Trial reportThe Journal of urology2026
Three-Year Efficacy and Safety of Revi Implantable Tibial Neuromodulation from the Pivotal OASIS Study.
Trial report in The Journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- A Review of Minimally Invasive Therapies for Men with Overactive Bladder.Current urology reports · 2026Review
- Implantable tibial neuromodulation with an Anklet for overactive bladder: a review.World journal of urology · 2026Review
- Efficacy and safety of an implantable tibial neuromodulation system for overactive bladder with urgency urinary incontinence: an open-label, single arm trial.Frontiers in urology · 2026Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeRevi 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. The Revi System (manufactured by BlueWind Medical) is the first FDA-cleared implantable neuromodulation device that can be used in traditionally nonrefractory patients. Three-year follow-up results from the pivotal FDA-approval trial, the OASIS Study, are presented. MATERIALS AND
methodsThe Revi System was implanted in 151 women. The primary efficacy and safety end points were assessed at 6 and 12 months, respectively; thereafter, participants were consented to extend follow-up to 3 years for assessments of long-term treatment durability and safety.
resultsNinety-three percent (140/151) completed the 12-month study, and 85% (119/140) met screening criteria and consented to the 36-month extension study. Ninety participants (76%, 90/119) completed the 36-month assessment, and 79% (71/90) were therapy responders (≥50% reduction in urgency urinary incontinence episodes, demonstrated on a 3-day voiding diary). Sustained therapeutic responses were reported, with durable effectiveness between 6 and 36 months (response rates of 78% and 79%, respectively). Notably, 95% (83/87) reported therapeutic satisfaction, and 82% (74/90) reported feeling "much better" or "very much better" based on the Patient Global Impression of Improvement scale. No device-related or procedure-related serious adverse events were reported through 36 months.
conclusionsIn women with urgency urinary incontinence, Revi-an implantable tibial neuromodulation system powered by a patient-controlled, external wearable ankle device-showed meaningful and durable efficacy, high patient satisfaction, and an excellent safety profile through 3 years.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.