Tension-free vaginal tape versus transobturator tape as surgery for stress urinary incontinence: results of a multicentre randomised trial.

OBJECTIVES: This prospective, multicentre, randomised study compared the safety and success rate of tension-free vaginal tape (TVT) and transobturator tape (TOT) in treatment of female stress urinary incontinence.

METHODS: Of 148 women, 73 were randomised to TVT and 75 to TOT. Preoperative workups included case history, clinical examination, Urogenital Distress Inventory and Impact Incontinence Quality of life questionnaires, 1-h pad test, pelvic ultrasound, and urodynamics. Intra- and postoperative complications were the primary end point; subjective and objective changes in SUI, and postoperative voiding dysfunctions were secondary end points. Patients were classified into two main categories: dry (no leakage during clinical and/or stress test and/or reported by patients) versus wet. Patients who referred being wet were separated into "improved" or "failure" on subjective analysis. Other outcome variables were quality of life questionnaires and VAS scale. Clinical checkups were conducted at 3, 6, 12 mo, and then annually.

RESULTS: Both techniques are safe and no significant differences emerged in intra- and postoperative complications. At a mean follow-up of 31 mo, the overall objective cure (dry) was 71.4% for TVT and 77.3% for TOT (p=ns). When one considered "dry" plus "wet but improved," these values increased to 90% and 90.6%, respectively (p=ns). Median satisfaction rate was 9 (range: 1-10) for both procedures. Postoperative storage symptoms are a controversial issue; they persisted in 44% of patients in TVT group versus 24% in TOT group (p<0.053).

CONCLUSIONS: TOT appears as safe and effective as TVT in surgery for female SUI, with minimal complications at mean follow-up of 31 mo.