Sacral Neuromodulation is a guideline-recommended treatment for urinary dysfunction and fecal incontinence in patients that have failed conservative treatments. Historically, SNM has been delivered using a non-rechargeable device with an average lifespan of 4. 4 years requiring surgery to replace the implanted neurostimulator (INS) due to battery depletion. Implantation of a long-lived INS can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and healthcare costs. The Axonics® r-SNM® System, is a miniaturized, rechargeable Sacral Neuromodulation (r-SNM) system designed to deliver therapy for at least 15 years. The ARTISAN-SNM study is a pivotal study using r-SNM therapy to treat urinary urgency incontinence (UUI). 6-month results are presented.
129 eligible UUI patients were treated. All participants were implanted with a tined lead and the r-SNM system 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 participant satisfaction questionnaire. Therapy responders were identified as participants with ≥50% reduction in UUI episodes compared to baseline. An as treated analysis was performed in all implanted participants.
At 6 months, 90% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2 (mean ± standard error). Participants experienced clinically meaningful improvements of 34 points on the ICIQ-OABqol questionnaire. There were no serious device-related adverse events.
The Axonics r-SNM® System is safe and effective, with 90% of participants experiencing clinically and statistically significant improvements in UUI symptoms.
The Journal of urology. 2019 Jul 26 [Epub ahead of print]
R McCrery, F Lane, K Benson, C Taylor, O Padron, B Blok, S Wachter, A Pezzella, J Gruenenfelder, M Pakzad, M A Perrouin-Verbe, L Le Normand, P Van Kerrebroeck, J Mangel, K Peters, M Kennelly, A Shapiro, U Lee, C Comiter, M Mueller, H B Goldman
Adult & Pediatric Urology & Urogynecology, Omaha, Nebraska., University of California, Irvine, California., Sanford Hospital, Sioux Falls, South Dakota., Taylor Surgical Arts, Harrison, Arkansas., Florida Urology Partners, Tampa, Florida., Erasmus MC, Rotterdam, The Netherlands., University Hospital Antwerpen, Edegem, Belgium., Southern Urogynecology, West Columbia, South Carolina., Orange County Urology Associates, Laguna Hills, California., University College London Hospital, Marylebone, London., CHU de Nantes Hotel Dieu, Nantes, France., Maastricht University Medical Centre, Maastricht, The Netherlands., MetroHealth, Cleveland, Ohio., Beaumont Health, Royal Oak, Michigan., Carolinas Healthcare System Charlotte, North Carolina., Chesapeake Urology Research Associates, Owings Mills, Maryland., Virginia Mason, Seattle, Washington., Stanford University, Palo Alto, California., Northwestern University, Chicago, Illinois., Cleveland Clinic, Cleveland, Ohio.