NCT06511141 Sacral Neuromodulation for Male Overactive Bladder (MOAB)
| NCT ID | NCT06511141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Axonics, Inc. |
| Condition | Overactive Bladder |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-10-22 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
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
Contact & Investigator
Gita Ghadimi, OD
STUDY DIRECTOR
Boston Scientific Corporation
Frequently Asked Questions
Who can join the NCT06511141 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Overactive Bladder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06511141 currently recruiting?
Yes, NCT06511141 is actively recruiting participants. Contact the research team at catherine.cabiling@bsci.com for enrollment information.
Where is the NCT06511141 trial being conducted?
This trial is being conducted at Birmingham, United States, Fairhope, United States, Scottsdale, United States, Mountain View, United States and 11 additional locations.
Who is sponsoring the NCT06511141 clinical trial?
NCT06511141 is sponsored by Axonics, Inc.. The principal investigator is Gita Ghadimi, OD at Boston Scientific Corporation. The trial plans to enroll 150 participants.