Long-term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid-urethral slings: a prospective observational study

Objective: There are concerns regarding the risks of mid-urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long-term data. We compare patient-reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years. Design and setting: A multicentre study was performed in 11 tertiary referral centres. Population: A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence. Methods: Postal questionnaire survey of patient-reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI-I) and a numeric rating scale pain questionnaire. Main outcome measures: Comparison of the efficacy and complications between the TVT and TOT procedures in the long term. Results: A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow-up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI-I. Conclusions: TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long-term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI. Tweetable abstract: Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.