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

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 controll...

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Bibliographic Details
Published in:International Urogynecology Journal 2013-09, Vol.24 (9), p.1459-1465
Main Authors: Bianchi-Ferraro, Ana Maria H. M., Jarmy-Di Bella, Zsuzsanna I. K., Castro, Rodrigo de A., Bortolini, Maria Augusta T., Sartori, Marair G. F., Girão, Manoel J. B. C.
Format: Article
Language:English
Subjects:
Adult
Aged
Female
Follow-Up Studies
Gynecologic Surgical Procedures - methods
Gynecology
Humans
Medicine
Medicine & Public Health
Middle Aged
Original Article
Prospective Studies
Quality of Life
Suburethral Slings - classification
Surveys and Questionnaires
Treatment Outcome
Urinary Incontinence, Stress - physiopathology
Urinary Incontinence, Stress - surgery
Urodynamics - physiology
Urology
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Summary: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  
ISSN:0937-3462
1433-3023
DOI:10.1007/s00192-012-1998-2