Actively Recruiting
Sacral Neuromodulation for Male Overactive Bladder
Led by Axonics, Inc. · Updated on 2026-05-12
150
Participants Needed
20
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the outcomes of the Axonics Sacral Neuromodulation (SNM) System in treating overactive bladder (OAB) in male patients. This study focuses on men who have a history of radical prostatectomy or radiation treatment for prostate cancer, or who have undergone cytoreductive surgery for benign prostatic hyperplasia (BPH). The purpose is to assess how well the device works and its safety after market approval. Participants will receive the Axonics SNM System, a device designed to help regulate bladder function. The study includes men with different prior treatments, such as prostatectomy, radiation, or BPH surgery, all performed at least six months before enrolling. The device's clinical outcomes will be monitored over time to understand its effects on urinary symptoms. During the study, participants will complete bladder diaries and questionnaires to track their symptoms and quality of life. Researchers will monitor safety by reporting any adverse events at six months and one year, while also measuring reductions in urinary urgency incontinence and frequency episodes. Quality of life improvements will be assessed at the same intervals. Participants must attend follow-up visits for up to one year to provide data for these evaluations.
CONDITIONS
Brief Title
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 60 18 years at the time of enrollment
- Able to complete bladder diaries and patient questionnaires
- Primary diagnosis of overactive bladder with urinary urgency incontinence or urinary frequency
- Willing and capable to provide written informed consent and comply with study evaluations and follow-ups for up to 1 year
You will not qualify if you...
- Not a suitable candidate per investigator discretion
- Recent prostate therapy or procedure within the last 6 months
- Neurological conditions interfering with bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, peripheral neuropathy, or spinal cord injury
- Previously implanted with any sacral neuromodulation device
- Prior treatment with Implantable Tibial Nerve Stimulation (ITNS)
- Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months
- Underwent an external trial with sacral neuromodulation device and was a non-responder
- Significant medical condition interfering with study procedures or device operation
- Uncontrolled diabetes
- Known allergies to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants receive the Axonics SNM System implant to treat overactive bladder.
Follow-up visits over 1 year to monitor device performance and safety
Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Urology Associates
Fairhope, Alabama, United States, 36532
Active, Not Recruiting
3
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Actively Recruiting
4
El Camino Health
Mountain View, California, United States, 94040
Actively Recruiting
5
Tri Valley Urology
Murrieta, California, United States, 92562
Actively Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
7
Advanced Urology Institute
Oxford, Florida, United States, 34481
Actively Recruiting
8
Louisiana State University
New Orleans, Louisiana, United States, 70112
Actively Recruiting
9
WK Clinical Research
Shreveport, Louisiana, United States, 71103
Actively Recruiting
10
Anne Arundel Urology
Annapolis, Maryland, United States, 21401
Actively Recruiting
11
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
Integrated Medical Professionals
New York, New York, United States, 10016
Actively Recruiting
13
Associated Urologists of North Carolina (AUNC)
Raleigh, North Carolina, United States, 27612
Actively Recruiting
14
University Hospitals Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
15
Utica Park Urology
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
16
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
17
Lowcountry Urology Clinics
North Charleston, South Carolina, United States, 29406
Actively Recruiting
18
Urology Partners of North Texas (UPNT)
Arlington, Texas, United States, 76017
Active, Not Recruiting
19
Texas Oncology
Houston, Texas, United States, 77070
Completed
20
Potomac Urology
Woodbridge, Virginia, United States, 22191
Actively Recruiting
Research Team
C
Catherine Cabiling
E
Erum Shaikh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here