Published OASIS data show durable efficacy of Revi System for UUI

Data from the pivotal OASIS trial (NCT03596671) have been published in the Journal of Urology, showing that Revi System, an implantable tibial neuromodulation system for patients with urgency urinary incontinence (UUI), had sustained efficacy at 2 years.¹

The Revi System was granted FDA clearance in August 2023.

The data were initially presented at Pelvic Floor Disorders Week 2024 in Washington DC.²

“What sets Revi apart is its patient centricity. The system allows patients to tailor treatment intervals to their symptoms and providers to individualize treatment plans to each patient,” said lead author John Heesakkers, MD, chairman of the department of urology of the Maastricht University Medical Center in the Netherlands, in a news release on the data.³ “It is encouraging to see that the OASIS study long-term data continues to validate the Revi System as a durable and effective treatment for UUI.”

Overall, the study initially enrolled 151 female patients, of whom 97 completed the 24-month assessment. Of these, 79% experienced a response to therapy, and 56% achieved at least a 75% reduction in UUI episodes. The therapeutic response rate was 79% at 24 months, which was comparable to the rates seen at 6 months (78%) and 12 months (82%).

Further, at 24 months, the investigators observed significant decreases in the average number of UUI episodes and urgency-related leaks. Specifically, the average number of urgency-related leaks was 4.5 per day at baseline, which decreased to 1.3 per day at 24-month follow-up.

There was also an improvement observed in the average number of voids per day, with a reduction from 10 voids/day at baseline to 8.3 voids/day at 24-month follow-up. Additionally, 28% of patients achieved freedom from leaks for 3 consecutive days on a voiding diary.

The authors noted, “Participants who completed both the 6- (n=144) and 24-month (n=97) assessment had similar demographics and treatment results at the 6-month visit, indicating that these results at 24 months are representative of the overall study population.”

Patient-reported data showed that 97% of patients felt satisfied with the therapy, and 80% felt “much better” or "very much better” at 2-year follow-up, per the Patient Global Impression of Improvement questionnaire. All patients indicated that they were willing to continue treatment, per the Benefit Satisfaction and Willingness to Continue questionnaire.

No serious device- or procedure-related adverse events (AEs) were observed at 24-month follow-up. In total, 117 patients reported an AE, of whom 116 of patients’ AE was not related to the device or procedure. There was 1 delayed surgical site-related AE attributed to an “exuded non-absorbable, braided suture, resulting in a superficial skin infection,” which did not require explantation of the device.

In total, the prospective, multicenter, single-arm, open-label OASIS trial enrolled and implanted 151 female patients with UUI across clinical trial sites in the United States and Europe.⁴ Of those, 144, 140, and 97 patients completed the 6-, 12-, and 24-month visits, respectively. At baseline, patients demonstrated an average of 4.8 UUI episodes per day (SD, 3.0) and 10.1 voids per day (SD, 3.3). The average age of participants was 59 years (SD, 12.5).

Patients were eligible for enrollment if they experienced at least 9 UUI episodes on a 7-day diary. For the study, participants stimmed for approximately 30 minutes twice daily.

The primary efficacy end point was the proportion of responders to therapy, defined as at least a 50% improvement in the average number of UUI episodes at 6 months post-activation. The primary safety end point was the incidence of adverse events from implantation at 12 months following activation of the device.

Previous data from OASIS

In August 2023, the FDA granted a de novo marketing authorization to the Revi System based on initial 6- and 12-month data from the OASIS trial.⁵

These findings, which were published in Neurourology and Urodynamics,⁴ showed that the study met its primary end point with 76.4% of patients in the intent-to-treat population demonstrating at least a 50% reduction in UUI episodes at 6 months, which reached statistical significance in comparison with the predefined performance goal (P < .0001). At 12-month follow-up, the clinical response rate was 78.4%.

In patients who completed 12-month diaries (n = 139), 82% achieved at least a 50% reduction in UUI episodes and 66.9% achieving at least a 75% reduction. Further, 37.8% and 50% of patients classified as dry on at least 3 consecutive diaries at 6- and 12-month follow-up, respectively.

Regarding safety, no procedure- or device-related serious adverse events (AEs) were reported, and no patients required surgical reintervention or revisions due to implant migration, lead breakage, or battery replacement. In total, 15 serious AEs and 285 AEs were reported.

References

1. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. Two-year efficacy and safety outcomes of the pivotal OASIS study using the Revi System for treatment of urgency urinary incontinence. J Urol. 2024:101097JU0000000000004328. doi:10.1097/JU.0000000000004328

2. Amundsen C, Heesakkers J, Toozs-Hobson P, et al. 2 year results: Revi therapy, implanted neuromodulator for urgency incontinence. Presented at: Pelvic Floor Disorders Week 2024. October 22-25, 2024. Washington, DC

3. BlueWind Medical announces peer-reviewed data showing excellent durability of results for Revi System at two years. News release. BlueWind Medical Ltd. Published online and accessed February 7, 2025. https://www.businesswire.com/news/home/20250207113202/en/BlueWind-Medical-Announces-Peer-Reviewed-Data-Showing-Excellent-Durability-of-Results-for-Revi%C2%AE-System-at-Two-Years

4. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence. Neurourol Urodyn. 2024.doi:10.1002/nau.25477

5. BlueWind Medical's Revi System secures U.S. FDA De Novo Classification grant for the treatment of urgency incontinence. News release. BlueWind Medical. August 17, 2023. Accessed February 7, 2025. https://www.prnewswire.com/news-releases/bluewind-medicals-revi-system-secures-us-fda-de-novo-classification-grant-for-the-treatment-of-urgency-incontinence-301903199.html?tc=eml_cleartime