INTRODUCTION AND HYPOTHESIS: Despite established comparable efficacy between retropubic midurethral (RMUS) and transobturator slings, there are conflicting data regarding single-incision mini-slings (SIMS).
This study tests the null hypothesis that the MiniArc® Single-Incision Sling is equivalent to the ALIGN® Urethral Support System for treatment of stress urinary incontinence (SUI).
METHODS: Women who underwent a sling for SUI from 1 January 2008 through 31 December 2009 were identified (N = 324). A follow-up survey was mailed. Primary outcomes were treatment failure, defined as International Consultation on Incontinence Questionnaire (ICIQ) score >0 or additional anti-incontinence procedure, and stress-specific incontinence (SSI). Secondary outcomes included Patient Global Impression of Severity and Improvement (PGI-SI), satisfaction, de novo urge, and complications.
RESULTS: The study included 202 women who returned the survey. The SIMS group had higher body mass index (BMI) (30.7 ± 6.5 vs 28.9 ± 6.0 kg/m2, P = 0.052) and shorter follow-up (18.6 ± 11.5 vs 22.9 ± 14.6 months, P = 0.019). Treatment failure was higher in SIMS compared with RMUS (76.3 % vs 64.2 %) with adjusted odds ratio of 1.84 (95 % CI, 1.0, 3.5). The SIMS group was more likely to have postoperative SSI, with adjusted OR of 2.4 (95 % CI; 1.3-4.5). The RMUS group reported more improvement and satisfaction. Incidence of de novo urge and complications were similar between groups. Reoperation for mesh erosion was more likely in the RMUS group, while the SIMS had a higher reoperation rate for SUI.
CONCLUSIONS: Compared with retropubic ALIGN® Slings, MiniArc®Single-Incision Slings are less effective, with more postoperative incontinence, less patient-reported improvement, satisfaction, and higher reoperation rates for SUI.
Written by:
Madsen AM, El-Nashar SA, Woelk JL, Klingele CJ, Gebhart JB, Trabuco EC. Are you the author?
Division of Gynecologic Surgery, Mayo Clinic, Rochester, MN, USA.
Reference: Int Urogynecol J. 2013 Sep 17. Epub ahead of print.
doi: 10.1007/s00192-013-2208-6
PubMed Abstract
PMID: 24043128
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