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The Virtue Sling-A New Quadratic Sling for Postprostatectomy Incontinence-Results of a Multinational Clinical Trial.
MedLine Citation:
PMID:  24972946     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial "unfixed" sling trial.
METHODS: A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of "much" or "very much" better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (<100 g), moderate (100-400 g), and severe (>400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel "fixation" technique was performed, with similar outcome measures.
RESULTS: In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events.
CONCLUSION: The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening.
Authors:
Craig V Comiter; Eugene Y Rhee; Le-Mai Tu; Sender Herschorn; Victor W Nitti
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-6-25
Journal Detail:
Title:  Urology     Volume:  -     ISSN:  1527-9995     ISO Abbreviation:  Urology     Publication Date:  2014 Jun 
Date Detail:
Created Date:  2014-6-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366151     Medline TA:  Urology     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2014 Elsevier Inc. All rights reserved.
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