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Tension-Free Vaginal Tape-O and -Secur for the Treatment of Stress Urinary Incontinence: A Thirty-six-Month Follow-Up Single-Blind, Double-Arm, Randomized Study.
MedLine Citation:
PMID:  23352582     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To compare the efficacy of the inside-out tension-free vaginal tape-obturator (TVT-O) device versus the single-incision TVT-Secur device 36 months after the procedure. METHODS: A single-blind, randomized, parallel-group study on 154 patients with stress urinary incontinence (77 treated with TVT-O and 77 with the TVT-Secur hammock approach). The primary endpoint was the objective cure rate 36 months after the procedure evaluated with the challenge stress test. Secondary endpoints were subjective cure rate (evaluated with bladder diary, quality-of-life questionnaires, and patient-reported outcome tools) and intraoperative and postoperative complications. The primary endpoint was evaluated with a noninferiority study design. RESULTS: Sixty-six patients in the TVT-O group and 64 in the TVT-Secur group concluded the study. Thirty-six months after the procedure, 57/66 patients (86.4%) in the TVT-O and 50/64 (78.1%) in the TVT-Secur groups were objectively cured (noninferiority unilateral u test: p < .05). No differences were observed in the subjective cure and complication rates. CONCLUSIONS: TVT-Secur seems not to be inferior to TVT-O in the surgical treatment of stress urinary incontinence and causes less postoperative pain. The possibility of severe blood loss cannot be ruled out when TVT-Secur is used.
Authors:
Giovanni A Tommaselli; Alessandro D'Afiero; Costantino Di Carlo; Carmen Formisano; Annamaria Fabozzi; Carmine Nappi
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-23
Journal Detail:
Title:  Journal of minimally invasive gynecology     Volume:  -     ISSN:  1553-4669     ISO Abbreviation:  J Minim Invasive Gynecol     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101235322     Medline TA:  J Minim Invasive Gynecol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Obstetrics and Gynecology - University of Naples "Federico II", Naples, Italy. Electronic address: gtommaselli@yahoo.it.
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