Revi System demonstrates positive two-year results for treating urgency urinary incontinence

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BlueWind Medical has announced the publication of 2-year results from its OASIS study in the March 2025 issue of the Journal of Urology. The study evaluates the effectiveness and safety of the Revi System, a minimally invasive implantable Tibial NeuroModulation (iTNM) device designed to treat urgency urinary incontinence (UUI).¹

The OASIS study followed 151 adult women with UUI, with primary efficacy and safety assessments conducted at 6, 12, and 24 months. A total of 97 participants completed the 2-year assessment. Results show that the Revi System offers sustained efficacy, a strong safety profile, and high patient satisfaction.²

Key findings include a durable reduction in UUI episodes, with 79% of participants experiencing at least a 50% decrease in symptoms and 56% achieving a 75% reduction. Additionally, 28% of patients reported being completely dry based on a three-day voiding diary. The study also found a significant reduction in large-volume urgency-related leaks, from 0.9 per day to 0.1 per day.²

Further data from the study reaffirmed these findings. The analysis demonstrated that 91% of participants experienced at least a 50% reduction in UUI episodes at one or more follow-up visits. Patient satisfaction remained high, with 97% of participants reporting feeling "better" to "very much better." Additionally, the study highlighted that the Revi System maintained comparable efficacy at 6, 12, and 24 months, supporting its long-term benefits. Importantly, no serious adverse events related to the device or procedure were reported, and the explant rate remained low at 2%.²

Beyond these primary outcomes, the study found that patients treated with the Revi System experienced improvements in overall quality of life. The reduction in urgency-related leaks significantly reduced the emotional burden associated with UUI, allowing participants greater confidence and independence in daily activities. According to the study, 62.9% of patients experienced a significant reduction in moderate-to-severe urgency episodes, and total voiding frequency was reduced from an average of 10 voids per day at baseline to 8.3 voids per day after 24 months of treatment.²

John Heesakkers, MD, chairman of the Department of Urology at Maastricht University Medical Center, emphasized the patient-centric nature of the Revi System. “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,” he said. “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.”¹

The study also highlights the need for non-pharmacologic treatments for UUI, especially in light of concerns regarding the potential link between anticholinergic medications and dementia. Revi is the first iTNM device approved for use without the requirement of failing more conservative therapies. It is supported by the recently updated 2024 guideline on the diagnosis and treatment of idiopathic overactive bladder from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction.¹

Moreover, according to the company, the Revi System distinguishes itself from other treatment options by eliminating the need for frequent battery replacements and reducing the risks associated with invasive surgeries. Unlike sacral neuromodulation devices, Revi does not require a permanently implanted power source, making it a more convenient and patient-friendly alternative. Its non-invasive, patient-controlled treatment method allows for therapy adjustments based on individual needs, further enhancing its appeal as a long-term solution.¹

Roger Dmochowski, MD, chief medical advisor at BlueWind Medical, reiterated the significance of the study’s findings. “The two-year study results affirm the Revi System’s significant impact in improving OAB and UUI symptoms and underscore its innovation and effectiveness as a minimally invasive neuromodulation option,” he said. “Our commitment remains steadfast to enhancing treatment options and elevating the quality of life for people grappling with UUI.”¹

References

1. Bluewind Medical. BlueWind Medical Announces Peer-Reviewed Data Showing Excellent Durability of Results for Revi^® System at Two Years. Businesswire. February 7, 2025. 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

2. 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. Published online November 25, 2024. doi:10.1097/JU.0000000000004328