Introduction and hypothesisThe tension-free vaginal tape (TVT) and inside-out transobturator tape (TVT-O) are first-line surgical treatments for stress urinary incontinence (SUI). However, there is a lack of information regarding the long-term comparative safety of these procedures.MethodsA total of 140 SUI patients were randomized to the TVT or TVT-O procedure and were interviewed by an independent investigator at the follow-up. The primary outcomes were the proportions of patients with long-term postoperative complications. The secondary outcomes included the cure rates, quality of life (QOL) and sexual function based on validated questionnaires.ResultsOne hundred and twenty (85.71 %) patients completed the long-term follow-up. More TVT patients experienced perioperative complications (P?0.05). However, in a mean follow-up of 95 months, no significant between-group difference was found in the proportions of patients with long-term complications or in the variety of reported complications. The long-term complication rates for TVT and TVT-O were 43.1 % and 27.4 % respectively (P?=?0.07). De novo voiding (15.8 %) and storage symptoms (10.8 %) were the primary long-term complications. Tape exposure was possible up to 7 years after TVT-O. The objective cure rates of TVT and TVT-O procedures were 79.30 and 69.35 % respectively, which were not significantly higher than the subjective rates. The Pelvic Floor Impact Questionnaire (PFIQ-7) scores remained improved (P?0.001) after both procedures, even at the 95-month follow-up. No difference was observed in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short Form (PISQ-12) scores after either procedure.ConclusionsIn the long term, the proportion of patients with complications and the cure rates of the two procedures did not differ significantly. The long-term complication rates were high, but morbidity was low, and the QOL remained improved. |