NCT07499258

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
43mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Dec 2029

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

March 24, 2026

Last Update Submit

May 11, 2026

Conditions

Fecal Incontinence

Keywords

Fecal IncontinenceSacral Neuromodulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Performance/effectiveness - Improvement in Quality of Life scoring (FI)

    12 months, 24 months

  • Performance/effectiveness - Improvement in Quality of Life scoring (FI)

    3 months, 12 months, 24 months

  • Performance/effectiveness - Improvement in patient satisfaction scoring (FI)

    12 months

  • Adverse event reporting (Safety)

    3 months, 12 months, 24 months

Study Arms (1)

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)

Interventions

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.

Fecal Incontinence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Colon

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Keith Chapple, MD

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Beaudoint

CONTACT

+32 (0) 479 90.41.63caroline.beaudoint@bsci.com

Gita Ghadimi, OD

CONTACT

1-949-981-4366gita.ghadimi@bsci.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations

US(1)