Status:
RECRUITING
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
Lead Sponsor:
Axonics, Inc.
Conditions:
Overactive Bladder
Urinary Urgency Incontinence
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Detailed Description
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate c...
Eligibility Criteria
Inclusion
- Key
- Participants aged ≥ 18 years at the time of enrollment
- Able to complete bladder diaries and patient questionnaires
- Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
- 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
- Key
Exclusion
- Any patient that is not a suitable candidate per investigator discretion
- Recent prostate therapy or procedure within the last 6 months at the time of enrollment
- Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- Previously implanted with a sacral neuromodulation device, including inactive SNM devices
- Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
- Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment
- Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives at the discretion of the participating physician.
- Uncontrolled diabetes
- Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06511141
Start Date
October 22 2024
End Date
March 1 2028
Last Update
December 3 2025
Active Locations (13)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
2
Urology Associates
Fairhope, Alabama, United States, 36532
3
El Camino Health
Mountain View, California, United States, 94040
4
Tri Valley Urology
Murrieta, California, United States, 92562