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

The primary aim was to compare the objective and subjective outcomes and short-term complication rates of an adjustable single-incision mini-sling (SIMS) versus standard mid-urethral slings (SMUS). The secondary aim was reporting pain perception and complications at one-year follow-up.

The study was designed as a multicenter prospective randomized trial where women were included by 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.

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 compared to the SMUS group.

Ajust(®) appears to be as efficient as SMUS regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period. This article is protected by copyright. All rights reserved.

Acta obstetricia et gynecologica Scandinavica. 2017 Aug 16 [Epub ahead of print]

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

Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark., Department of Obstetrics and Gynecology, Halmstad Hospital, Halmstad, Sweden., Department of Obstetrics and Gynecology, Gjøvik Hospital, Gjøvik, Norway., Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden., Department of Obstetrics and Gynecology, Ahus University Hospital, Oslo, Norway., Department of Obstetrics and Gynecology, Regional Hospital of Northern Jutland, Frederikshavn, Denmark., Department of Obstetrics and Gynecology, Zealand Hospital, Nykøbing Falster, Denmark., Center for Primary Healthcare Research, Faculty of Medicine, University of Lund, Lund, Sweden., Department of Obstetrics and Gynecology, Skåne University Hospital, Lund University, Lund, Sweden.

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