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Clinical Trials in the USA / NCT07499258
Recruiting Observational

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

NCT07499258 · tracked via the Priya Life Science USA tracker
Sponsor
Axonics, Inc
Phase
Observational
Started
2026-07-02
Last updated
2026-10-13

Condition(s) studied

Fecal Incontinence

Investigational drug(s) / intervention(s)

Axonics SNM System INS Model 5101 (R20)

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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".

Trial sites (5)

FacilityCityRegionStatus
Columbia University Medical Center New York New York Not Yet Recruiting
The Christ Hospital Cincinnati Ohio Recruiting
Female Urology of Nashville Research Partnership Nashville Tennessee Recruiting
Houston Colon Houston Texas Recruiting
Northern General Hospital Sheffield United Kingdom Recruiting

More Axonics, Inc. trials in the USA

Aquarius Pilot Study to Evaluate the New Axonics Trial System Recruiting
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB Recruiting
F15 Recharge Free Axonics SNM System Clinical Study Active, not recruiting
Sacral Neuromodulation for Male Overactive Bladder (MOAB) Recruiting

Other trials for the same condition

Pelvic Health Electrically Evoked Recording (PEER) 2 Study Recruiting
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury Active, not recruiting
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07499258 on ClinicalTrials.gov ↗ ← All trials in the USA