AUA 2019: Long-Term Results of Safety, Efficacy, Quality of Life And Satisfaction of Patients Treated for Refractory OAB Using an Implantable Tibial Neurostimulation System: RENOVA iStim™ System

Chicago, IL (UroToday.com) Dr. Roger Dmochowski presented 3-year follow-up results on the treatment of patients suffering from refractory OAB with the RENOVA iStim™ System; an implantable tibial neurostimulation device.

A wireless peripheral neurostimulator device (BlueWind Medical Ltd.) was implanted in patients with refractory OAB, on the posterior tibial nerve, approximately 5cm above the medial malleolus. The implant electrically stimulates the tibial nerve and is wirelessly powered by a wearable external control unit (ECU) which controls the therapeutic parameters and is worn by the patient on the lower leg during specified treatment periods in home settings. A Clinician Programmer (CP) unit is used to set individual stimulation parameters for each patient to optimize therapeutic outcome.

There was 21 OAB patients, who were previously implanted with the RENOVA iStim system for a 6-month multi-center pilot study, were enrolled in a 3-year, long term, extension study. The performance and safety of RENOVA-iStim system were assessed using a voiding diary and quality of life questionnaire.

There was no SAEs were reported during the extended follow-up period. Seventy five percent (15/20) of the patients demonstrated clinical success in OAB symptoms throughout 3 years compared to baseline. This was supported by statistically significant long-term sustainable improvement in the overall Health-Related Quality of Life (HRQL) score as well as in all subscales (coping, sleeping, concern, social) and in the symptoms severity score, with 70% of the patients showing >10 points improvement (meaningful important difference) in HRQL. The majority of the patients reported being either moderately or very satisfied from the treatment throughout the 3-year follow-up.

The author concluded that BlueWind Medical RENOVA iStim System for the treatment of OAB demonstrates long-term safety and efficacy results as well as a sustainable significant improvement in the quality of life of patients.

Presented by: Roger R. Dmochowski, MD., MMHC, Professor Department of Urologic Surgery, Vice Chair for Faculty Affairs and Professionalism Section of Surgical Sciences, Associate Surgeon-in-Chief Vanderbilt University Medical Center
Co-Authors: Philip Van Kerrebroeck, Maastricht, Netherlands, Guiseppe A. Digesu, Sohier Elneil, London, United Kingdom, John P.F.A. Heesakkers, Nijmegen, Netherlands

Written by: Bilal Farhan, MD, Clinical Instructor, Female Urology and Voiding Dysfunction, Department of Urology, University of California, Irvine @BilalfarhanMD at the American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois