Clinical trial NCT00135616: Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
Official title: Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Incontinence, Stress
Keywords: urinary incontinence
stress incontinence
urethra
gynaecologic surgical procedures
suburethral sling
Lead sponsor: Hopital Antoine Beclere
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: pre operative complication: rate of bladder perforation
measure: post operative complication: rate of post-operative pain
Secondary outcomes:
measure: efficacy: disparation of urinary incontinence
measure: safety: sexual behaviour
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Chambery
country: France
facility: CH Chambery
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Clermont-Ferrand
country: France
facility: Hôtel Dieu
city: Dunkerque
country: France
facility: CH Dunkerque
city: Issoire
country: France
facility: Centre Hospitalier Paul Ardier
city: Nancy
country: France
facility: Chu Nancy
city: Nimes
country: France
facility: CH Caremeau
city: Paris
country: France
facility: Hopital Diaconesses Croix Saint Simon
city: Rennes
country: France
facility: CH Rennes
city: Rouen
country: France
facility: CH Rouen
Study officials:
affiliation: Hopital Antoine Beclere, Clamart, France
name: Xavier Deffieux, MD
role: PRINCIPAL_INVESTIGATOR
References: