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 language | English |
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Journal | Acta Obstetricia et Gynecologica Scandinavica |
Volume | 96 |
Issue number | 11 |
Pages (from-to) | 1347–1356 |
ISSN | 0001-6349 |
DOIs | |
Publication status | Published - 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