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

作者：Palomba Stefano^*; Falbo Angela; Oppedisano Rosamaria; Torella Marco; Materazzo Caterina; Maiorana Antonio; Tolino Achille; Mastrantonio Pasquale; La Sala Giovanni Battista; Alio Luigi; Colacurci Nicola; Zullo Fulvio

来源：International Urogynecology Journal and Pelvic Floor Dysfunction, 2014, 25(10): 1333-1341.

DOI：10.1007/s00192-014-2383-0

• Incontinence
• Sling
• Single-incision minislings
• Surgery
• Randomized controlled trial
• Treatment

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. %26lt;br%26gt;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(A (R)), MiniArc(A (R)), or TVT Secur System(A (R))). 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. %26lt;br%26gt;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(A (R)), MiniArc(A (R)), and TVT Secur System(A (R)) 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(A (R)), MiniArc(A (R)), and TVT Secur System(A (R)) 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(A (R)), MiniArc(A (R)), and TVT Secur System(A (R)), respectively; P = 0.831]. %26lt;br%26gt;The long-term efficacy of SIMS does not differ between the vaginal kits examined.

• 出版日期2014-10