Treatment starts in pivotal study of novel device for women with OAB

October 8, 2020

The OASIS trial is examining the capability of the RENOVA iStim implantable tibial neuromodulation system to reduce urinary urgency incontinence episodes.

The first US patient has been implanted in the 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 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.

The device was implanted by Becky McCrery, MD, and Emily Kean, MD, at Adult Pediatric Urology & Urogynecology in Omaha.

“Overactive bladder can be debilitating and stressful. Many patients tell me that they will limit how far or frequently they venture from home—and that the first thing they do when arriving at a restaurant or a store, is to locate the restroom. While current treatments work for some OAB sufferers, there is a need for more effective, discreet and minimally invasive treatment options for women who do not benefit from medications and don’t want more invasive surgery,” McCrery, the OASIS study principal investigator at the site, stated in a press release.

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.

“I’m pleased to say that our first implant procedure went smoothly. The RENOVA iStim implant was placed during an outpatient procedure and treatment will now be done at the patient’s home. Especially now during a pandemic, having an option that does not require frequent doctor visits, and allows women to manage their treatment at home on their schedule, may be of interest to many women with OAB. Dr McCrery and I are excited to be investigators in the OASIS clinical trial and we look forward to enrolling several women who meet the trial qualifications at our site to advance this important research,” Kean, an OASIS study co-investigator, 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. First U.S. Patient Treated in OASIS Clinical Trial of RENOVA iStim System for Overactive Bladder. Posted October 8, 2020. Accessed October 8, 2020. https://yhoo.it/36Linmg.

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