Trial reportThe Journal of urology2025
Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence.
Trial report in The Journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03596671 (A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder), which is not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)
Who cites it
10 citing papers in PubMed.
- Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation from the Pivotal OASIS Study.The Journal of urology · 2026Trial
- Implantable tibial neuromodulation with an Anklet for overactive bladder: a review.World journal of urology · 2026Review
- Neuromodulation for Lower Urinary Tract Dysfunction: Mechanisms, Modalities, and Patient Selection.International urogynecology journal · 2026Review
- Impact of Revi® Implantable Tibial Neuromodulation on Quality of Life in Patients with Urgency Urinary Incontinence.International urogynecology journal · 2026Observational
- Comment on "Impact of Revi® Implantable Tibial Neuromodulation on Quality of Life in Patients with Urgency Urinary Incontinence".International urogynecology journal · 2026Article
- Technique for Implantable Tibial Nerve Stimulator Placement.International urogynecology journal · 2026Article
- Management of Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis.Current urology reports · 2026Review
- Tibial Nerve Stimulation: Recent Progress and Challenges.Current urology reports · 2026Review
- Emerging Implantable Tibial Nerve Stimulation Devices for Overactive Bladder.International neurourology journal · 2025Article
- Efficacy of the Revi system in treating urgency urinary incontinence.Nature reviews. Urology · 2025Article
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe BlueWind Medical Device, Revi, is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (ie, overactive bladder wet). The Revi System is the first Food and Drug Administration-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS (Overactive Bladder Stimulation System) study are presented. MATERIALS AND
methodsThe Revi System was implanted in 151 female participants. The primary efficacy and safety end points were assessed at 6 and 12 months, after which participants either consented to extend follow-up for long-term assessment of treatment durability and safety or they chose to exit the study.
resultsNinety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥50% reduction in urgency urinary incontinence episodes, demonstrated on a 3-day voiding diary). Importantly, therapeutic response was durable, with comparable effectiveness at 6, 12, and 24 months (response rates of 78%, 82%, and 79%, respectively). Participants who completed both the 6- and 24-month 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. In addition, high satisfaction and patient impression of improvement were reported, with 97% (88/91) of the participants satisfied with the therapy and 80% (78/97) feeling "much better" or "very much better." There were no serious adverse events related to the device or the procedure through 24 months.
conclusionsTwo-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile.
trial registrationClinicalTrials.gov Identifier: NCT03596671.
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