Presentation Authors: Roger R. Dmochowski*, Nashville, TN, Philip Van Kerrebroeck, Maastricht, Netherlands, Guiseppe A. Digesu, Sohier Elneil, London, United Kingdom, John P.F.A. Heesakkers, Nijmegen, Netherlands
Introduction: Neuromodulation is an accepted third line therapy for the treatment of refractory overactive bladder (OAB). The only commercially available neuromodulation systems options include implantable sacral nerve modulation (SNM) and percutaneous tibial nerve stimulation (PTNS), and only scarce data exist on implantable tibial nerve stimulation systems and none with long-term results. We hereby present 3-year follow-up results on the treatment of patients suffering from refractory OAB with the RENOVA iStimâ„¢ System; an implantable tibial neurostimulation device.
Methods: 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. Twenty OAB patients, who were previously implanted with the RENOVA iStimâ„¢ 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-iStimâ„¢ system were assessed using a voiding diary and quality of life questionnaire.
Results: No SAEs were reported during the extended follow-up period. Seventy five percent (15/20) of the patients demonstrated clinical success in OAB symptoms (â‰¥50% reduction in urgent voids or leaks or normalization of voids) 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 (scale of â€œ1; very satisfiedâ€ to â€œ4; not satisfiedâ€).
Conclusions: The BlueWind Medical RENOVA iStim System for the treatment of OAB demonstrates long-term safety and efficacy results as well as sustainable significant improvement in the quality of life of patients.
Source of Funding: BlueWind Medical Ltd.