F15 Recharge Free Axonics SNM System Clinical Study
Purpose
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.
Conditions
- Urinary Urge Incontinence (UUI)
- Urinary Frequency (UF)
- Fecal Incontinence (FI)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Single Arm - product does not have Communauté Européenne (CE) Mark in Europe |
Observational |
|
Recruiting Locations
Hartford Healthcare
Waterford, Connecticut 06385
Waterford, Connecticut 06385
Contact:
Isabel Michalak
Isabel Michalak
Columbia University Medical Center
New York, New York 10032
New York, New York 10032
Contact:
Natalie Marcin
Natalie Marcin
Southern Shores Urogynecology
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Contact:
Stephanie McCarty
Stephanie McCarty
Houston Colon
Houston, Texas 77030
Houston, Texas 77030
Contact:
Jimena Alcocer-Barrios
Jimena Alcocer-Barrios
More Details
- NCT ID
- NCT06186765
- Status
- Recruiting
- Sponsor
- Axonics, Inc.
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 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.