Implantable tibial neuromodulation devices
Topic Status Complete
Implantable tibial neuromodulation devices for treatment of urge urinary incontinence
Outcome of the appraisal
Implantable tibial neuromodulation devices (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.
Why was this topic appraised?
Overactive bladder syndrome (OAB) is a common condition where the bladder muscles contract inappropriately. Some people with OAB feel an urgent need to pass urine and experience leaks before they reach the toilet, known as urge urinary incontinence (UUI). Around 7% of people in Wales are thought to be affected by these conditions, which are more commonly experienced by women and older people. Non-surgical approaches to treatment include lifestyle changes, pelvic floor exercises, bladder training and medication. If these options do not manage symptoms well, patients can consider procedures such as sacral neuromodulation (SNM) and botulinum toxin A (Botox). ITNDs comprise a small implant placed in the ankle and a wearable ankle band, which is used to stimulate the tibial nerve and help control the bladder. ITNDs can be used for self-treatment at home.
A device manufacturer submitted this topic for review to HTW.
Plain language summary
Urge urinary incontinence (UUI) is a sudden and urgent need to pass urine. It can occur several times during the day and at night. Urine may leak from the bladder before reaching the toilet. UUI is primarily caused by contractions in the muscles of the bladder. This can be the result of weak pelvic floor muscles, nerve damage, an infection, low levels of oestrogen or a heavier body weight.
Implantable tibial neuromodulation devices work by using electrical signals to help control these contractions. The device is implanted into the ankle and patients can administer treatments at home.
Health Technology Wales looked for evidence on implantable tibial neuromodulation devices for treatment of urge urinary incontinence. Implantable tibial neuromodulation devices show promise for the treatment of urge urinary incontinence and/or overactive bladder, but the evidence is insufficient to support routine adoption.
Topic Exploration Report
TER535 05.2024
Evidence Appraisal Report
EAR066 05.2025
Guidance
GUI066 05.2025
Health Technology Wales Partners
