Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results.Am J Obstet Gynecol. 2015 Jul; 213(1):35.e1-35.e9.AJ
The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc (American Medical Systems, Minnetonka, MN) midurethral sling (MUS) in women with stress incontinence at 12 months.
A total of 225 women were randomized to receive MiniArc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, or untreated detrusor overactivity were excluded. Objective cure was defined as negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire. Validated questionnaires, together with urodynamic and clinical cough stress test, were used to evaluate the objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (eg, Fisher exact test for dichotomous data) for categorical data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate.
There was no statistically significant difference in the subjective (92.2% vs 94.2%; P = .78; difference, 2.0%; 95% confidence interval, -2.7% to +6.7%) or objective (94.4% vs 96.7%; P = .50; difference, 2.3%; 95% confidence interval, -1.5% to +6.1%) cure rates between MiniArc and Monarc at 12 m, respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms.
MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months' follow-up in women without intrinsic sphincter deficiency.