Revi is a novel implantable tibial neuromodulation (iTNM) system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (UUI). 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.
The 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.
Ninety-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 UUI 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 (PGI-I) scale. No device-related or procedure-related serious adverse events were reported through 36 months.
In women with UUI, Revi—an iTNM 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.
Urgency urinary incontinence (UUI) is both common and significantly bothersome, affecting the quality of life of millions worldwide.1 Treatment options for UUI were once limited, but recent advancements have led to innovative options to address this onerous condition.2 Neuromodulation in particular has advanced from an involved, invasive surgical option of last-resort to a simple, minimally invasive procedure requiring only local anesthesia.3
Traditional sacral nerve stimulation (SNS) therapies were often associated with high rates of surgical reintervention due to decreased efficacy over time from possible lead migration or breakage and implantable pulse generator (IPG) replacements due to pain, infection, or battery depletion.3-5 Advances in technology have led to fewer revisions, but these potential issues remain.3 Percutaneous tibial nerve stimulation (PTNS) has been shown to be efficacious for mild to moderate OAB but with limitations of frequent office visits (weekly-to-monthly) to achieve and maintain clinical response.6 Implantable tibial neuromodulation (iTNM), with an external battery-operated power source, has the potential to provide long-term symptom control with convenient at-home therapy and few side effects or future need for revisions.
The Revi System is a minimally invasive iTNM system for the management of UUI with sophisticated stimulation programming capabilities (Figure 1). This manuscript presents 3-year efficacy, safety, and tolerability of the Revi System for the treatment of UUI.
Figure 1. The Revi System comprised an active implantable unit, an external wearable unit which transmits energy through magnetic coupling to the implant when the system is in use, and a clinician programmer.
The therapeutic landscape for urgency urinary incontinence (UUI) has expanded considerably over the past decade, yet durability of effect remains the critical benchmark for any neuromodulation strategy. The three-year results of the OASIS pivotal trial address this benchmark directly, and the findings deserve careful attention.
The OASIS study is a prospective, multicentre, single arm, open-label pivotal clinical study evaluating the efficacy and safety of the Revi System in women with UUI. A total of 151 participants were implanted in the initial OASIS trial.
The Revi system represents a conceptual departure from conventional neuromodulation. As an implantable tibial neuromodulation (iTNM) device powered by a patient-controlled external wearable, it combines the targeting precision of an implant with the flexibility of on-demand activation. Crucially, it was designed for use outside the traditional “refractory” patient population, a shift in eligibility that, if validated by long-term data, could substantially alter how and when we escalate treatment in OAB.
The three-year outcomes are compelling. A 79% therapeutic response rate, defined as ≥50% reduction in UUI episodes, was sustained at 36 months, mirroring the 78% observed at six months. This stability over time is not trivial. Most neuromodulation data suffer from progressive attrition of effect, dropout, or device-related complications that erode early enthusiasm. Here, 63% of patients achieved a ≥75% reduction, and 95% reported satisfaction with therapy. The safety profile remained excellent, with no device or procedure-related serious adverse events reported through three years.
Yet several questions deserve to be held alongside these results. The OASIS study enrolled exclusively women, limiting generalisability. It is a single-arm, open-label trial without a comparator arm. The absence of a head-to-head comparison against sacral neuromodulation or percutaneous tibial nerve stimulation (PTNS) leaves the relative positioning of Revi within the neuromodulation hierarchy unresolved. Response was assessed in completers, a methodological choice that may introduce favourable bias.
Beyond the trial design, a broader question emerges: what does “response” mean in UUI? A ≥50% reduction in episodes is a validated and clinically meaningful threshold, but it is not continence. The 28% dry rate at 36 months reminds us that for a significant proportion of patients, neuromodulation remains a management strategy, not a cure.
These caveats do not diminish the clinical significance of the OASIS three-year data. They contextualise it. What this study contributes is something the field genuinely needed: evidence that implantable tibial neuromodulation can sustain its effect over a clinically meaningful timeframe, with a safety profile that supports broader use. For the functional urologist, the message is that Revi has earned a place in the conversation, not as a replacement for established modalities, but as a legitimate and durable option, particularly for patients who may not yet meet traditional refractory criteria.
The next step the field requires is a prospective, randomised comparison. Until then, patient selection and shared decision-making remain the true arbiters of where this technology belongs in our practice.
For European clinicians, enthusiasm must be tempered by the practical reality that Revi is still awaiting CE marking and is therefore not yet available for routine clinical use. However, should regulatory follow, the technology would add a valuable tool to an increasingly diverse therapeutic landscape, allowing treatment decisions to be guided less by the limitations of current options and more by the individual needs and preferences of patients. Expanding the spectrum of minimally invasive therapies is ultimately what enables a truly patient-centred approach to OAB care.