Randomized controlled trial comparing single-incision mini-sling and transobturator midurethral sling for the treatment of stress urinary incontinence: 3-year follow-up results

BackgroundThe role of single-incision mini-slings (SIMS) in stress urinary incontinence (SUI) management is still not elucidated. ObjectiveTo compare efficacy and safety of SIMS and transobturator sling (TOT) for SUI after 36-month follow-up. MethodsA randomized controlled clinical trial involving 130 women with SUI that had either SIMS or TOT. Primary outcomes: objective cure defined as negative cough stress and pad tests, and subjective cure reported as satisfaction and no desire for additional treatment. Secondary outcomes: quality-of-life by IQOL and UDI-6 questionnaires, complications and reoperation rates. Student's t, (2), Fisher's exact, and Mann-Whitney tests, ANOVA and P<0.05 as cut-off point were used for statistics. ResultsA total of 82 patients (n:41 each arm) completed 36-month follow-up. Objective cure was lower in the SIMS compared to TOT groups by both per protocol (68.3% and 90.2%, respectively, P=0.027) and intention-to-treat analysis considering missing data as failures (40.6% and 60.7%, respectively, P=0.035), while similar in both groups (81.2% and 93.4%, respectively) considering missing data as successes. Subjective cure rates were similar for both groups. TOT group presented better outcome regarding the avoidance and limiting behavior domain of IQOL (P=0.021), and UDI-6 scores (P=0.026). Seven out of 69 (10.1%) women in the SIMS group compared with two out of 61 (3.3%) in the TOT group (P=0.172) had repeat surgery due to recurrent SUI at year follow up. ConclusionTOT was associated to higher objective cure rate than SIMS for SUI treatment although satisfaction rate was similar for both groups 3 years postoperative.