Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Device: surgical placement of a suburethral sling tvt or tvt-o


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: surgical placement of a suburethral sling tvt or tvt-o|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre operative complication: rate of bladder perforation |  |  | 
| post operative complication: rate of post-operative pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy: disparation of urinary incontinence |  |  | 
| safety: sexual behaviour |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, stress incontinence, urethra, gynaecologic surgical procedures, suburethral sling