Miniarc® single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes

Abstract

We report 2-year data on the effectiveness and safety of the MiniArc single-incision sling in women with stress urinary incontinence. This multi-center, prospective, single-arm, industry-sponsored study measured the effectiveness of the MiniArc sling via quantitative (cough stress test and 1-h pad weight test) and qualitative (Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form) measurements. The objective efficacy rate was defined as the number of patients with a negative cough stress test or 1-h pad weight test ≤ 1 g at 2 years. The subjective efficacy rate was determined by patient responses to the UDI-6 question # 3, "Do you experience, and if so, how much are you bothered by urine leakage related to physical activity, coughing, or sneezing?" Secondary objectives were to evaluate procedural variables of implantation and long-term safety. One hundred and eighty women with a mean age of 51.1 years were implanted in the study. Mean procedure time, blood loss, and length of stay were 11.0 min, 41.7 mL and 9.5 h respectively. At 2 years, 142 patients were available for analysis. The objective efficacy rates for the cough stress test (CST) and pad weight test (PWT) were 84.5 % and 80.1 % respectively and the subjective efficacy rate was 92.9 %. Median Urogenital Distress Inventory-Short Form and Incontinence Impact Questionnaire-Short Form scores showed statistically significant improvement (p < .001). The most common adverse events included UTI (4.8 %), constipation (3.7 %), and temporary urinary retention (3.2 %). MiniArc is a safe and effective surgical procedure for the treatment of SUI in women with follow-up through 2 years.