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

Starting soon

Conditions studied: Fecal Incontinence

In brief

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

Key facts

Study ID

NCT07499258

Run by

Axonics, Inc.

People needed

55

Starts

2026-07-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University Medical Center — New York, New York, United States
• Houston Colon — Houston, Texas, United States

Full record on ClinicalTrials.gov

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