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.