A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up.

Abstract

This study was undertaken to compare tension-free vaginal tape (TVT) with colposuspension as the primary treatment for stress incontinence. The trial was conducted in gynecology or urology departments in 14 centers in the United Kingdom and Ireland. Three hundred forty-four women with urodynamic stress incontinence were randomly assigned to groups: 175 to TVT and 169 to colposuspension. Patients were assessed using the Short Form-36 health status questionnaire, the Bristol Female Lower Urinary Tract Symptoms questionnaire, clinical examination, and a 1-hour perineal pad test. Unpaired and paired data were analyzed with the Wilcoxon rank sum and matched pairs tests, respectively, and proportions were compared with the Fisher exact test. When data were analyzed on an intention-to-treat basis, assuming patients with missing data to be treatment failures, 63% of the TVT group and 51% of the colposuspension group were objectively cured at 2 years (odds ratio 1.67, 95% CI 1.09-2.58). The TVT procedure appears to be as effective as colposuspension for the treatment of urodynamic stress incontinence at 2 years.