | Xavier Deffieux, MD | Hopital Antoine Beclere, Clamart, France |
Study ID Numbers: | xd01 |
First Received: | August 25, 2005 |
Last Updated: | April 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00135616 |
Health Authority: | France: Ministry of Health; France: Afssaps - French Health Products Safety Agency |
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