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Sacral Neuromodulation for Male Overactive Bladder (MOAB)
NCT06511141 · Axonics, Inc.
In plain English
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Official title
Sacral Neuromodulation for Male Overactive Bladder
About this study
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 cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).
Eligibility criteria
Key Inclusion Criteria:
1. Participants aged ≥ 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
Study design
Enrollment target: 150 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-10-22
Estimated completion: 2028-12
Last updated: 2026-04-15
Interventions
Device: Axonics SNM System
Primary outcomes
- • Adverse event reporting (Safety) (6 months, 1 year)
- • Performance/Effectiveness - Reduction in UUI or UF episodes (6 months, 1 year)
Sponsor
Axonics, Inc. · industry
Contacts & investigators
ContactCatherine Cabiling · contact · catherine.cabiling@bsci.com · 714-225-0903
ContactErum Shaikh · contact · Erum.Shaikh@bsci.com · 657-626-4310
InvestigatorGita Ghadimi, OD · study_director, Boston Scientific Corporation
All locations (20)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Urology AssociatesRecruiting
Fairhope, Alabama, United States
Mayo ClinicRecruiting
Scottsdale, Arizona, United States
El Camino HealthRecruiting
Mountain View, California, United States
Tri Valley UrologyRecruiting
Murrieta, California, United States
University of MiamiRecruiting
Miami, Florida, United States
Advanced Urology InstituteRecruiting
Oxford, Florida, United States
Louisiana State UniversityRecruiting
New Orleans, Louisiana, United States
WK Clinical ResearchRecruiting
Shreveport, Louisiana, United States
Anne Arundel UrologyRecruiting
Annapolis, Maryland, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Integrated Medical ProfessionalsRecruiting
New York, New York, United States
Associated Urologists of North Carolina (AUNC)Recruiting
Raleigh, North Carolina, United States
University Hospitals ClevelandRecruiting
Cleveland, Ohio, United States
Utica Park UrologyRecruiting
Tulsa, Oklahoma, United States
MidLantic UrologyRecruiting
Bala-Cynwyd, Pennsylvania, United States
Lowcountry Urology ClinicsRecruiting
North Charleston, South Carolina, United States
Urology Partners of North Texas (UPNT)Active Not Recruiting
Arlington, Texas, United States
Texas OncologyRecruiting
Houston, Texas, United States
Potomac UrologyRecruiting
Woodbridge, Virginia, United States