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.
(Less)
- author
- Rudnicki, Martin
; von Bothmer-Ostling, Katarina
; Holstad, Anja
; Magnusson, Claes
; Majida, Memona
; Merkel, Constanze
; Prien, Jens
; Jakobsson, Ulf
LU
and Teleman, Pia
LU
- organization
- publishing date
- 2017
- 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
- pmid:28815547
- 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
- 2025-04-04 15:02:41
@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}},
keywords = {{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}},
doi = {{10.1111/aogs.13205}},
volume = {{96}},
year = {{2017}},
}