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Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial.
MedLine Citation:
PMID:  23208003     Owner:  NLM     Status:  Publisher    
INTRODUCTION AND HYPOTHESIS: We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). METHODS: This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King's Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p < 0.05). RESULTS: Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) -15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI -11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p < 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p < 0.001). CONCLUSION: TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.
Ana Maria H M Bianchi-Ferraro; Zsuzsanna I K Jarmy-Di Bella; Rodrigo de A Castro; Maria Augusta T Bortolini; Marair G F Sartori; Manoel J B C Girão
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-4
Journal Detail:
Title:  International urogynecology journal     Volume:  -     ISSN:  1433-3023     ISO Abbreviation:  Int Urogynecol J     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101567041     Medline TA:  Int Urogynecol J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Sector of Urogynecology and Vaginal Surgery, Department of Gynecology, Federal University of São Paulo, Alameda Jaú 759, apt 71, São Paulo, SP, Brazil, 01420-001,
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