Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence

Abstract

Introduction and hypothesis: This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur (TVT-S) with the trans vaginal obturator tape (TVT-O) for the treatment of stress urinary incontinence.

Methods: We set out to enroll 136 patients in our study. 106 patients with stress urinary incontinence were randomized to either the TVT-S (n = 56) or TVT-O (n = 50) procedure. Patients were evaluated postoperatively at 2 months and 1 year. Our primary outcome was objective cure measured by the cough test. Secondary outcomes of subjective symptoms, questionnaires, pain scores, complications, and urodynamic studies were also included. Statistical analysis was by Chi-squared, Kruskal-Wallis, Wilcoxon, and Fisher's exact tests as appropriate. P values of <0.05 were considered significant.

Results: Objective cure rates were better for TVT-O compared with TVT-S at 1 year (86 % and 63 % respectively, p = 0.01). Subjective cure rates were 88 % for TVT-O and 63 % for TVT-S. Quality of life scores through questionnaires improved in both groups and were not statistically different. Initial post-operative groin pain was more prevalent in the TVT-O group; however, this resolved quickly with time.

Conclusion: TVT-O was superior to TVT-S in the objective cure of stress urinary incontinence at 1-year follow-up.

Trial registration: ClinicalTrials.gov NCT00527696.