Fecal IncontinenceNCT07499258
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
An observational study of Fecal Incontinence, run by Axonics, Inc. at 5 sites in 2 countries.
Trial summary
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Axonics SNM System INS Model 5101 (R20)
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 Jul 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 or older, diagnosed with FI as indicated per commercially available IFU.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Sharon Lamping, CCRC
Rodger Rothenberger, MD
- Recruiting
Houston Colon
Houston, Texas, 77030
Jimena Alcocer-Barrios, 713-790-0600, jalcocerbarrios@houstoncolon.com
Eric M. Haas, MD
- Recruiting
Female Urology of Nashville Research Partnership
Nashville, Tennessee, 37209
Esha Ramjee
Ly Hoang Roberts, MD
- Not yet recruiting
Columbia University Medical Center
New York, New York, 10032
Emily Breneisen, 212-342-4102, eb3709@cumc.columbia.edu
Marco B. Zoccali, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Northern General Hospital
Sheffield
Caroline Steele
Keith Chapple, Mr.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- Axonics SNM System INS Model 5101 (R20)
- Keywords
- Fecal Incontinence, Sacral Neuromodulation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axonics SNM System INS Model 5101 (R20)Device
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 group | Role | What they receive |
|---|---|---|
| Fecal Incontinence | Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms. Receives: Device: Axonics SNM System INS Model 5101 (R20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 3 months
Secondary outcomes (4)
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Demonstrate any improvement in CCF-FIS at 1-year 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.
Measured: 12 months
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Demonstrate an improvement in Fecal Incontinence Quality of Life (FIQOL) at 3 months, and 1-year 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.
Measured: 3 months, 12 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".
Measured: 12 months
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Measured: 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start2 Jul 2026
- Primary completionAug 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Chapple, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499258
- Sponsor's protocol ID
- 105-0169
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)
- ClinicalTrials.gov ID
- NCT07499258
- Acronym / sponsor ID
- 105-0169
- Conditions
- Fecal Incontinence
- Keywords
- Fecal Incontinence, Sacral Neuromodulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Axonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Incontinence | – | Device: Axonics SNM System INS Model 5101 (R20)Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 or older, diagnosed with FI as indicated per commercially available IFU.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Fecal Incontinence |
Primary outcome
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Time frame: 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)
Time frame: 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".
4 secondary outcomes
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Time frame: 12 months
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
Time frame: 3 months, 12 months
Performance/effectiveness - Improvement in patient satisfaction scoring (FI)
Time frame: 12 months
Adverse event reporting (Safety)
Time frame: 3 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keith Chapple, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence, run by Axonics, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Beaudoint (+32 (0) 479 90.41.63, caroline.beaudoint@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance/effectiveness - Improvement in Quality of Life scoring (FI) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.