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

Martin Rudnicki, Katarina von Bothmer-Ostling, Anja Holstad, Claes Magnusson, Memona Majida, Constanze Merkel, Jens Prien, Ulf Jakobsson, Pia Teleman

Research output: Contribution to journalJournal articleResearchpeer-review

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.

Original languageEnglish
JournalActa Obstetricia et Gynecologica Scandinavica
Volume96
Issue number11
Pages (from-to)1347–1356
ISSN0001-6349
DOIs
Publication statusPublished - Nov 2017

Keywords

  • Journal Article
  • stress urinary incontinence
  • mid-urethral sling
  • single-incision mini-sling
  • standard mid-urethral slings
  • Mini-sling
  • Urinary Incontinence/therapy
  • Prospective Studies
  • Humans
  • Middle Aged
  • Pain, Postoperative
  • Treatment Outcome
  • Suburethral Slings
  • Sweden
  • Norway
  • Denmark
  • Quality of Life
  • Adult
  • Female
  • Pain Measurement

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    Rudnicki, M., von Bothmer-Ostling, K., Holstad, A., Magnusson, C., Majida, M., Merkel, C., Prien, J., Jakobsson, U., & Teleman, P. (2017). Adjustable mini-sling compared to conventional mid-urethral slings in women with urinary incontinence: A randomized controlled trial. Acta Obstetricia et Gynecologica Scandinavica, 96(11), 1347–1356. https://doi.org/10.1111/aogs.13205