3-Year Follow-Up, of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome (OAB).

PURPOSE: The objective of this study was to evaluate the 3-year safety and efficacy of the BlueWind Medical RENOVA iStim system for the treatment of OAB. MATERIALS AND METHODS: All patients who were previously implanted with the RENOVA system were offered continued participation. The primary long term study endpoint was to evaluate the safety profile based on incidence of serious adverse events (system and/or procedure related). This was measured by the impact and frequency of serious adverse event (SAE). The secondary endpoints included clinical improvement compared to baseline and quality of life improvement compared to baseline at 36 months. This was measured by 3-day voiding diary and quality of life questionnaires at certain timepoints. RESULTS: Twenty of the thirty-four OAB patients who were previously implanted with the RENOVA system have consented to continuation to this 3-year follow-up study. The mean age was 56.1 years and 80% (N=16) of the study cohort was female. The overall treatment success rate was 75% at 36 months in both the per-protocol (n=16) and the ITT analyses (n=20). In total, 73% of the patients reported improvement in HRQL scores above the minimal important difference of 10 points. CONCLUSION: This 3-year follow-up study using the BlueWind RENOVA iStim system for the treatment of OAB symptoms confirms the long term good safety profile with no technical failures reported. There is lasting efficacy of the treatment mirrored by a sustained positive impact on patients' quality of life.