Bertil Blok1, Philip Van Kerrebroeck2, Stefan de Wachter3, Alain Ruffion4, Frank Van der Aa5, Ranjana Jairam2, Marie Aimée Perrouin-Verbe6, Sohier Elneil7. 1. Department of Urology, Erasmus MC, Rotterdam, The Netherlands. 2. Department of Urology, Maastricht University Medical Centre, Maastricht, The Netherlands. 3. Department of Urology, University Hospital Antwerpen, Edegem, Belgium. 4. Department of Urology, Hôpital Lyon Sud, Pierre Bénite, Lyon, France. 5. Department of Urology, UZ Leuven, Leuven, Belgium. 6. Department of Urology, University Hospital of Nantes, Nantes, France. 7. Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, United Kingdom.
Abstract
AIMS: Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. METHODS: This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). RESULTS: At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. CONCLUSIONS: The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.
AIMS: Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. METHODS: This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). RESULTS: At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. CONCLUSIONS: The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience.
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
Authors: Thomas C Dudding; Paul A Lehur; Michael Sørensen; Stefan Engelberg; Maria Paola Bertapelle; Emmanuel Chartier-Kastler; Karel Everaert; Philip Van Kerrebroeck; Charles H Knowles; Lilli Lundby; Klaus E Matzel; Arantxa Muñoz-Duyos; Mona B Rydningen; Stefan de Wachter Journal: Neuromodulation Date: 2021-07-15