The aim of the Altis 522 study is to compare the safety and efficacy of the Altis® Single Incision Sling (SIS) to standard mid-urethral transobturator and/or retropubic slings through 36 months. In this report we present data through 12 months of follow-up.
Post-market, prospective, multi-center, non-randomized cohort design.
The study is performed at 23 hospitals in the United States and Canada.
Adult female patients with stress urinary incontinence (SUI) clinically indicated for an incontinence sling were treated (n=355).
Altis SIS is compared to any FDA cleared transobturator or retropubic sling.
Collected measures include device- and/or procedure-related serious adverse events, relevant non-serious and all adverse events; as well as, revision surgery. Objective efficacy measures include 24-hour pad weight, dryness (defined as pad weight ≤ 4.0 grams) and cough stress test (CST). Subjective outcome measures include: Patient Global Impression of Improvement (PGI-I), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), Surgical Satisfaction Questionnaire (SSQ-8), Visual Analog Scale for Pain (VAS Pain).
At 12-months, 24-hour pad weight success (≥50% reduction), negative CST, PGI-I, UDI-6, and IIQ-7 appear similar between groups. Through 12-months, two 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, one subject (0.5%) experienced a device revision and one subject (0.5%) had the device explanted. In the Comparator group, seven subjects (4.1%) experienced a device revision and one device (0.6%) was explanted prior to the 12-month visit. The occurrence of relevant non-serious procedure and/or device related adverse events is similar between groups.
At 12 months follow-up safety and efficacy appear similar between Altis SIS and standard transobturator and retropubic midurethral slings.
Journal of minimally invasive gynecology. 2020 Apr 19 [Epub ahead of print]
Ty Erickson, Jan-Paul Roovers, Edward Gheiler, Mitesh Parekh, M Mehdi Parva, Craig Hanson, Rebecca McCrery, Le Mai Tu
Rosemark Women Care Specialists, Idaho Falls, ID., Amsterdam UMC, location AMC, Amsterdam, the Netherlands. Electronic address: ., Nova southeastern University, Urological Research Network LLC, Hialeah, FL., Genesis Healthcare, Zanesville, OH., The Group for Women/Tidewater Clinical Research, Norfolk, VA., Women's Health Advantage, Fort Wayne, IN., Adult and Pediatric Urology and Urogynecology, Omaha, NE., Department of Surgery, Division of Urology, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC.