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

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Abstract

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.

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Authors and Affiliations

  1. 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

    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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  1. Ana Maria H. M. Bianchi-Ferraro
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  2. Zsuzsanna I. K. Jarmy-Di Bella
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  3. Rodrigo de A. Castro
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  4. Maria Augusta T. Bortolini
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  5. Marair G. F. Sartori
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  6. Manoel J. B. C. Girão
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Corresponding author

Correspondence to Ana Maria H. M. Bianchi-Ferraro.

Additional information

Registration: Clinical Trials.gov Protocol Registration System, http://www.clinicaltrials.gov, NCT 01095159, TVTO™ X TVTS ™ for Treatment of Stress Urinary Incontinence

Funded by Federal University of São Paulo

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Bianchi-Ferraro, A.M.H.M., Jarmy-Di Bella, Z.I.K., Castro, R.d.A. et al. Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. Int Urogynecol J 24, 1459–1465 (2013). https://doi.org/10.1007/s00192-012-1998-2

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  • DOI: https://doi.org/10.1007/s00192-012-1998-2

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