Treatment for male overactive bladder using sacral neuromodulation
Sacral Neuromodulation for Male Overactive Bladder
This study is testing a new device to see if it can help men with overactive bladder feel better after prostate surgery or radiation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Axonics, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 20 sites (Birmingham, Alabama and 19 other locations) |
| Trial ID | NCT06511141 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Axonics SNM System in treating overactive bladder in male patients who have previously undergone prostate surgery or radiation therapy. The study focuses on assessing clinical outcomes post-market for participants diagnosed with urinary urgency incontinence. Eligible patients will be monitored for up to one year, completing bladder diaries and questionnaires to track their progress. The trial aims to provide insights into the long-term benefits and safety of this neuromodulation approach.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with a history of prostatectomy or radiation therapy for prostate cancer, or cytoreductive surgery for benign prostatic hyperplasia.
Not a fit: Patients who have had recent prostate therapy or those with neurological conditions affecting bladder function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bladder control and quality of life for men suffering from overactive bladder.
How similar studies have performed: Previous studies on sacral neuromodulation have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 19 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Urology Associates — Fairhope, Alabama, United States (Active_not_recruiting)
- Mayo Clinic — Scottsdale, Arizona, United States (Recruiting)
- El Camino Health — Mountain View, California, United States (Recruiting)
- Tri Valley Urology — Murrieta, California, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Advanced Urology Institute — Oxford, Florida, United States (Recruiting)
- Louisiana State University — New Orleans, Louisiana, United States (Recruiting)
- WK Clinical Research — Shreveport, Louisiana, United States (Recruiting)
- Anne Arundel Urology — Annapolis, Maryland, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Integrated Medical Professionals — New York, New York, United States (Recruiting)
- Associated Urologists of North Carolina (AUNC) — Raleigh, North Carolina, United States (Recruiting)
- University Hospitals Cleveland — Cleveland, Ohio, United States (Recruiting)
- Utica Park Urology — Tulsa, Oklahoma, United States (Recruiting)
- MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States (Recruiting)
- Lowcountry Urology Clinics — North Charleston, South Carolina, United States (Recruiting)
- Urology Partners of North Texas (UPNT) — Arlington, Texas, United States (Active_not_recruiting)
- Texas Oncology — Houston, Texas, United States (Completed)
- Potomac Urology — Woodbridge, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Catherine Cabiling
- Email: catherine.cabiling@bsci.com
- Phone: 714-225-0903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.