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AUA 2025

Revi® System Demonstrates Significant and Sustained Quality of Life Benefits Across All Domains for the Majority of Patients with Urgency Urinary Incontinence at 24 Months

New Data Presented at the American Urological Association Annual Meeting Underscores Major Improvement in Quality of Life and Excellent Patient Satisfaction of Innovative Tibial Neuromodulation Treatment

Reno, Nevada (UroToday.com) -- BlueWind Medical, Ltd., a leader in implantable Tibial NeuroModulation (iTNM) and developer of the Revi® System, a patient-centric tibial neuromodulation solution for urgency urinary incontinence (UUI), announced today 24-month Quality of Life (QoL) results from the OASIS pivotal study showing sustained and clinically meaningful improvements [The research was presented at the annual meeting of the American Urological Association (AUA) in Las Vegas.

UUI is commonly associated with decreased quality of life, an important metric that supports comprehensive quality of clinical care for patients.1 The OASIS trial showed that Revi demonstrated consistent QoL benefits throughout 24 months, with clinically significant (≥10-point change) and sustainable improvements in symptom severity in all domains of the Overactive Bladder Questionnaire (OAB-q), including coping, concern, sleep and social, and atotal transformed Health-Related QoL (HRQL) score of (87.2%). Symptom severity (transformed score) saw a highly impactful improvement with a nearly 40-point reduction, from 70.3 to 32.4, 30.6, and 31.5 at six months, 12 months, and 24 months, respectively.

Additional study highlights:

  • As previously reported, primary efficacy and safety endpoints were met with a UUI response rate of 79.4% (≥50% decrease in UUI) and no device- or procedure-related serious adverse events.
  • At 24 months, 96.8% reported treatment benefit, 96.7% reported satisfaction, and 100% reported a willingness to continue therapy.
  • Importantly, even in participants who did not meet the efficacy endpoint at 24 months (21%), appreciable therapeutic benefit was still noted; in patients with large leaks within this subgroup, 58.8% reported no large leaks in their 24-month voiding diaries. Additionally, 83.3% reported treatment benefit, 66.7% reported satisfaction, and 100.0% reported a willingness to continue Revi therapy.
The OASIS study demonstrates that iTNM with Revi represents a highly effective treatment modality for UUI that results in clinically meaningful and sustainable improvements in both bladder-related and overall health-related QoL. These important QoL improvements were seen within six months of implant activation and were sustained through 24 months.

“OASIS findings presented today continue to underscore the strength of Revi's efficacy alongside improvements in quality of life for people living with disruptive UUI,” said Roger Dmochowski, M.D., Chief Medical Advisor, BlueWind Medical, who presented the research findings. “UUI can derail active and full lives and is often associated with significant distress. The data presented today builds on an extensive body of evidence supporting Revi as an intervention that restores quality of life for many patients.”
Source: BlueWind Medical, Ltd. (2025). Revi® System Demonstrates Significant and Sustained Quality of Life Benefits Across All Domains for the Majority of Patients with Urgency Urinary Incontinence at 24 Months [Press release]. https://bluewindmedical.com/newsroom/. 

References:

  1. Pizzol, D. et. al. Urinary incontinence and quality of life: a systematic review and meta analysis. Aging Clinical and Experimental Research. 2021; 33:25-35. https://doi.org/10.1007/s40520-020-01712-y