Pivotal trial of neuromodulation device for urge urinary incontinence completes enrollment

The pivotal OASIS trial of the RENOVA iStim tibial neuromodulation system for the treatment of women with urge urinary incontinence (UUI) has completed enrollment, according to BlueWind Medical, the developer of the device.1

The study enrolled its target goal of 150 patients at 23 clinical sites in the United States, United Kingdom, The Netherlands, and Belgium. The patients have now been screened and implanted.

RENOVA is a wireless peripheral neurostimulator device that a clinician implants in the patient’s ankle with the patient under local anesthesia. The device electrically stimulates the tibial nerve. It is powered by a wearable cuff, which the patient wears for 30 to 60 minutes a day.

"What sets the RENOVA iStim apart from other available devices is our patient-centric approach to managing the symptoms of urgency incontinence," Roger R. Dmochowski, MD, chief medical officer, BlueWind Medical, stated in a news release. "RENOVA can be adjusted to meet the individual needs of the patient, meaning that a patient can change stimulation parameters, or wear the control unit for as much or as little as the patient feels they need to improve their symptoms."

The multicenter, open-label, prospective, interventional OASIS trial (NCT03596671) is a single-group assignment trial that will administer RENOVA to all enrolled patients.2 Eligible patients are females aged ≥18 in Europe and ≥21 in the United States who have at least a 6-month history of UUI diagnosis. Patients were not eligible if they were breastfeeding, had predominant stress incontinence, or had been diagnosed with interstitial cystitis or bladder pain syndrome per the criteria in the AUA or EAU guidelines.

The primary efficacy end point of improving UUI episodes will be evaluated based on patients’ voiding diaries completed through 6 months of treatment. The estimated primary completion date of the study is June 2022. BlueWind plans to submit the OASIS data to the FDA next year to seek marketing clearance for RENOVA.

Pilot study showed promise of RENOVA

The decision to launch the OASIS study was supported by the initial pilot study of RENOVA. Three-year follow-up data from the pilot study were recently published in the Journal of Urology.3

The pilot study initially included 34 patients with OAB who were followed for 6 months. Of these patients, 20 patients consented to continuation for the 3-year follow-up analysis. The average patient age was 56.1 years and 16 (80%) of the 20 patients were female.

At 36 months, the treatment success rate was 75%. Significant improvement was also reported in health-related quality of life scores. In their conclusion, the authors wrote that RENOVA’s “Lasting treatment efficacy is mirrored by a sustained positive impact on patient quality of life.”

References

1. Bluewind Medical™ Ltd. Completes OASIS Study Patient Enrollment. Published online November 16, 2021. Accessed November 18, 2021. https://prn.to/3HL3zEz

2. NIH US National Library of Medicine: ClinicalTrials.gov. BlueWind RENOVA iStim™ System for the Treatment of OAB (OASIS). Updated November 16, 2021. Accessed November 18, 2021. https://bit.ly/33VXsM9.

3. Te Dorsthorst MJ, Digesu GA, Tailor V, et al. 3-year follow-up of a new implantable tibial nerve stimulator for the treatment of overactive bladder syndrome. J Urol. 2020;204(3):545-550. doi: 10.1097/JU.0000000000001024