Pivotal OAB trial of novel implantable neuromodulation system hits enrollment milestone

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The 100th patient has been enrolled in the pivotal OASIS trial of the RENOVA iStim tibial neuromodulation system for the treatment of women with overactive bladder (OAB), according to BlueWind Medical, the developer of the device.¹

The patient was enrolled and implanted with the device by Alex Digesu, MD, PhD, consultant obstetrician and gynecologist at St. Mary's Hospital in London. "I had the privilege of taking part both to the pilot and pivotal trials of the RENOVA iStim System," Digesu stated in a press release. "I find the RENOVA iStim a device easy to implant for a surgeon and easy to operate for a patient."

The multicenter, open-label, prospective, interventional OASIS trial (NCT03596671) is specifically examining the capability of RENOVA to reduce urinary urgency incontinence (UUI) episodes.^2,3 The study, which has an enrollment goal of 200 patients, is recruiting patients at 20 to 25 sites in the United States and Europe.

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.

As a single-group assignment trial, OASIS will administer RENOVA to all enrolled patients. Participating countries include the United States, Belgium, and the Netherlands. 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 are not eligible if they are breastfeeding, have predominant stress incontinence, or have 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 February 2021.

"Several advantages (battery-less, leadless, miniature, closed loop stimulation) make RENOVA iStim innovative neuromodulation system an interesting option for patients with overactive bladder symptoms who do not respond to, or cannot tolerate, conventional medical therapy," Digesu stated in the press release.

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.⁴

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 Reaches 100th Patient for the OASIS Study of the RENOVA™ iStim System. Posted June 6, 2021. Accessed June 7, 2021. https://prn.to/36kenI8.

2. NIH US National Library of Medicine: ClinicalTrials.gov. BlueWind RENOVA iStim™ System for the Treatment of OAB (OASIS). Posted July 24, 2018. https://bit.ly/33VXsM9. Accessed August 11, 2020.

3. BlueWind Initiates U.S. Enrollment in Clinical Trial of the RENOVA iStim to Treat Overactive Bladder. Published August 11, 2020. https://bit.ly/33PDToz. Accessed August 11, 2020.

4. 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