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โ† Trials
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Sacral Neuromodulation for Male Overactive Bladder (MOAB)

RecruitingNAAges 18 Years - anyMaleAxonics, Inc.
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In plain words

What the trial is, and whether it could suit you

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Participants aged โ‰ฅ 18 years at the time of enrollment 2. Able to complete bladder diaries and patient questionnaires 3. Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)). 4. 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 Criteria: 1. Any patient that is not a suitable candidate per investigator discretion 2. Recent prostate therapy or procedure within the last 6 months at the time of enrollment 3. 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) 4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices 5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS) 6. Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment 7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician 8. 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. 9. Uncontrolled diabetes 10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
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What it tests

  • Axonics SNM System
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Where

23 sites
University of Alabama at Birmingham
Birmingham, United States
Urology Associates
Fairhope, United States
Mayo Clinic
Scottsdale, United States
USNC
Mountain View, United States
Tri Valley Urology
Murrieta, United States
University of California San Francisco
San Francisco, United States
University of Miami
Miami, United States
AdventHealth
Orlando, United States

โ€ฆand 15 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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