Authors' objectives: Overactive bladder syndrome (OAB) and urge urinary incontinence (UUI) are both conditions in which the bladder muscles can contract inappropriately, making people feel an urgent need to pass urine and sometimes resulting in leaks. The conditions can be embarrassing and affect a person’s quality of life. Around 7% of people in Wales are thought to be affected and the conditions are more commonly experienced by women and in the elderly. Prevalence is, however, likely to be under-reported due to the nature of the symptoms. An implantable tibial neuromodulation device (ITND) is a coin-sized device which is implanted into a patient’s ankle, alongside the tibial nerve. They can then be used at home at regular intervals, to provide stimulation to the nerve which helps control the bladder. It is hoped this will reduce symptoms associated with OAB and UUI including urgency and leaks, and be more convenient to patients as they can self-treat at home for longer periods, rather than regularly visiting hospital for percutaneous tibial nerve stimulation (TNS) over 12 weeks.

Authors' results and conclusions: The evidence identified showed that, overall, ITNDs did appear to have a positive impact on symptoms and outcomes related to both OAB and UUI, however the level of statistical significance was variable across publications. Additionally, device efficacy only appeared to be maintained as long as they were working and being used by study participants. A de novo cost effectiveness analysis showed that over a 10-year horizon, Revi (one of the ITND technologies identified) was estimated to be more costly and more effective than no treatment. However, with incremental cost-effectiveness ratios consistently higher than £20,000 per quality-adjusted life year, Revi was not estimated to be cost effective compared with no treatment. The cost effectiveness of Revi or other ITNDs compared with sacral neuromodulation (SNM) or Botox remains uncertain without head-to-head comparisons of these surgical treatments. Patient and Public Involvement (PPI) evidence showed OAB and UUI have a huge impact on patients' lives, and patients preferred less invasive, home-based, self-administered treatment where possible.

Authors' recommendations: ITNDs show promise for the treatment of urge urinary incontinence and/or overactive bladder, but the evidence is insufficient to support routine adoption. Single-arm studies show ITNDs improve symptoms, including number and volume of voids, urgency events and severity, leak events and severity, and nocturia. However, no comparative evidence was identified. Economic modelling suggests that ITND is not cost effective compared with no treatment. Cost effectiveness versus active comparators is uncertain. HTW recommends further research on the long-term effectiveness of ITNDs, comparative effectiveness and cost effectiveness.

Authors' methods: The Evidence Appraisal Report is based on a literature search (strategy available on request) for published clinical and economic evidence on the health technology of interest. It is not a full systematic review but aims to identify the best available evidence on the health technology of interest. Researchers critically evaluate and synthesise this evidence. We include the following clinical evidence in order of priority: systematic reviews; randomised trials; non-randomised trials. We only include evidence for “lower priority” evidence where outcomes are not reported by a “higher priority” source. We also search for economic evaluations or original research that can form the basis of an assessment of costs/cost comparison. We carry out various levels of economic evaluation, according to the evidence that is available to inform this.

Project Status: Completed

Year Published: 2025

URL for published report: https://healthtechnology.wales/reports-guidance/implantable-tibial-neuromodulation-devices/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Wales, United Kingdom

Organisation Name: Health Technology Wales

Contact Address: c/o Digital Health Care Wales, 21 Cowbridge Road East Cardiff CF11 9AD

Contact Name: Susan Myles, PhD

Contact Email: healthtechnology@wales.nhs.uk