Prospective randomized trial comparing synthetic vs biological out-in transobturator tape: a mean 3-year follow-up study.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to prospectively and randomly compare the outcome of surgical treatment of female stress urinary incontinence (SUI) using the same outside-inside transobturator technique with biological (PelviLaceTO) or synthetic (UretexTO) material sling, evaluating if the biological material can prevent vaginal erosion retaining the "cure rate" of this surgical technique.
METHODS: Seventy patients with SUI were selected, randomly assigned to either UretexTO (n = 34) or PelviLaceTO (n = 36), and underwent the same surgery.
RESULTS: There is no significant difference between two study arms with regard to objective and subjective cure rates and quality of life. In both groups we had an overlap cure rate (UretexTO group 88.2% vs PelviLaceTO group 88.8%) at mean 3 years follow-up. It found no perioperative complications nor vaginal erosions.
CONCLUSIONS: UretexTO and PelviLaceTO are two similarly safe and efficient slings in the management of SUI, with a good patient satisfaction and without any complications.

RCT Entities:   Population Interventions Outcomes