Retropubic tension-free vaginal tape and inside-out transobturator tape: a long-term randomized trial

Int Urogynecol J. 2016 Jan;27(1):103-11. doi: 10.1007/s00192-015-2798-2. Epub 2015 Aug 12.

Abstract

Introduction and hypothesis: The 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.

Methods: A 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.

Results: One 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.

Conclusions: In 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.

Keywords: Complications; Inside-out transobturator tape; Long-term follow-up; Randomized controlled trial; Stress urinary incontinence; Tension-free vaginal tape.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Female
  • Humans
  • Middle Aged
  • Prospective Studies
  • Prosthesis Design
  • Suburethral Slings* / adverse effects
  • Surveys and Questionnaires
  • Time Factors
  • Urinary Incontinence, Stress / surgery*

Associated data

  • ChiCTR/CHICTR-TRC-14004371