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Int Urogynecol J. 2014 Oct;25(10):1333-41. doi: 10.1007/s00192-014-2383-0. Epub 2014 Apr 16.

A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence.

Author information

1
Obstetrics and Gynecology Unit, Department of Obstetrics, Gynecology and Pediatrics, Azienda Ospedaliera "Santa Maria Nuova" - Istituto di Ricovero e Cura a Carattere Scientifico of Reggio Emilia, Reggio Emilia, Italy, stefanopalomba@tin.it.

Abstract

INTRODUCTION AND HYPOTHESIS:

Studies have observed a significant heterogeneity in efficacy data for single-incision minislings (SIMS) as surgical treatment for female urinary incontinence (UI). Our study aim was to test the hypothesis that different vaginal kits for SIMS have different long-term outcomes.

METHODS:

One hundred and twenty women with stress (SUI) or mixed (MUI) UI were enrolled in a multicenter randomized clinical trial (registration number NCT00751088) and treated with three different SIMS (Ajust, MiniArc, or TVT Secur System). Duration of follow-up was at least 24 months from surgery. The primary outcome was the subjective cure rate at 24 months from surgery; secondary outcomes were rates of total failure and reoperations for UI.

RESULTS:

At study end, no difference was detected between groups in terms of total subjective cure rate [21 (52.5%) vs. 26 (65.0%) vs. 21 (52.5%), in Ajust, MiniArc, and TVT Secur System group, respectively; P = 0.412] or in terms of total failure rate [24 (60.0%) vs. 22 (55.0 %) vs. 27 (67.5 %), in Ajust, MiniArc, and TVT Secur System group, respectively; P = 0.432]. The proportion of patients who received a second surgery for UI was also not significantly different between groups [13 (32.5%) vs. 10 (25.0%) vs. 13 (32.5%), in Ajust, MiniArc, and TVT Secur System, respectively; P = 0.831].

CONCLUSION:

The long-term efficacy of SIMS does not differ between the vaginal kits examined.

PMID:
24737301
DOI:
10.1007/s00192-014-2383-0
[Indexed for MEDLINE]

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