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

Rudnicki, Martin; von Bothmer-Ostling, Katarina; Holstad, Anja; Magnusson, Claes; Majida, Memona; Merkel, Constanze; Prien, Jens; Jakobsson, Ulf LU and Teleman, Pia LU (2017) In Acta Obstetricia et Gynecologica Scandinavica 96(11). p.1347-1356
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)... (More)

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.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Mid-urethral sling, Mini-sling, Single-incision mini-sling, Standard mid-urethral slings, Stress urinary incontinence
in
Acta Obstetricia et Gynecologica Scandinavica
volume
96
issue
11
pages
1347 - 1356
publisher
Wiley-Blackwell
external identifiers
  • scopus:85029545000
  • wos:000417432200010
ISSN
0001-6349
DOI
10.1111/aogs.13205
language
English
LU publication?
yes
id
2e18ee4d-ce6f-49a6-9380-f0406c0dd1ab
date added to LUP
2017-10-10 08:52:33
date last changed
2018-01-16 13:22:19
@article{2e18ee4d-ce6f-49a6-9380-f0406c0dd1ab,
  abstract     = {<p>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<sup>®</sup>; 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<sup>®</sup> appears to be as efficient as SMUS regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period.</p>},
  author       = {Rudnicki, Martin and von Bothmer-Ostling, Katarina and Holstad, Anja and Magnusson, Claes and Majida, Memona and Merkel, Constanze and Prien, Jens and Jakobsson, Ulf and Teleman, Pia},
  issn         = {0001-6349},
  keyword      = {Mid-urethral sling,Mini-sling,Single-incision mini-sling,Standard mid-urethral slings,Stress urinary incontinence},
  language     = {eng},
  number       = {11},
  pages        = {1347--1356},
  publisher    = {Wiley-Blackwell},
  series       = {Acta Obstetricia et Gynecologica Scandinavica},
  title        = {Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial},
  url          = {http://dx.doi.org/10.1111/aogs.13205},
  volume       = {96},
  year         = {2017},
}