Long-term outcomes of transobturator tapes in women with stress urinary incontinence: E-TOT randomised controlled trial.

Abstract

To assess the long-term patient-reported outcomes and adverse events following surgery using transobturator tension-free vaginal tape (TO-TVT). Postal follow-up of the E-TOT randomised controlled trial (RCT). A tertiary urogynaecology centre in the UK; all procedures took place in 2005-2007. A total of 341 women were randomised to receive either 'inside-out' TVT-O (Ethicon Inc., Somerville, NJ, USA) or 'outside-in' TOT-ARIS (Coloplast Corp., Minneapolis, MN, USA) procedure. Long-term follow-up (median 9years) using validated symptom severity and quality-of-life (QoL) questionnaires. Statistical analysis was performed using spss22.0 and GraphPad statistics2014. The primary outcome was patient-reported success rate, defined as 'very much/much improved' on the Patient's Global Impression of Improvement (PGI-I) scale. Secondary outcomes included impact on women's QoL and sexual function, adverse events, and re-operations for stress urinary incontinence (SUI). The adjusted response rate was 67.8% and the median follow-up period was 9.2years. The overall patient-reported success rate was 71.6%, with a further 14% reporting 'improvement', and there was no significant difference between inside-out and outside-in groups (P=0.76; odds ratio, OR0.8676; 95% confidence interval, 95%CI 0.4744-1.5865). The success rate showed a significant reduction compared with 1-year results (71.6 versus 80%; P=0.004), but a clinically insignificant reduction when compared with the 3-year results (71.6 versus 73.1%). A total of 7.96% underwent further continence surgery, the tape extrusion/erosion rate was 4.5%, and groin pain/discomfort was reported in 4.32%, with only 1.4% requiring treatment. This is the largest and longest follow-up randomised trial of TO-TVT. TO-TVT is associated with 71.6% patient-reported success rate, 4% groin pain/discomfort, and 8% continence re-operation rate at a median of 9years follow-up. The success rate is almost stable after 3years. The success rate for TO-TVT is 71% at 9years, and is almost stable after 3years; 8% required repeat surgery.