Not Yet RecruitingNot Applicable

Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence

55 participantsStarted 2026-05-01

Plain-language summary

Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18 years or older
✓. Primary indication of Fecal Incontinence (FI)
✓. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers

Exclusion criteria

✕. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis)
✕. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements
✕. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
✕. A female who is breastfeeding
✕. A female with a positive urine pregnancy test

What they're measuring

Performance/effectiveness - Improvement in Quality of Life scoring (FI)

Timeframe: 3 months

Performance/effectiveness - Improvement in patient satisfaction scoring (FI)

Timeframe: 3 months

Trial details

NCT IDNCT07499258

SponsorAxonics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12-01

Contact for this trial

Anna Selverian

714-262-1787 anna.selverian@bsci.com

View on ClinicalTrials.gov More Fecal Incontinence trials