Implantable tibial neuromodulation with an Anklet for overactive bladder: a review

Overactive bladder (OAB) is a prevalent chronic condition associated with substantial impairment in quality of life (QoL). Although conservative and pharmacological therapies remain first- and second-line treatment options, long-term adherence and efficacy are often limited by variable treatment response. Implantable tibial neuromodulation (iTNM) using an external wearable ankle stimulator has emerged as a minimally invasive therapeutic strategy combining the durability of implantable neuromodulation with the convenience of wireless home-based therapy. This review provides an overview of currently investigated iTNM systems incorporating an external wearable stimulator anklet for the treatment of OAB.

A narrative review of the literature was performed on iTNM systems using an external anklet stimulator. Studies evaluating clinical efficiacy, safety, durability, device characteristics and patient-centered outcomes were reviewed.

14 studies were included. Three iTNM systems incorporating an external external anklet stimulator were identified: the Urgent-SQ, Protect PNS, and the Revi system (formerly RENOVA iStim). Clinically meaningful improvements were observed in urgency symptoms, urinary frequency, urge urinary incontinence (UUI) episodes, and quality of life (QoL). Safety outcomes were generally favorable, with adverse events (AEs) predominantly mild and transient. Implant migration or dislocation, revision procedures, and device-related serious adverse events (SAE) were infrequently reported.

Current evidence suggests that iTNM using an external anklet stimulator may provide an effective and minimally invasive treatment option for patients with refractory OAB and UUI, with encouraging safety and durability outcomes. Although further comparative and long-term studies are warranted, iTNM appears to be an relevant addition to the third-line OAB management.