Cargando…

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. METHODS: This study was designed as a multicenter pr...

Descripción completa

Detalles Bibliográficos
Autores principales: Alexandridis, Vasileios, Rudnicki, Martin, Jakobsson, Ulf, Teleman, Pia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6706362/
https://www.ncbi.nlm.nih.gov/pubmed/31222572
http://dx.doi.org/10.1007/s00192-019-04004-w
_version_ 1783445684493484032
author Alexandridis, Vasileios
Rudnicki, Martin
Jakobsson, Ulf
Teleman, Pia
author_facet Alexandridis, Vasileios
Rudnicki, Martin
Jakobsson, Ulf
Teleman, Pia
author_sort Alexandridis, Vasileios
collection PubMed
description INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. METHODS: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. RESULTS: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. CONCLUSIONS: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.
format Online
Article
Text
id pubmed-6706362
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-67063622019-09-06 Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial Alexandridis, Vasileios Rudnicki, Martin Jakobsson, Ulf Teleman, Pia Int Urogynecol J Original Article INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. METHODS: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. RESULTS: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. CONCLUSIONS: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes. Springer International Publishing 2019-06-20 2019 /pmc/articles/PMC6706362/ /pubmed/31222572 http://dx.doi.org/10.1007/s00192-019-04004-w Text en © The Author(s) 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article
Alexandridis, Vasileios
Rudnicki, Martin
Jakobsson, Ulf
Teleman, Pia
Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial
title Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial
title_full Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial
title_fullStr Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial
title_full_unstemmed Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial
title_short Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial
title_sort adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6706362/
https://www.ncbi.nlm.nih.gov/pubmed/31222572
http://dx.doi.org/10.1007/s00192-019-04004-w
work_keys_str_mv AT alexandridisvasileios adjustableminislingcomparedwithconventionalmidurethralslingsinwomenwithurinaryincontinencea3yearfollowupofarandomizedcontrolledtrial
AT rudnickimartin adjustableminislingcomparedwithconventionalmidurethralslingsinwomenwithurinaryincontinencea3yearfollowupofarandomizedcontrolledtrial
AT jakobssonulf adjustableminislingcomparedwithconventionalmidurethralslingsinwomenwithurinaryincontinencea3yearfollowupofarandomizedcontrolledtrial
AT telemanpia adjustableminislingcomparedwithconventionalmidurethralslingsinwomenwithurinaryincontinencea3yearfollowupofarandomizedcontrolledtrial