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.
RCT Entities:
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.
Authors: Matthew D Barber; Alison C Weidner; Andrew I Sokol; Cindy L Amundsen; J Eric Jelovsek; Mickey M Karram; Mark Ellerkmann; Charles R Rardin; Cheryl B Iglesia; Marc Toglia Journal: Obstet Gynecol Date: 2012-02 Impact factor: 7.661
Authors: Piet Hinoul; Harry A M Vervest; Jan den Boon; Pieter L Venema; Marielle M Lakeman; Alfredo L Milani; Jan-Paul W R Roovers Journal: J Urol Date: 2011-02-22 Impact factor: 7.450
Authors: G Ghoniem; E Stanford; K Kenton; C Achtari; R Goldberg; T Mascarenhas; M Parekh; K Tamussino; S Tosson; G Lose; E Petri Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2007-11-17
Authors: Juan Gambini-Ricapa; Javier García-Oms; Miguel Barea; Angeles Estrada; Alejandra Iturri; Juan Gambini-Buchon; Juan Gilabert-Estelles Journal: Int Urogynecol J Date: 2016-02-10 Impact factor: 2.894