Two-year outcomes for the Altis® adjustable single incision sling system for treatment of stress urinary incontinence

AimsEvaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months. MethodsThis was a prospective, multi-center, industry-sponsored (Coloplast Corp.), single-arm trial with primary efficacy defined as 50% reduction in 24h 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. ResultsOf the 113 women implanted, 94 remained at 24-months. The average procedure time was 12.88.4min 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 4.0g), 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. ConclusionsThe 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.