3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome

No AccessJournal of UrologyAdult Urology1 Sep 20203-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome Manon J. te Dorsthorst, Giuseppe A. Digesu, Visha Tailor, Michelle Gore, Phillip E. van Kerrebroeck, Hendrikje M. K. van Breda, Sohier Elneil, and John P. F. A. Heesakkers Manon J. te DorsthorstManon J. te Dorsthorst *Correspondence: Department of Urology, RadboudUMC, Nijmegen , the Netherlands E-mail Address: [email protected] Department of Urology, RadboudUMC, Nijmegen, the Netherlands , Giuseppe A. DigesuGiuseppe A. Digesu Imperial College NHS Healthcare, National Hospital of Neurology and Neurosurgery, London, United Kingdom , Visha TailorVisha Tailor Imperial College NHS Healthcare, National Hospital of Neurology and Neurosurgery, London, United Kingdom , Michelle GoreMichelle Gore Imperial College NHS Healthcare, National Hospital of Neurology and Neurosurgery, London, United Kingdom , Phillip E. van KerrebroeckPhillip E. van Kerrebroeck Department of Urology, Maastricht University Medical Center, Maastricht, the Netherlands , Hendrikje M. K. van BredaHendrikje M. K. van Breda Department of Urology, UMC Utrecht, Utrecht, the Netherlands , Sohier ElneilSohier Elneil Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, United Kingdom , and John P. F. A. HeesakkersJohn P. F. A. Heesakkers Department of Urology, RadboudUMC, Nijmegen, the Netherlands View All Author Informationhttps://doi.org/10.1097/JU.0000000000001024AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We evaluated the 3-year safety and efficacy of the BlueWind Medical RENOVA™ iStim system for the treatment of overactive bladder syndrome. Materials and Methods: All patients who previously underwent implantation with the RENOVA system were offered continued participation. The primary long-term study end point was to evaluate the safety profile based on incidence of serious adverse events (system and/or procedure related), which was measured by the impact and frequency of serious adverse events. The secondary end points included clinical improvement compared to baseline and quality of life improvement compared to baseline at 36 months, which was measured by 3-day voiding diary and quality of life questionnaires at certain time points. Results: Of the 34 patients with overactive bladder syndrome who previously underwent implantation with the RENOVA system 20 consented to continuation in this 3-year followup study. Mean patient age was 56.1 years and 80% (16) of the study cohort was female. The overall treatment success rate was 75% at 36 months in the per protocol (16) and the intent to treat (20) analyses. In total, 73% of the patients reported improvement in health related quality of life scores above the minimal important difference of 10 points. Conclusions: This 3-year followup study using the BlueWind RENOVA iStim system for the treatment of overactive bladder syndrome symptoms confirms the long-term good safety profile with no technical failures reported. Lasting treatment efficacy is mirrored by a sustained positive impact on patient quality of life. References 1. : An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn 2010; 29: 4. Google Scholar 2. : A novel leadless, miniature implantable tibial nerve neuromodulation system for the management of overactive bladder complaints. Neurourol Urodyn 2018; 37: 1060. Google Scholar 3. : The efficacy of posterior tibial nerve stimulation for the treatment of overactive bladder in women: a systematic review. Int Urogynecol J 2012; 23: 1591. Google Scholar 4. : Clinical utility of neurostimulation devices in the treatment of overactive bladder: current perspectives. Med Devices (Auckl) 2017; 10: 109. Google Scholar 5. : Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study. J Urol 2001; 165: 1193. Link, Google Scholar 6. : Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn 2012; 31: 1206. Google Scholar 7. : Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation. BJU Int 2006; 97: 113. Google Scholar 8. : Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. J Urol 2001; 166: 914. Link, Google Scholar 9. : Posterior tibial nerve stimulation in the treatment of urge incontinence. Neurourol Urodyn 2003; 22: 17. Google Scholar 10. : Effectiveness of percutaneous tibial nerve stimulation in the treatment of overactive bladder syndrome. Res Rep Urol 2017; 9: 145. Google Scholar 11. : Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary?BJU Int 2006; 97: 547. Google Scholar 12. : Long-term real-life adherence of percutaneous tibial nerve stimulation in over 400 patients.Neurourol Urodyn 2020; 39: 702. Google Scholar 13. : A new implanted posterior tibial nerve stimulator for the treatment of overactive bladder syndrome: 3-month results of a novel therapy at a single center. J Urol 2017; 198: 205. Link, Google Scholar 14. : Urgent-SQ implant in treatment of overactive bladder syndrome: 9-year follow-up study. Neurourol Urodyn 2013; 32: 472. Google Scholar 15. : Determining the importance of change in the overactive bladder questionnaire.J Urol 2006; 176: 627. Link, Google Scholar 16. : Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407. Crossref, Medline, Google Scholar 17. : Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6-week protocol. BJU Int 2010; 106: 1673. Google Scholar 18. : Feasibility of a fully implanted, nickel sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence. J Urol 2019; 201: 967. Link, Google Scholar 19. : A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12-month results from the RELAX-OAB study. Neurourol Urodyn 2019; 38: 689. Google Scholar 20. : New novel chronic tibial neuromodulation (CTNM) treatment option for OAB significantly improves urgency (UI)/urge urinary incontinence (UUI) and normalizes sleep patterns: initial results. Eur Urol Suppl 2017; 16: e994. Google Scholar 21. : Five-year followup results of a prospective, multicenter study of patients with overactive bladder treated with sacral neuromodulation. J Urol 2018; 199: 229. Link, Google Scholar 22. : Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol 2007; 178: 2029. Link, Google Scholar No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 204Issue 3September 2020Page: 545-550Supplementary Materials Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.Keywordselectric stimulationoveractiveprostheses and implantsurinary incontinenceimplantable neurostimulatorsurgeurinary bladderMetricsAuthor Information Manon J. te Dorsthorst Department of Urology, RadboudUMC, Nijmegen, the Netherlands *Correspondence: Department of Urology, RadboudUMC, Nijmegen , the Netherlands E-mail Address: [email protected] More articles by this author Giuseppe A. Digesu Imperial College NHS Healthcare, National Hospital of Neurology and Neurosurgery, London, United Kingdom More articles by this author Visha Tailor Imperial College NHS Healthcare, National Hospital of Neurology and Neurosurgery, London, United Kingdom More articles by this author Michelle Gore Imperial College NHS Healthcare, National Hospital of Neurology and Neurosurgery, London, United Kingdom More articles by this author Phillip E. van Kerrebroeck Department of Urology, Maastricht University Medical Center, Maastricht, the Netherlands More articles by this author Hendrikje M. K. van Breda Department of Urology, UMC Utrecht, Utrecht, the Netherlands More articles by this author Sohier Elneil Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, London, United Kingdom More articles by this author John P. F. A. Heesakkers Department of Urology, RadboudUMC, Nijmegen, the Netherlands More articles by this author Expand All No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Advertisement PDF downloadLoading ...