Axonics R20 Study for Fecal Incontinence
This study is looking at how well the Axonics SNM System INS Model 5101 (R20) works for people with fecal incontinence (accidental bowel leakage). The R20 is a rechargeable implanted device. The study wants to see if this device improves your quality of life and how satisfied you are with the treatment. You might be able to join if you are 18 or older, have fecal incontinence, and are willing to follow the study's instructions. The study is currently unclear on its recruitment status and plans to include 55 participants.
- Study design
- This is an observational study, meaning researchers will follow participants who are already using the Axonics R20 device. It is a single-arm, open-label study, meaning all participants receive the same treatment and everyone knows what treatment is being given. The study plans to enroll 55 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life and satisfaction will be measured at 3 months after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Keith Chapple, MD · PRINCIPAL_INVESTIGATOR · Sheffield Teaching Hospitals NHS Foundation Trust
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Performance/effectiveness - Improvement in Quality of Life scoring (FI)3 months
Short-term FI improvement demonstrated by Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
- Performance/effectiveness - Improvement in patient satisfaction scoring (FI)3 months
Short-term FI improvement demonstrated by Participant Satisfaction with Treatment and Charging Questionnaire. Participants will indicate satisfaction with SNM therapy for treatment of their FI symptoms based on a 7-point Likert scale ranging from "Very satisfied" to "Very dissatisfied".