Treatment for male overactive bladder using sacral neuromodulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• Usnc
  Mountain View, California, United States Recruiting
• Tri Valley Urology
  Murrieta, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Catherine Cabiling
• Email: catherine.cabiling@bsci.com
• Phone: 714-225-0903

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.