Revi system for urinary incontinenceRevi, an implantable tibial neuromodulation system powered by a patient-controlled, external wearable ankle device, demonstrates durable efficacy, excellent safety profile, and high patient satisfaction in women with urgency urinary incontinence (UUI), a study has shown.
“Additional advantages include the small size of the electrode requiring minimal implanted hardware; the capability of intraoperative testing to ensure proper placement and stimulation response; the elimination of a formal ‘trial phase’ before implantation; stimulation programming capabilities to enhance individualized efficacy over time, yet operationally simple for the patient who is willing to be engaged in their therapy; and an external battery-operated wearable control device, thus eliminating future needs for surgical battery replacements,” the investigators said.
One hundred fifty-one women received the Revi system, of whom 140 (93 percent) completed the 12-month study, and 119 (85 percent) met the screening criteria and consented to the 36-month extension study. Ninety of the 119 participants (76 percent) completed the 36-month assessment, of whom 71 (79 percent) responded to therapy (≥50-percent reduction in urgency urinary incontinence episodes, demonstrated on a 3-day voiding diary). [J Urol 2026;216:219-229]
Participants reported sustained therapeutic responses and durable effectiveness between 6 and 36 months (response rates, 78 percent and 79 percent, respectively). Most (83/87, 95 percent) of these women also reported therapeutic satisfaction, and the majority (74/90, 82 percent) reported feeling “much better” or “very much better” based on the Patient Global Impression of Improvement scale.
“This response rate is slightly higher than response rates reported in a recent meta-analysis, where UUI response rates for other implanted neuromodulation devices (eg, percutaneous tibial nerve stimulation and sacral nerve stimulation) were 68 percent to 72 percent. [Adv Ther 2025;42:10-35]
“Although the system requires patient engagement with use of the external Revi wearable ankle controller, this seemingly did not deter participants… Furthermore, it ultimately provides the individual greater control over treatment frequency, intensity, and programming, while obviating the future need for battery replacement surgeries,” they added.
Safety profile
Device-related adverse events (AEs) were low at 10 percent throughout the 36-month study. The explant rate was also low at 3 percent, with no surgical revisions. Nineteen (12.6 percent) procedure-related AEs occurring more than once included mild-to-moderate wound complication (n=4), infections (n=2), and impaired healing (n=2). No serious AEs were reported.
“This highlights that fewer implanted components, direct fascia suturing, and an external battery reduces AEs and the necessity for subsequent revision surgery for issues such as lead migration or battery depletion, setting the Revi system apart from other neuromodulation alternatives currently available,” the investigators said.
By comparison, users of eCoin, another US Food and Drug Administration-approved implantable tibial neuromodulation device, reported 20-percent device-related AEs at 2 years. [Urology 2024;194:17-12]
These findings demonstrate “similar efficacy outcomes at 3 years to published neuromodulation studies, with the advantage of minimal implanted hardware, the capability of intraoperative testing to ensure proper placement and stimulation response, and stimulation programming capabilities to enhance individualized efficacy over time,” the investigators said.
This study had certain limitations. Firstly, the study was neither randomized nor blinded. Secondly, the long-term follow-up was conducted after some patients had already exited the study, contributing to loss to follow-up.