Evaluation of transobturator tapes (E-TOT) study: randomised prospective single-blinded study comparing inside-out vs. outside-in transobturator tapes in management of urodynamic stress incontinence: short term outcomes.

Objectives: To compare the "inside-out (TVT-O)" vs. "outside-in (ARIS)" transobturator tapes in the management of female urodynamic stress incontinence (USI) and to identify independent risk factors of failure of transobturator tapes.

Study Design: A prospective, single blinded, randomised trial. Women undergoing transobturator tapes as sole procedure in the period April 2005 and April 2007 were randomised to TVT-O for the inside-out approach and TOT-ARIS for the outside-in approach. The primary outcome measure at 6 months was the absence of USI on urodynamics. Secondary outcomes included; patient-reported success rates, overall patient satisfaction and peri-operative complications.

Results: 341 women were recruited: 171 in the outside-in group and 170 in the inside-out. Severe post-operative thigh pain was twice as common in the inside-out group but this was not statistically significant (6.7% vs. 3.5%, p=0.19). 317 women completed the 6 months follow-up; objective cure rates and patient-reported success rates were 85.4 and 80.5%, respectively, with no significant difference between the groups (p=0.28 and p=0.138, respectively). On multivariate analysis: low maximum urethral closure pressure (MUCP) (<30 cm H2O) and previous incontinence surgery were confirmed as independent risk factors for objective failure of transobturator tape with increased odds of failure of 7.06 (2.85-17.48) and 6.22 (2.34-16.52), respectively.

Conclusion: This study shows no significant differences in the objective cure rates and patient-reported success rates between the "inside-out (TVT-O)" and "outside-in (ARIS)" transobturator tape procedures in the management of female USI at 6 months follow-up. Previous incontinence surgery and low MUCP were significant risk factors for failure of transobturator tapes.