Long-term efficacy and complications of a multicentre randomised controlled trial comparing Retropubic and Transobturator Mid-Urethral Slings: a prospective observational study.

Abstract

OBJECTIVE\nConcerns exist regarding the risks of mid-urethral slings (MUS) for stress urinary incontinence (SUI), particularly the lack of long-term data. We compare patient reported outcomes of a multicentre randomised controlled trial of retropubic (TVT-GYNECARETM ) versus transobturator (TOT-MONARCTM ) tape surgery at 12 years.\n\n\nDESIGN AND SETTING\nA multicentre study was performed in 11 tertiary referral centres.\n\n\nPOPULATION\nThe 180 participants from the original trial, the majority had mixed urinary incontinence.\n\n\nMETHODS\nPostal 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.\n\n\nMAIN OUTCOME MEASURES\ncomparison of the efficacy and complications between the TVT and TOT procedures in the long term.\n\n\nRESULTS\n110/180 responses were received: 55 TVT and 55 TOT. Mean follow up: 12.8 years, STD +/- 0.29 years. TVT was significantly superior to TOT ie no SUI: 41.8% TVT versus 21.8% TOT (p=0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% TVT and TOT respondents reported UUI. This was an improvement from baseline: 61.8% TVT and 76.4% TOT. 17 respondents had severe or moderate pain: 9(14.3%)TVT and 8(13.8%)TOT. 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI-I.\n\n\nCONCLUSIONS\nTVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. Severe vaginal or groin pain is uncommon. Careful patient counselling of long-term outcomes is required. The MUS appears to be an effective treatment for the majority of women with SUI.