New implantable tibial nerve stimulator delivers long-term safety in overactive bladder syndrome
Use of the novel implantable tibial nerve stimulator, named BlueWind RENOVA iStim system, for the treatment of overactive bladder syndrome symptoms offers long-term safety with no reported technical failures, according to a recent study with a 3-year follow-up. The sustained positive impact on patient quality of life reflects the long-term efficacy of the device.
All patients who previously underwent implantation with the RENOVA system were offered continued participation in this study to assess the safety profile of the device based on incidence of serious adverse event (system- or procedure-related), which was measured by its impact and frequency. Other endpoints included clinical and quality of life improvements from baseline at 36 months, which was measured by 3-day voiding diary and quality-of-life questionnaires at certain time points.
Thirty-four patients with overactive bladder syndrome previously underwent implantation with the novel tibial nerve stimulator, of whom 20 consented to continue in this 3-year follow-up study. These participants had a mean age of 56.1 years, and majority of the cohort were female (80 percent).
At 36 months, the overall treatment success rate stood at 75 percent in the per-protocol and the intent-to-treat analyses. Of the patients who continued the study, 73 percent reported improvement in health-related quality of life scores above the minimal important difference of 10 points.
“This 3-year follow-up study using the BlueWind RENOVA iStim system for the treatment of overactive bladder syndrome symptoms confirms the long-term good safety profile [of the device],” the investigators said.