F15 Prospective Study, Version A
Research type
Research Study
Full title
Prospective, non-randomized, multicenter clinical evaluation of the recharge free Axonics SNM System (INS Model 4101)
IRAS ID
342951
Contact name
Gita Ghadmini
Contact email
Sponsor organisation
Axonics Inc,
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
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.
REC name
West of Scotland REC 4
REC reference
24/WS/0092
Date of REC Opinion
16 Sep 2024
REC opinion
Further Information Favourable Opinion