Sacral Neuromodulation for Male Overactive Bladder (MOAB)
NCT ID: NCT06511141
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-10-22
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Post-prostatectomy
History of radical prostatectomy for cancer treatment at least 6 months prior to enrollment
Axonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Radiation
History of radiation for cancer treatment at least 6 months prior to enrollment
Axonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Benign Prostatic Hyperplasia (BPH)
History of cytoreductive BPH surgery at least 6 months prior to enrollment
Axonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Interventions
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Axonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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. 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
18 Years
MALE
No
Sponsors
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Axonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Noblett, MD
Role: STUDY_DIRECTOR
Axonics, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Urology Associates
Fairhope, Alabama, United States
El Camino Health
Mountain View, California, United States
Tri Valley Urology
Murrieta, California, United States
University of Miami
Miami, Florida, United States
Louisiana State University
New Orleans, Louisiana, United States
WK Clinical Research
Shreveport, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Utica Park Urology
Tulsa, Oklahoma, United States
Urology Partners of North Texas (UPNT)
Arlington, Texas, United States
Texas Oncology
Houston, Texas, United States
Potomac Urology
Woodbridge, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Alisha Hitt
Role: primary
Pam Manley
Role: primary
Letoya Craig
Role: backup
Annette West
Role: primary
Vivian Cabral Perez
Role: primary
Anita Deeds
Role: backup
Maria N Odrosgoitia
Role: primary
Elena Cortizas
Role: backup
Jaya Mishra, PhD
Role: primary
Sherry Stephens
Role: primary
Carter Day
Role: primary
Imani Lucas
Role: primary
Alex Heinze, PA-C
Role: primary
Melissa Howell
Role: primary
Ginger Butterworth
Role: backup
Annelise Marsh
Role: primary
Other Identifiers
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105-0141
Identifier Type: -
Identifier Source: org_study_id