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

Objectives
To assess the long-term (LT) patient-reported outcomes and adverse events(AE) following transobturator tension-free vaginal tape(TO-TVT).
Design
Postal follow-up of the E-TOT randomised controlled trial(RCT).
Setting
A tertiary urogynaecology center in the UK; all procedures took place in 2005 to2007.
Population
341 Women were randomised to undergo either “inside-out” TVT-O (Ethicon Inc.,Somerville,NJ,USA) or “outside-in” TOT-ARIS (Coloplast Corp., Minneapolis,MN,USA).
Methods
Long-term (median 9-years) follow-up, using validated symptom severity and Qol questionnaires. Statistical analysis was performed using SPSS v22.0(IBM Corp.,Armonk, NY,USA) and GraphPad Statistics-2014.
Main Outcome Measures
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 SUI.
Results
The adjusted-response rate was 67.8%; median follow-up was 9.2-years. The overall patient-reported success rate was 71.6% with further 14% reporting “improvement”; and no significant difference between inside-out and outside-in groups (p=0.76,OR:0.8676, 95%CI:0.4744,1.5865). The success rate showed significant reduction compared to 1-year results (71.6%vs.80%; p=0.004) but clinically insignificant reduction when compared to the 3-years (71.6%vs.73.1%). A total of 7.96% underwent further continence surgery; tape extrusion/ erosion rate was 4.5%; groin pain/discomfort was reported in 4.32% with only 1.4% requiring treatment.
Conclusions
This is the largest and longest follow-up randomized 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 median of 9-years follow-up. The success rate is almost stable after 3-years.