| Treatment success of retropubic and transobturator mid urethral slings at 24 months. | |
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MedLine Citation:
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PMID: 23083653 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural Date: 2012-10-22 |
Journal Detail:
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Title: The Journal of urology Volume: 188 ISSN: 1527-3792 ISO Abbreviation: J. Urol. Publication Date: 2012 Dec |
Date Detail:
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Created Date: 2012-11-12 Completed Date: 2013-01-22 Revised Date: 2013-04-23 |
Medline Journal Info:
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Nlm Unique ID: 0376374 Medline TA: J Urol Country: United States |
Other Details:
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Languages: eng Pagination: 2281-7 Citation Subset: AIM; IM |
Copyright Information:
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Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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University of California, San Diego, La Jolla, California, USA. malbo@ucsd.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Female Follow-Up Studies Humans Remission Induction Suburethral Slings* / adverse effects Time Factors Urinary Incontinence, Stress / surgery* |
| Grant Support | |
ID/Acronym/Agency:
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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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