F15 Recharge Free Axonics SNM System Clinical Study

Last updated: March 31, 2025
Sponsor: Axonics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fecal Incontinence

Bowel Dysfunction

Enuresis

Treatment

Axonics SNM System (Model 4101)

Clinical Study ID

NCT06186765
105-0108
  • Ages > 18
  • All Genders

Study Summary

Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years or older

  2. Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, orwho have failed conservative treatment

  3. Willing and capable to provide written informed consent and agrees to comply withspecified evaluations at clinical investigational sites and attend all follow-upassessments for up to 1 year.

Exclusion

Exclusion Criteria:

  1. Any significant medical condition that is likely to interfere with procedures,device operation, or likely to confound evaluation of endpoints (exclusion ofneurological conditions such as multiple sclerosis)

  2. Any psychiatric or personality disorder that is likely to interfere with proceduresat the discretion of the participating physician; this may include poorunderstanding or compliance with requirements

  3. Previously underwent an external sacral neuromodulation (SNM) trial and was deemed anon-responder or was previously implanted with a sacral neuromodulation device anddid not get therapeutic benefit (a non-responder)

  4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone

  5. A female who is breastfeeding

  6. A female with a positive urine pregnancy test

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Axonics SNM System (Model 4101)
Phase:
Study Start date:
December 08, 2023
Estimated Completion Date:
June 30, 2026

Study Description

A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, model 4101. The product is currently marketed under the name F15 in the United States.

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