OASIS: Efficacy of Revi System for urgency incontinence maintained at 2 years

Two-year data from the pivotal OASIS trial (NCT03596671) demonstrate sustained efficacy of the Revi System, an implantable tibial neuromodulation system for patients with urgency urinary incontinence (UUI).¹

Cindy L. Amundsen, MD

The findings were presented by Cindy L. Amundsen, MD, at Pelvic Floor Disorders Week 2024.

"These data show that the therapeutic benefits of the Revi System are not only sustained over time but also result in consistently high patient satisfaction and a favorable safety profile, representing a meaningful technological advancement in the treatment of urgency urinary incontinence,” said Amundsen, a urogynecologist at Duke University in Durham, North Carolina, in a news release on the findings.²

Of the 151 patients initially enrolled in the trial, 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%, which is comparable to the rates seen at 6 months (78%) and 12 months (82%).

Additionally, 97% of patients indicated that they were satisfied with the therapy, and 80% indicated that they felt “much better” or "very much better” at 2-year follow-up, per the Patient Global Impression of Improvement questionnaire.

Regarding safety, no serious device- or procedure-related adverse events were observed at 24 months. There was 1 delayed surgical site-related adverse event attributed to an “exuded non-absorbable, braided suture, resulting in a superficial infection,” which did not require explantation of the device.

The authors noted, “Subjects that completed both the 6-month assessment (n=144) and the 24-month assessment (n=97) had similar demographics and results at the 6-month visit, indicating that results at 24-months are representative of the overall study population.”¹

"These findings reinforce the durability of significant response and high patient satisfaction of the Revi system, highlighting its status as the leading solution for implantable tibial neuromodulation,” said Roger Dmochowski, MD, MMHC, FACS, chief medical officer of BlueWind Medical, in the news release.² “As physicians increasingly become aware of Revi as an important UUI treatment option, we are excited to share these results with the global community of healthcare professionals dedicated to advancing care for incontinence."

Additional info on OASIS

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.³ 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, 2.9) and 10 voids per day (SD, 3.3). The average age of participants was 58.8 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. The primary safety end point was the incidence of adverse events from implantation at 12 months following activation of the device. Secondary end points included the proportion of responders, defined as at least a 50% improvement in UUI episodes or severe UUI episodes at 12 months, and the severity of leaks.

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.⁴

These findings, which were published in Neurourology and Urodynamics,³ 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, 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. Additionally, 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. 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

2. Two-year Revi therapy data reinforce sustained efficacy and safety of implantable tibial neuromodulation in managing urgency urinary incontinence. BlueWind Medical, Ltd. October 24, 2024. Accessed October 25, 2024. https://www.businesswire.com/news/home/20241024044110/en/Two-Year-Revi%C2%AE-Therapy-Data-Reinforce-Sustained-Efficacy-and-Safety-of-Implantable-Tibial-NeuroModulation-in-Managing-Urgency-Urinary-Incontinence

3. 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

4. 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 October 25, 2024. 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