Rebecca McCrery1, Felicia Lane2, Kevin Benson3, Chris Taylor4, Osvaldo Padron5, Bertil Blok6, Stefan De Wachter7, Andrea Pezzella8, Jennifer Gruenenfelder9, Mahreen Pakzad10, Marie-Aimee Perrouin-Verbe11, Loïc Le Normand11, Philip Van Kerrebroeck12, Jeffrey Mangel13, Kenneth Peters14, Michael Kennelly15, Andrew Shapiro16, Una Lee17, Craig Comiter18, Margaret Mueller19, Howard B Goldman20. 1. Adult and Pediatric Urology and Urogynecology, Omaha, Nebraska. 2. University of California, Irvine, California. 3. Sanford Hospital, Sioux Falls, South Dakota. 4. Taylor Surgical Arts, Harrison, Arkansas. 5. Florida Urology Partners, Tampa, Florida. 6. Erasmus Medical Center, Rotterdam, The Netherlands. 7. University Hospital Antwerpen, Edegem, Belgium. 8. Southern Urogynecology, West Columbia, South Carolina. 9. Orange County Urology Associates, Laguna Hills, California. 10. University College London Hospital, Marylebone, London, United Kingdom. 11. Centre Hospitalier Universitaire de Nantes Hotel Dieu, Nantes, France. 12. Maastricht University Medical Centre, Maastricht, The Netherlands. 13. MetroHealth, Cleveland, Ohio. 14. Beaumont Health, Royal Oak, Michigan. 15. Carolinas Healthcare System, Charlotte, North Carolina. 16. Chesapeake Urology Research Associates, Owings Mills, Maryland. 17. Virginia Mason, Seattle, Washington. 18. Stanford University, Palo Alto, California. 19. Northwestern University, Chicago, Illinois. 20. Cleveland Clinic, Cleveland, Ohio.
Abstract
PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.
PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.
Authors: Andrea Pezzella; Rebecca McCrery; Felicia Lane; Kevin Benson; Chris Taylor; Osvaldo Padron; Bertil Blok; Stefan de Wachter; Jennifer Gruenenfelder; Mahreen Pakzad; Marie-Aimee Perrouin-Verbe; Philip van Kerrebroeck; Jeffrey Mangel; Kenneth Peters; Michael Kennelly; Andrew Shapiro; Una Lee; Craig Comiter; Margaret Mueller; Howard B Goldman Journal: Neurourol Urodyn Date: 2021-01-28 Impact factor: 2.696
Authors: Ruth Louise Poole; Megan Dale; Helen Morgan; Tosin Oladapo; Rebecca Brookfield; Rhys Morris Journal: Appl Health Econ Health Policy Date: 2021-12-29 Impact factor: 3.686
Authors: Bertil Blok; Philip Van Kerrebroeck; Stephan de Wachter; Alain Ruffion; Frank Van der Aa; Marie Aimée Perrouin-Verbe; Sohier Elneil Journal: Neurourol Urodyn Date: 2020-04-03 Impact factor: 2.696
Authors: Kevin Benson; Rebecca McCrery; Chris Taylor; Osvaldo Padron; Bertil Blok; Stefan de Wachter; Andrea Pezzella; Jennifer Gruenenfelder; Mahreen Pakzad; Marie-Aimee Perrouin-Verbe; Philip Van Kerrebroeck; Jeffrey Mangel; Kenneth Peters; Michael Kennelly; Andrew Shapiro; Una Lee; Craig Comiter; Margaret Mueller; Howard Goldman; Felicia Lane Journal: Neurourol Urodyn Date: 2020-04-27 Impact factor: 2.696
Authors: Marcelo Mass-Lindenbaum; D Calderón-Pollak; H B Goldman; Javier Pizarro-Berdichevsky Journal: Int Braz J Urol Date: 2021 May-Jun Impact factor: 1.541