A prospective randomized trial comparing tension-free vaginal tape and transobturator suburethral tape for surgical treatment of stress urinary incontinence.

ABSTRACT

OBJECTIVE: The purpose of this study was to prospectively and randomly compare tension-free vaginal tape (TVT) with transobturator suburethral tape (T.O.T.) for the surgical treatment of stress urinary incontinence (SUI) in women. STUDY DESIGN: Sixty-one women with SUI were randomly assigned to either TVT (n=31) or T.O.T. (n=30). The preoperative evaluation included a quality-of-life questionnaire and a comprehensive urodynamic examination. The 1-year outcome included a detrusor pressure-uroflow study to compare bladder outlet obstruction. RESULTS: Patient characteristics, preoperative quality of life, and urodynamic evaluation were similar in the 2 groups. Mean operative time was significantly shorter in the T.O.T. group (15 min+/-4 vs 27 min+/-8, P<.001). No bladder injury occurred in the T.O.T. group versus 9.7% (n=3) in the TVT group (P>.05). The rate of postoperative urinary retention was 25.8% (n=8) in the TVT group versus 13.3% (n=4) in the T.O.T. group (P>.05). The rates of cure (83.9% vs 90%), improvement (9.7% vs 3.3%), and failure (6.5% vs 6.7%) were similar for the TVT and T.O.T. groups, respectively. The 1-year outcome data were collected in 29 women of the TVT group and 27 women of the T.O.T. group. No vaginal erosion occurred in either of the groups. In terms of bladder outlet obstruction, no differences were found after TVT and T.O.T. CONCLUSION: T.O.T. appears to be equally efficient as TVT for surgical treatment of stress urinary incontinence in women, with no reduction of bladder outlet obstruction at 1-year follow-up.