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.
Written by:
Palomba S, Falbo A, Oppedisano R, Torella M, Materazzo C, Maiorana A, Tolino A, Mastrantonio P, La Sala GB, Alio L, Colacurci N, Zullo F. Are you the author?
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.
Reference: Int Urogynecol J. 2014 Apr 16. Epub ahead of print.
doi: 10.1007/s00192-014-2383-0
PubMed Abstract
PMID: 24737301
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