A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence

Study objective: The aim of the Altis 522 study was to compare the safety and efficacy of the Altis Single-Incision Sling System (SIS) (Coloplast, Minneapolis, MN) with standard midurethral transobturator and/or retropubic slings through 36 months. In this report, we present data through 12 months of follow-up.

Design: Postmarket, prospective, multicenter, nonrandomized cohort design.

Setting: The study was performed at 23 hospitals in the United States and Canada.

Patients: Adult female patients with stress urinary incontinence (SUI) clinically indicated for an incontinence sling were treated (n = 355).

Interventions: Altis SIS was compared with any Food and Drug Administration-cleared transobturator or retropubic sling.

Measurements and main results: Collected measures included device- and/or procedure-related serious adverse events, relevant nonserious and all adverse events, and revision surgery. Objective efficacy measures included 24-hour pad weight, dryness (defined as pad weight ≤4.0 g), and cough stress test. Subjective outcome measures included patient global impression of improvement, urogenital distress inventory, Incontinence Impact Questionnaire-Short Form, Surgical Satisfaction Questionnaire, and visual analog scale for pain. At 12 months, 24-hour pad weight success (≥50% reduction), negative cough stress test, patient global impression of improvement, urogenital distress inventory, and Incontinence Impact Questionnaire-Short Form appeared similar between groups. Through 12 months, 2 subjects in the Altis group and 3 subjects in the comparator group experienced a serious device- and/or procedure-related adverse event. In the Altis group, 1 subject (0.5%) experienced a device revision, and 1 subject (0.5%) had the device explanted. In the comparator group, 7 subjects (4.1%) experienced a device revision, and 1 device (0.6%) was explanted before the 12-month visit. The occurrence of relevant nonserious procedure and/or device-related adverse events was similar between groups.

Conclusion: At 12-months follow-up, safety and efficacy appeared similar between Altis SIS and standard transobturator and retropubic midurethral slings.