Runninghead: ALTIS SINGLE INCISION SLING The Safety and Efficacy of a New Adjustable Single Incision Sling for Treatment of Female Stress Urinary Incontinence Through 12-months of Follow-up

Purpose: The purpose of this report is to describe the safety and efficacy of the Altis ® Single Incision Sling System (Altis sling) for treatment of female stress urinary incontinence through 12 months. Materials and Methods: This study collected a variety of safety and efficacy measures relevant to assessment of urinary incontinence. The primary efficacy endpoint was improvement in 24hour pad weight test. Other efficacy measures included Cough Stress Test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, Patient Global Impression of Improvement, and 3-day voiding diary. Safety was evaluated through assessment of device and procedure-related adverse events. Results: Of 116 surgical attempts, 113 subjects were implanted with the Altis sling. 103 had primary efficacy data at baseline and 6 months, and 101 had efficacy data at baseline and 12 months. Consequently, 88 (85.4%) subjects at 6 months and 91 (90.1%) at 12 months achieved ≥50% reduction in pad weight. The Cough Stress Test was negative for 95 (92.2%) subjects at 6 months and 91 (90.1%) at 12 months. A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months. A majority of subjects reported feeling “much better” or “very much better” at 6 and 12 months. There were no reports of mesh erosion or migration, and no unanticipated adverse events through 12 months. Conclusions: The Altis sling appears to be safe, efficacious, and performs as intended in the treatment of stress urinary incontinence through 12 months. Runninghead: ALTIS SINGLE INCISION SLING