R20 PMCF Study - FI Indication
Research type
Research Study
Full title
Post-Market Clinical Follow-up Study - INS Model 5101 (R20)
IRAS ID
371669
Contact name
Erum Shaikh
Contact email
Sponsor organisation
Axonic, Inc. (a Boston Scientific company)
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 19 days
Research summary
Bowel (faecal) incontinence — the inability to control bowel movements — is a common and distressing condition that significantly affects quality of life and is the second leading cause of nursing home placement in the United States1. Despite its impact, fewer than one-third of those affected seek medical care. Sacral Neuromodulation (SNM) — a treatment that uses a small implanted device to send gentle electrical pulses to a nerve near the base of the spine — is a guideline-recommended therapy for patients who have not responded to simpler treatments.
This study aims to assess the real-world safety, effectiveness, and patient benefit of the Axonics SNM System (Model 5101, also known as the R20), which is already commercially approved for use in Europe, the United States, Australia, and Canada1. A key advantage of the R20 over earlier devices is that it only needs recharging once every 6 to 10 months, rather than once a month. The study is a single-arm, prospective, open-label Post-Market Clinical Follow-up (PMCF) study — meaning all participants will receive the same treatment and data will be collected as it occurs in routine clinical practice.
Up to 55 adults aged 18 or over with a primary diagnosis of bowel incontinence will be enrolled across up to 15 hospital or clinical sites in Western Europe and the United States, including Sheffield Teaching Hospitals NHS Foundation Trust in the United Kingdom1. Participants will attend follow-up visits at 1–4 weeks, 3 months, 1 year, and 2 years after implantation, completing validated questionnaires on bowel symptoms, quality of life, and satisfaction with their treatment1. The primary measure of success will be a meaningful improvement in bowel incontinence symptoms at 3 months. Potential benefits include a reduction in bowel incontinence episodes and an improvement in quality of life. As with all implanted devices, there are known risks, including the possibility of infection, pain or discomfort at the implant site, device migration, and in some cases the need for further surgery to adjust or remove the device.
Participation in the study is entirely voluntary. Participants may withdraw at any time without this affecting their standard medical care. The study is funded by Boston Scientific/Axonics, Inc., and is led internationally by Mr. Keith Chapple, Consultant Colorectal Surgeon at Sheffield Teaching Hospitals NHS Foundation Trust.
REC name
Wales REC 6
REC reference
26/WA/0133
Date of REC Opinion
27 May 2026
REC opinion
Favourable Opinion