An observational study in Fecal Incontinence, sponsored by Axonics, Inc.. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Axonics, Inc. (part of Boston Scientific Corporation) · Observational
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Post-market clinical follow-up for continued assessment of safety and performance of the Axonics INS Model 5101 (R20). The study will include participants with the primary diagnosis of fecal incontinence who are eligible to receive the rechargeable R20 device as per the commercially available IFU.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
This study's planned enrollment of 55 is below the median of 92 across 66 observational studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Axonics, Inc. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
First submitted after Axonics, Inc. became part of Boston Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 or older, diagnosed with FI as indicated per commercially available IFU.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms.
Device: Axonics SNM System INS Model 5101 (R20)
Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
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.
Time frame: 3 months
Performance/effectiveness - Improvement in patient satisfaction scoring (FI)
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".
Time frame: 3 months
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Demonstrate any improvement in CCF-FIS at 1-year post-implant compared to baseline. 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.
Time frame: 12 months
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Demonstrate an improvement in Fecal Incontinence Quality of Life (FIQOL) at 3 months, and 1-year post-implant compared to baseline. Fecal Incontinence Quality of Life (FIQOL) includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.
Time frame: 3 months, 12 months
Performance/effectiveness - Improvement in patient satisfaction scoring (FI)
Participant Satisfaction with Treatment and Charging Questionnaire at 1-year post-implant compared to baseline. 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".
Time frame: 12 months
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Time frame: 3 months, 12 months
Started Jul 2026 (actual). Primary completion is estimated for Aug 2027, 13 months after the start.
Of 32 observational studies under Fecal Incontinence, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 51. This study's planned 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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