Pivotal study launches exploring novel device for women with OAB

August 11, 2020

The OASIS study is examining the RENOVA iStim implantable tibial neuromodulation system for the treatment of women with overactive bladder.

The OverActive Bladder Stimulation System Study (OASIS) has launched, aiming to establish the safety and efficacy of the RENOVA iStim implantable tibial neuromodulation system for the treatment of women with overactive bladder (OAB).1,2

The multicenter, open-label, prospective, interventional OASIS trial (NCT03596671) is specifically examining the capability of RENOVA to reduce urinary urgency incontinence (UUI) episodes. The study, which has an enrollment goal of 200 patients, is recruiting patients at 15 sites in the United States and Europe.

“Only a small percentage of patients with overactive bladder are treated with current devices due to the complexity, invasiveness, complications, cost and need for reintervention of current therapies. The RENOVA System has the potential to address the unmet need for a minimally invasive, home-based treatment option. Especially now, COVID-19 has exposed the benefits of wearables and treatments that do not require multiple visits to the physician’s office," Roger R. Dmochowski, MD, professor, Department of Urologic Surgery, associate surgeon-in-chief, Vanderbilt University Medical Center, 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.

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. 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.

2. 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.

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