Evaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months.
This was a prospective, multi-center, industry-sponsored (Coloplast Corp.), single-arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6-months. Device- and procedure-related complications were collected for safety. Secondary measures included cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, and Patient Global Impression of Improvement.
Of the 113 women implanted, 94 remained at 24-months. The average procedure time was 12.8 ± 8.4 min across all settings. Of those with paired baseline and follow-up data at 24-months, 90.0% (81/90) achieved ≥50% reduction in pad weight, 81.1% (73/90) were dry (pad weight ≤4.0 g), and 87.9% (80/91) had a negative cough stress test. Significant median reductions of 44.4 in Urogenital Distress Inventory (P-value <0.0001) and 52.0 in Incontinence Impact Questionnaire scores (P-value <0.0001) were observed. Additionally, 90.4% (85/94) of subjects reported "very much better" or "much better" on the Patient Global Impression of Improvement. No new device- or procedure-related adverse events occurred between the 12 and 24 month visits.
The Altis single-incision sling is a durable and effective treatment with a favorable safety profile for surgical treatment of women with stress or stress-predominant mixed urinary incontinence.
Neurourology and urodynamics. 2016 Oct 29 [Epub ahead of print]
Ervin Kocjancic, Ty Erickson, Le-Mai Tu, Edward Gheiler, Douglas Van Drie
Department of Urology, University of Illinois at Chicago, Chicago, Illinois. ., Rosemark Women Care Specialists, Idaho Falls, Idaho., Division of Urology, CHUS-Hôpital Fleurimont, Sherbrooke, Qubec., Urology Specialists, LLC, Hialeah, Florida., Female Pelvic Medicine and Urogynecology Institute of Michigan, Grand Rapids, Michigan.