Document Detail


Treatment success of retropubic and transobturator mid urethral slings at 24 months.
MedLine Citation:
PMID:  23083653     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: Longer term comparative efficacy information regarding transobturator and retropubic mid urethral slings is needed. We report 24-month continence rates, complications and symptom outcomes from a randomized equivalence trial.
MATERIALS AND METHODS: Primary outcomes were objective (negative stress test, negative pad test and no re-treatment for stress urinary incontinence) and subjective (no self-report of stress urinary incontinence symptoms, no leakage episodes on 3-day bladder diary and no re-treatment for stress urinary incontinence) success at 24 months. The predetermined equivalence margin was ± 12%.
RESULTS: Of 597 randomized participants 516 (86.4%) were assessed. Objective success rates for retropubic and transobturator mid urethral slings were 77.3% and 72.3%, respectively (95% CI for difference of 5.1% was -2.0, 12.1), and subjective success rates were 55.7% and 48.3%, respectively (CI for difference of 7.4% was -0.7, 15.5). Neither objective nor subjective success rates met the prespecified criteria for equivalence. Patient satisfaction (retropubic 86.3% vs transobturator 88.1%, p = 0.58), frequency of de novo urgency incontinence (retropubic 0% vs transobturator 0.3%, p = 0.99) and occurrence of mesh exposure (retropubic 4.4% vs transobturator 2.7%, p = 0.26) were not significantly different. The retropubic mid urethral sling group had higher rates of voiding dysfunction requiring surgery (3.0% vs 0%, p = 0.002) and urinary tract infections (17.1% vs 10.7%, p = 0.025), whereas the transobturator group had more neurological symptoms (9.7% vs 5.4%, p = 0.045).
CONCLUSIONS: Objective success rates met the criteria for equivalence at 12 months but no longer met these criteria at 24 months. Subjective success rates remained inconclusive for equivalence. Patient satisfaction remained high and symptom severity remained markedly improved. Continued surveillance is important in women undergoing mid urethral sling surgery.
Authors:
Michael E Albo; Heather J Litman; Holly E Richter; Gary E Lemack; Larry T Sirls; Toby C Chai; Peggy Norton; Stephen R Kraus; Halina Zyczynski; Kimberly Kenton; E Ann Gormley; John W Kusek;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-10-22
Journal Detail:
Title:  The Journal of urology     Volume:  188     ISSN:  1527-3792     ISO Abbreviation:  J. Urol.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-12     Completed Date:  2013-01-22     Revised Date:  2013-04-23    
Medline Journal Info:
Nlm Unique ID:  0376374     Medline TA:  J Urol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2281-7     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
Affiliation:
University of California, San Diego, La Jolla, California, USA. malbo@ucsd.edu
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MeSH Terms
Descriptor/Qualifier:
Female
Follow-Up Studies
Humans
Remission Induction
Suburethral Slings* / adverse effects
Time Factors
Urinary Incontinence, Stress / surgery*
Grant Support
ID/Acronym/Agency:
U01 DK060380/DK/NIDDK NIH HHS; U01 DK58225/DK/NIDDK NIH HHS; U01 DK58229/DK/NIDDK NIH HHS; U01 DK58231/DK/NIDDK NIH HHS; U01 DK58234/DK/NIDDK NIH HHS; U01 DK60379/DK/NIDDK NIH HHS; U01 DK60380/DK/NIDDK NIH HHS; U01 DK60393/DK/NIDDK NIH HHS; U01 DK60395/DK/NIDDK NIH HHS; U01 DK60397/DK/NIDDK NIH HHS; U01 DK60401/DK/NIDDK NIH HHS

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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