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

Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1. 18 years or older
2. Primary indication of Fecal Incontinence (FI)
3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers

Exclusion Criteria:

1. 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)
2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements
3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
4. A female who is breastfeeding
5. A female with a positive urine pregnancy test

About the study

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

What is being tested

• Axonics SNM System INS Model 5101 (R20) (device)

Sponsor: Axonics, Inc. · Participants: 55 · Started: Jul 2, 2026

Contact the study team

• Caroline Beaudoint · Phone: +32 (0) 479 90.41.63
• Gita Ghadimi, OD · Phone: 1-949-981-4366

Official record on ClinicalTrials.gov — NCT07499258

Locations in the U.S.

Conditions

• Fecal Incontinence

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.