ntroduction and hypothesis The purpose of this study is to
compare retropubic tension-free vaginal tape (TVT) with
transobturator out-in TOT and in-out TVT-O for female stress urinary incontinence. Uroflow rate was primary;
continence rates, quality of life (QoL) and complication
pattern were secondary endpoints.
Methods: A prospective randomised trial with 2:1:1 randomisation at two Swiss teaching hospitals. Patients were
followed up at 12 months.
Results Eighty TVT, 40 transobturator tape (TOT) and 40 TVT-O were randomised. At 12 months, there was no difference in Qmax among the groups. Continence was comparable (≥89%). QoL was improved significantly in all groups (P<0.05). Five vaginal tape exposures occurred (one TVT, four TOT, zero TVT-O; P=0.028). Two percent (1/52) of sexually active patients after TVT, 17% (5/29) after TOT, but 0% (0/25) after TVTO reported de novo female sexual dysfunction (P=0.011). We considered this clinically important enough to stop enrolment. Conclusions There was no difference for Qmax at 12 months between TVT, TOT and TVT-O. Female sexual dysfunction and tape exposure may be higher with a transobturator tape.