TY - JOUR T1 - Long-term outcomes of transobturator tapes in women with stress urinary incontinence: E-TOT randomised controlled trial. AU - Karmakar,D, AU - Mostafa,A, AU - Abdel-Fattah,M, PY - 2017/01/10/accepted PY - 2017/1/18/pubmed PY - 2018/12/12/medline PY - 2017/1/18/entrez KW - ARIS KW - TVT-O KW - stress urinary incontinence KW - tension-free vaginal tapes KW - transobturator tape SP - 973 EP - 981 JF - BJOG : an international journal of obstetrics and gynaecology JO - BJOG VL - 124 IS - 6 N2 - OBJECTIVE: To assess the long-term patient-reported outcomes and adverse events following surgery using transobturator tension-free vaginal tape (TO-TVT). DESIGN: Postal follow-up of the E-TOT randomised controlled trial (RCT). SETTING: A tertiary urogynaecology centre in the UK; all procedures took place in 2005-2007. POPULATION: 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. METHODS: Long-term follow-up (median 9 years) using validated symptom severity and quality-of-life (QoL) questionnaires. Statistical analysis was performed using spss 22.0 and GraphPad statistics 2014. MAIN OUTCOME MEASURES: 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). RESULTS: The adjusted response rate was 67.8% and the median follow-up period was 9.2 years. 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, OR 0.8676; 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. CONCLUSIONS: 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 9 years follow-up. The success rate is almost stable after 3 years. TWEETABLE ABSTRACT: The success rate for TO-TVT is 71% at 9 years, and is almost stable after 3 years; 8% required repeat surgery. SN - 1471-0528 UR - https://www.unboundmedicine.com/medline/citation/28094468/Long_term_outcomes_of_transobturator_tapes_in_women_with_stress_urinary_incontinence:_E_TOT_randomised_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -