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 (4)
Facility
City
Region
Status
Columbia University Medical Center
New York
New York
Not Yet Recruiting
Female Urology of Nashville Research Partnership
Nashville
Tennessee
Recruiting
Houston Colon
Houston
Texas
Recruiting
Northern General Hospital
Sheffield
United Kingdom
Not Yet 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.
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