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

Hopital Antoine Beclere

Status and phase

Unknown

Phase 4

Conditions

Urinary Incontinence, Stress

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00135616

xd01

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

Female

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria