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A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress
Ty Erickson1, Jan-Paul Roovers2, Edward Gheiler3
1Department of Gynaecology, Rosemark Women Care Specialists, Idaho Falls, Idaho (Dr. Erickson).
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.
