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.