Revi implantable tibial neuromodulation shows durable 3-year response rates in UUI

Three-year follow-up data from the pivotal OASIS study (NCT03596671) suggest that implantable tibial neuromodulation using the Revi system may provide sustained symptom improvement and favorable safety outcomes in women with urgency urinary incontinence (UUI).

The findings were reported in 2 poster presentations at the 2026 Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), one focusing on long-term efficacy and safety outcomes and the other on patient-reported quality-of-life measures.^1,2 The results extend earlier findings from the OASIS trial that supported US regulatory clearance of the device.

Overall, investigators reported that 79% of evaluable participants achieved at least a 50% reduction in UUI episodes at 3 years, with more than half reporting reductions of 75% or greater. No device- or procedure-related serious adverse events were reported during long-term follow-up.

Study design

OASIS is a prospective, multicenter, single-arm clinical trial evaluating the safety and efficacy of the Revi system for the treatment of UUI symptoms associated with overactive bladder (OAB). A total of 151 adult women underwent implantation of the device. The mean age of participants was 58.8 years.

Primary efficacy and safety end points were previously assessed at 6 and 12 months, respectively. Participants who completed the 12-month study were eligible to enroll in an extended follow-up phase. Among the 140 patients who completed the first year of follow-up, 119 (85%) patients consented to participate in the 36-month extension, and 90 patients ultimately completed the 3-year assessment.

Efficacy and safety

The first poster detailed long-term safety and efficacy findings from the OASIS trial. Therapeutic response was defined as a reduction of at least 50% in UUI episodes recorded in a 3-day voiding diary. At 36 months, 79% (71 of 90) of evaluable participants met this response threshold. The response rate remained consistent with earlier time points, with a reported responder rates of 78% at 6 months. More than half of participants experienced reductions in UUI episodes of at least 75% through 36 months.

Additional symptom measures suggested sustained improvements in other bladder-related outcomes. Nocturia frequency decreased from a baseline average of 1.3 episodes per night to 0.9 at 36 months.

Investigators reported no device- or procedure-related serious adverse events during the 36-month follow-up period. Five participants underwent device explantation during the study. Importantly, there were no reported cases of device migration, and no revision procedures were required.

Quality of life

The second poster focused on quality-of-life results from the study. Patients completed quality of life questionnaires at annual follow-up visits.

At the 3-year follow-up visit, 95% of respondents reported satisfaction with therapy on the Benefit, Satisfaction, and Willingness to Continue questionnaire. Nearly all respondents (98%) indicated willingness to continue treatment, and 96.7% reported feeling “better” or “very much better” on the Patient Global Impression of Improvement scale.

“With the most comprehensive and longest-term data in Implantable Tibial Neuromodulation, BlueWind has set a new benchmark for durable, patient-centered therapy for UUI,” concluded presenting author Roger R. Dmochowski, MD, MMHC, FACS, Chief Medical Officer of BlueWind Medical and an associate surgeon in chief for Vanderbilt University Medical Center, Nashville, Tennessee, in a news release on the results.³ “Revi delivers consistent, long-lasting outcomes, proving that effective, minimally invasive treatment can be both simple and transformative. These results reinforce Revi’s position as the gold standard for clinical evidence, patient satisfaction, and sustained quality-of-life improvement in urgency urinary incontinence.”

REFERENCES

1. Amundsen C, Sutherland SE, Heesakkers J, et al. Three-year outcomes of Revi Implantable Tibial Neuromodulation – Safety and efficacy results from the extended OASIS study. Presented at: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting. February 25-28, 2026. San Juan, Puerto Rico. Abstract OM07

2. Amundsen C, Sutherland SE, Heesakkers J, et al. Three-year outcomes of Revi Implantable Tibial Neuromodulation – Quality of life results from the extended OASIS study. Presented at: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting. February 25-28, 2026. San Juan, Puerto Rico. Abstract MP27

3. Three-Year Data Reinforce Revi® System as the Most Clinically Validated Implantable Tibial Neuromodulation Therapy for Urgency Urinary Incontinence. News release. BlueWind Medical, Ltd. February 27, 2026. Accessed March 11, 2026. https://www.businesswire.com/news/home/20260227984763/en/Three-Year-Data-Reinforce-Revi-System-as-the-Most-Clinically-Validated-Implantable-Tibial-Neuromodulation-Therapy-for-Urgency-Urinary-Incontinence