Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial

Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial

Author Bianchi-Ferraro, Ana Maria H. M. Autor UNIFESP Google Scholar
Jarmy-Di Bella, Zsuzsanna I. K. Autor UNIFESP Google Scholar
Castro, Rodrigo de A. Autor UNIFESP Google Scholar
Bortolini, Maria Augusta T. Autor UNIFESP Google Scholar
Sartori, Marair G. F. Autor UNIFESP Google Scholar
Girao, Manoel J. B. C. Autor UNIFESP Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Abstract 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).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).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).TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.
Keywords Minisling
Single-incision sling
Stress urinary incontinence
SUI surgery
Transobturator sling
Language English
Sponsor Federal University of São Paulo
Date 2013-09-01
Published in International Urogynecology Journal. London: Springer London Ltd, v. 24, n. 9, p. 1459-1465, 2013.
ISSN 0937-3462 (Sherpa/Romeo, impact factor)
Publisher Springer
Extent 1459-1465
Access rights Closed access
Type Article
Web of Science ID WOS:000323432600007

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