Transobturator versus single incision slings: 1-year results of a randomized controlled trial.

Abstract

To compare 1-year surgical outcomes following transobturator (TO) sling placement and single incision (SI) sling placement for the treatment of stress urinary incontinence (SUI). We performed a randomized trial at a single institution. Patients with urodynamically proven SUI were offered participation and randomized to placement of a TO sling (Monarc™) or a SI sling (MiniArc™) between 2008 and 2011. The primary outcome measure was urinary leakage during standardized cough stress test (CST). Forty subjects in each group were required to achieve 80% power to detect an effect size of 0.25. A total of 98 patients were randomized with 49 patients in the TO group and 49 patients in the SI group. Preoperative demographics were similar between the groups (Table 1). The TO group had a significantly longer sling operative time (10.7 ± 4.8 min vs. 7.8 ± 4.9 min, p < 0.001) and greater estimated blood loss (31.6 ± 26.6 mL vs. 22.9 ± 22.1 mL, p = 0.02). At the 1-year follow-up, there was no difference in the primary outcome with 9 TO patients (21%) and 12 SI patients (29%) having a positive CST (p = 0.5). A composite measurement of 'failure', defined as patient-reported SUI and a positive CST, showed no difference between the TO group (17%) and the SI group (27%; p = 0.3). The SI sling provides comparable objective efficacy to the TO sling at 1year.