Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Nov 2025
In plain English
AI plain-English summary
A clinical trial will test whether a new version of an implanted nerve stimulator for bladder and bowel control can work without needing patients to recharge it every month. Current sacral neuromodulation (SNM) devices require patients to recharge a battery at home, which can be burdensome and lead to inconsistent therapy. The new Axonics system uses a non-rechargeable primary cell battery, eliminating the need for monthly recharging while delivering the same electrical stimulation to the sacral nerve. This matters because many patients with overactive bladder or faecal incontinence struggle with the recharging routine, and some stop using the device as a result. If the trial shows the non-rechargeable system is safe and effective, it could simplify daily life for thousands of people with these conditions. Patients would no longer need to remember to charge their implant, potentially improving adherence and quality of life. The change is in the power source, not the therapy itself—the mechanism of action and stimulation waveform remain identical to previous models. The study will follow participants for one year to assess safety and performance.
View original technical description
Sacral Neuromodulation (SNM) is a recommended treatment for Overactive Bladder (OAB) including urinary urgency incontinence (UUI) and urinary frequency (UF), and faecal incontinence (FI). Long-term data support the safety, efficacy, and durability of the therapy. The Axonics SNM system is indicated for Urinary Control and for Bowel Control. This investigation will be a multi-centre, prospective, non-randomized, single arm trial, with up to 55 participants for each indication, OAB or FI will be enrolled. INS Model 4101, also known as F15 is a non-rechargeable system (due to using primary cell battery), whereas previous Axonics neurostimulators use a rechargeable battery source that requires monthly recharging by the patient. The mechanism of action is identical in that the therapy is delivered to the sacral nerve, typically the 3rd sacral nerve root. Model 4101 uses the same exact stimulation waveform as the previous Axonics models.The objective of this investigation is to assess the safety and performance/effectiveness of the recharge free Axonics SNM System.Participants with primary diagnosis of OAB and FI who require an Axonics SNM device will be included. Participants must meet the eligibility requirements specified in this protocol. The study population will comprise of adults age 18 or older, diagnosed with OAB including UUI and/or UF diagnosed with FI. Enrolled participants will be followed in accordance with the follow-up schedule and included in all study analysis. Follow-up visits will be made at 1-4 week(s) per site’s standard of care, 3 months, 6 months, 9 months (check-in call only), and 1 year.
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