Recruiting

Rechargeable Neurostimulator

Sponsor:

Axonics, Inc.

Code:

NCT07499258

Conditions

Fecal Incontinence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Axonics SNM System INS Model 5101 (R20)

Study Details

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.

Conditions

Fecal Incontinence

Study ID

NCT07499258

Start date

Jul 2, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Arms

Fecal Incontinence

Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms.

Interventions

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.

Primary outcome measure

  • Performance/effectiveness - Improvement in Quality of Life scoring (FI) [ Time Frame: 3 months ]
  • Performance/effectiveness - Improvement in patient satisfaction scoring (FI) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Caroline Beaudoint

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

Gita Ghadimi, OD

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

Locations

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Rodger Rothenberger, MD

Female Urology of Nashville Research Partnership

Recruiting

Nashville, Tennessee, United States, 37209

Principal Investigator:

Ly Hoang Roberts, MD

Houston Colon

Recruiting

Houston, Texas, United States, 77030

Contacts

Jimena Alcocer-Barrios

713-790-0600jalcocerbarrios@houstoncolon.com

Principal Investigator:

Eric M. Haas, MD

More Information

Sponsor

Axonics, Inc.

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Fecal Incontinence
  • Sacral Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Axonics, Inc. on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.