Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial

Research output: Contribution to journalArticle

Abstract

Introduction: The primary aim of this study was to compare the objective and subjective outcomes and short-term complication rates of an adjustable single-incision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS). The secondary aim was to report pain perception and complications at the one-year follow up. Material and methods: The study was designed as a multicenter prospective randomized trial where women were included from eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials.gov: NCT01754558. A total of 305 women less than 60 years old with verified stress urinary incontinence were included. All women were randomized to SIMS (Ajust®; n = 155) or SMUS (TVT, TVT-O or TOT; n = 150) and were evaluated by stress test and bladder diary before and after surgery and symptoms related to incontinence using ICIQ-SF, PISQ-12 and PGI-S and PGI-I. Objective cure was defined as no leakage during a stress test and subjective cure defined as no leakage stated in the bladder diary or no indication of urinary leakage in the ICIQ-SF. Furthermore, mesh exposure and dyspareunia were recorded. Results: In total, 280 women [141 (91%) in the SIMS and 139 (94%) in the SMUS groups) participated in the one-year follow up. No difference between the groups was observed regarding objective and subjective outcomes. VAS score disclosed a lower postoperative pain perception in the SIMS group than in the SMUS group. Conclusions: Ajust® appears to be as efficient as SMUS regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period.

Details

Authors
  • Martin Rudnicki
  • Katarina von Bothmer-Ostling
  • Anja Holstad
  • Claes Magnusson
  • Memona Majida
  • Constanze Merkel
  • Jens Prien
  • Ulf Jakobsson
  • Pia Teleman
Organisations
External organisations
  • Odense University Hospital
  • Sahlgrenska University Hospital
  • Oslo university hospital
  • Skåne University Hospital
  • Halmstad County Hospital
  • Gjøvik Hospital
  • Aalborg University Hospital
  • Zealand University Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Obstetrics, Gynecology and Reproductive Medicine

Keywords

  • Mid-urethral sling, Mini-sling, Single-incision mini-sling, Standard mid-urethral slings, Stress urinary incontinence
Original languageEnglish
Pages (from-to)1347-1356
JournalActa Obstetricia et Gynecologica Scandinavica
Volume96
Issue number11
Early online date2017
Publication statusPublished - 2017
Publication categoryResearch
Peer-reviewedYes