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Clinical Trials in the UK / NCT06186765
Active, not recruiting Not applicable

F15 Recharge Free Axonics SNM System Clinical Study

NCT06186765 · tracked via the Priya Life Science UK tracker
Sponsor
Axonics, Inc
Phase
Not applicable
Started
2023-12-08
Last updated
2026-10-13

Condition(s) studied

Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Fecal Incontinence (FI)

Investigational drug(s) / intervention(s)

Axonics SNM System (Model 4101)

Axonics SNM System (Model 4101): Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, or who have failed conservative treatment 3. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year. Exclusion Criteria: 1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis) 2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements 3. Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did 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

Primary outcome measure(s)

  • Performance/Effectiveness - Improvement in Quality of Life scoring (OAB) — 3 months
    International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
  • Performance/Effectiveness - Improvement in Fecal Incontinence Survey — 3 months
    Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
  • Adverse event reporting (Safety) — 3 months
    Device-related, procedure-related and all serious adverse events

Trial sites (16)

FacilityCityRegionStatus
Hartford Healthcare Waterford Connecticut
Florida Gulf Clinical Research Bradenton Florida
East Coast Institute of Research Jacksonville Florida
Florida Bladder Institute Naples Florida
Atrium Health Macon Georgia
Minnesota Urology Coon Rapids Minnesota
Adult Pediatric Urology & Urogynecology Omaha Nebraska
Columbia University Medical Center New York New York
The Oregon Clinic Portland Oregon
Southern Shores Urogynecology Myrtle Beach South Carolina
Houston Colon Houston Texas
Erasmus Medical Center Rotterdam Netherlands
Queen Elizabeth Hospital Birmingham United Kingdom
Bristol Urological Institute Bristol United Kingdom
University College London Hospital London United Kingdom
Northern General Hospital Sheffield United Kingdom

More Axonics, Inc. trials in the UK

Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence Recruiting
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB Recruiting

Other trials for the same condition

PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06186765 on ClinicalTrials.gov ↗ ← All trials in the UK