Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
NCT ID: NCT00135616
Last Updated: 2007-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2005-03-31
2008-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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surgical placement of a suburethral sling tvt or tvt-o
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of stress urinary incontinence requiring surgical management
* Must be able to read and sign the consent
Exclusion Criteria
* Anti-coagulant treatment
* Isolated overactive bladder syndrome
* Genital prolapse requiring surgical treatment
* Concomitant hysterectomy
18 Years
95 Years
FEMALE
No
Sponsors
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Hopital Antoine Beclere
OTHER
Principal Investigators
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Xavier Deffieux, MD
Role: PRINCIPAL_INVESTIGATOR
Hopital Antoine Beclere, Clamart, France
Locations
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CHU Amiens
Amiens, , France
Centre Hospitalier Universitaire
Angers, , France
CHU Pellegrin
Bordeaux, , France
Hopital Saint Andre
Bordeaux, , France
CH Chambery
Chambéry, , France
Hopital Antoine Beclere
Clamart, , France
Hôtel Dieu
Clermont-Ferrand, , France
CH Dunkerque
Dunkirk, , France
Centre Hospitalier Paul Ardier
Issoire, , France
Chu Nancy
Nancy, , France
CH Caremeau
Nîmes, , France
Hopital Diaconesses Croix Saint Simon
Paris, , France
CH Rennes
Rennes, , France
CH Rouen
Rouen, , France
Countries
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Other Identifiers
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xd01
Identifier Type: -
Identifier Source: org_study_id