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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Axonics SNM System INS Model 5101 (R20)

Detailed Description

Post-market clinical follow-up for continued assessment of safety and performance of the Axonics INS Model 5101 (R20). The study will include participants with the primary diagnosis of fecal incontinence who are eligible to receive the rechargeable R20 device as per the commercially available IFU.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Caroline Beaudoint; Phone Number: +32 (0) 479 90.41.63; Email: caroline.beaudoint@bsci.com
• Study Contact Backup: Name: Gita Ghadimi, OD; Phone Number: 1-949-981-4366; Email: gita.ghadimi@bsci.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Colon
      • Contact: Jimena Alcocer-Barrios; Phone Number: 713-790-0600; Email: jalcocerbarrios@houstoncolon.com
      • Principal Investigator: Eric M. Haas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 or older, diagnosed with FI as indicated per commercially available IFU.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fecal Incontinence; Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance/effectiveness - Improvement in Quality of Life scoring (FI)	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.	3 months
Performance/effectiveness - Improvement in patient satisfaction scoring (FI)	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".	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event reporting (Safety)	Device related, procedure-related and all serious adverse events	3 months, 12 months, 24 months
Performance/effectiveness - Improvement in Quality of Life scoring (FI)	Demonstrate any improvement in CCF-FIS at 1-year and 2-years post-implant compared to baseline. 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.	12 months, 24 months
Performance/effectiveness - Improvement in Quality of Life scoring (FI)	Demonstrate an improvement in Fecal Incontinence Quality of Life (FIQOL) at 3 months, 1-year, and 2-years post-implant compared to baseline. Fecal Incontinence Quality of Life (FIQOL) includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.	3 months, 12 months, 24 months
Performance/effectiveness - Improvement in patient satisfaction scoring (FI)	Participant Satisfaction with Treatment and Charging Questionnaire at 1-year post-implant compared to baseline. 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".	12 months

Collaborators and Investigators

• Sponsor: Axonics, Inc.
• Investigators: Principal Investigator: Keith Chapple, MD, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Fecal Incontinence; Sacral Neuromodulation
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 105-0169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes