- Recruiting
- Treatment
- Interventional
- Device
- Axonics, Inc.
- 18 - 75 Years
Study Purpose
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Intervention
Device : Axonics SNM System
Eligibility Requirements
Participants aged ≥ 18 years at the time of enrollment
Able to complete bladder diaries and patient questionnaires
Primary diagnosis of Urinary Urgency Incontinence (UUI)
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
Underwent prostatectomy for prostate cancer at least 6 months prior to enrollment
Underwent radiation therapy for prostate cancer at least 6 months prior to enrollment
Underwent cytoreductive surgical intervention for BPH at least 6 months prior to enrollment
Minimum age: 18
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 (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain)
Uncontrolled diabetes
Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
Recruiting status
Recruiting
Estimated enrollment
120
Study start date
Oct 01, 2024
Study end date
Mar 31, 2027
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Device
Study phase
NA
Allocation
Na
Sponsor:
Axonics, Inc.
Collaborator:
N/A
Investigator:
Karen Noblett, MD
Publications
N/A
Websites
N/A
NCT06511141
Clinic | Location | Investigator | Distance | RECRUITING STATUS | Contact |
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