Plenary: Next Frontier, Sunday, Afternoon Session
Presentation Authors: Howard Goldman*, Cleveland, OH, Felicia Lane, Orange, CA, Rebecca McCrery, Omaha, NE, Kevin Benson, Sioux Falls, SD, Chris Taylor, Harrison, AR, Osvaldo Padron, Tampa, FL, Stefan De Wachter, Edegem, Belgium, Bertil Blok, Rotterdam, Netherlands, Andrea Pezzella, West Columbia, SC
Introduction: Sacral Neuromodulation (SNM) is a guideline-recommended treatment for urinary and bowel dysfunction in patients that have failed conservative therapy. Historically, SNM has been delivered using a non-rechargeable device with a lifespan of 3 - 5 years, requiring surgery to replace the implanted neurostimulator due to battery depletion. Replacement surgery increases patient risks and health-care costs, which could be reduced by use of a long lived, rechargeable system. The Axonics r-SNM System, approved in Europe, Canada and Australia, is a miniaturized, rechargeable system designed to deliver therapy for at least 15 years. The ARTISAN-SNM study is a prospective, multi-center pivotal study conducted under an investigational device exemption from the US FDA with the purpose of gaining US marketing approval of the novel Axonics r-SNM System.
Methods: 129 subjects with urinary urgency incontinence across 19 centers in the US and Western Europe were treated with the Axonics r-SNM System. All subjects were implanted with a tined lead and a neurostimulator in a non-staged procedure. Efficacy data was collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a subject satisfaction questionnaire. Therapy responders at follow-up were identified as patients with a 50% reduction in urgency leaks compared to baseline. An as-treated analysis was performed in all implanted subjects.
Results: At 6 months, 90% of all implanted subjects were therapy responders (Fig A), of which 80% subjects had a greater than 75% reduction in urge leaks (34% were dry). Across all subjects, urge leaks per day reduced from 5.6 (0.3, standard error) at baseline to 1.3 (0.2) at 6 months (p<0.0001; Fig B). Subjects averaged 34 points improvement on the composite ICIQ-OABqol score as compared to baseline, which is statistically and clinically significant. Additionally, 95% of subjects were satisfied with their r-SNM therapy. One subject was explanted due to infection and one lead revision occurred due to migration. No serious device-related adverse events have been reported.
Conclusions: At 6 months, patients implanted with the Axonics r-SNM System received clinically and statistically significant improvements in UUI symptoms and quality of life.
Source of Funding: Axonics Note: The terms Axonics and r-SNM are trade-marked