F15 Recharge Free Axonics SNM System Clinical Study
Running, not enrolling · Not applicable
Conditions studied: Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI)
In brief
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.
Key facts
- Study ID
- NCT06186765
- Run by
- Axonics, Inc.
- People needed
- 144
- Starts
- 2023-12-08
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years or older
- 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
- 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.
You may not qualify if…
- 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)
- 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
- 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)
- History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- A female who is breastfeeding
- A female with a positive urine pregnancy test
Where it is running
- Hartford Healthcare — Waterford, Connecticut, United States
- Florida Gulf Clinical Research — Bradenton, Florida, United States
- East Coast Institute of Research — Jacksonville, Florida, United States
- Florida Bladder Institute — Naples, Florida, United States
- Atrium Health — Macon, Georgia, United States
- Minnesota Urology — Coon Rapids, Minnesota, United States
- Adult Pediatric Urology & Urogynecology — Omaha, Nebraska, United States
- Columbia University Medical Center — New York, New York, United States
- The Oregon Clinic — Portland, Oregon, United States
- Southern Shores Urogynecology — Myrtle Beach, South Carolina, United States
- Houston Colon — Houston, Texas, United States
- 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
Full record on ClinicalTrials.gov
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