Status:
RECRUITING
F15 Recharge Free Axonics SNM System Clinical Study
Lead Sponsor:
Axonics, Inc.
Conditions:
Urinary Urge Incontinence (UUI)
Urinary Frequency (UF)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06186765
Start Date
December 8 2023
End Date
March 1 2027
Last Update
December 23 2025
Active Locations (16)
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1
Hartford Healthcare
Waterford, Connecticut, United States, 06385
2
Florida Gulf Clinical Research
Bradenton, Florida, United States, 34205
3
East Coast Institute of Research
Jacksonville, Florida, United States, 32216
4
Florida Bladder Institute
Naples, Florida, United States, 34109