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

Abstract

Objective: This study was undertaken to compare tension-free vaginal tape (TVT) with colposuspension as the primary treatment for stress incontinence.

Study design: 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.

Results: 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).

Conclusion: The TVT procedure appears to be as effective as colposuspension for the treatment of urodynamic stress incontinence at 2 years.