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

Urinary Incontinence, Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00135616
• Other study ID #: xd01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 25, 2005
• Last updated: April 27, 2007
• Start date: March 2005
• Est. completion date: March 2008

Study information

• Verified date: April 2007
• Source: Hopital Antoine Beclere
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• surgical placement of a suburethral sling tvt or tvt-o

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	Centre Hospitalier Universitaire	Angers
France	CHU Pellegrin	Bordeaux
France	Hopital Saint Andre	Bordeaux
France	CH Chambery	Chambery
France	Hopital Antoine Beclere	Clamart
France	Hôtel Dieu	Clermont-Ferrand
France	CH Dunkerque	Dunkerque
France	Centre Hospitalier Paul Ardier	Issoire
France	Chu Nancy	Nancy
France	CH Caremeau	Nimes
France	Hopital Diaconesses Croix Saint Simon	Paris
France	CH Rennes	Rennes
France	CH Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Antoine Beclere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre operative complication: rate of bladder perforation
Primary	post operative complication: rate of post-operative pain
Secondary	efficacy: disparation of urinary incontinence
Secondary	safety: sexual behaviour