RecruitingNot applicable

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Sacral Neuromodulation for Male Overactive Bladder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how well the Axonics SNM System works for men with overactive bladder after the device is on the market. The system uses nerve stimulation to help treat bladder symptoms. It is for men age 18 or older who leak urine with a sudden need to pee or pee often.

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older when joining.
  • Be able to keep bladder diaries and fill out study forms.
  • Have overactive bladder as your main diagnosis, with sudden urges that cause leaks or frequent peeing.
  • Be willing and able to give written consent and attend all study visits and follow-up checks for up to 1 year.

Who can't join

  • The study doctor thinks you are not a suitable candidate, or a major health problem could affect study tests, device use, or results.
  • You had prostate treatment or a prostate procedure in the past 6 months.
  • You have a brain, spinal cord, or nerve condition that could affect bladder function, such as stroke, seizures, multiple sclerosis, Parkinson’s disease, or major nerve damage.
  • You have had an implanted sacral nerve stimulation device, even if it is no longer active, or an implanted tibial nerve stimulation device that stimulates a nerve in the leg.
  • Tibial nerve stimulation through the skin helped your symptoms in the past 3 months.
  • You tried an external sacral nerve stimulation device, and a doctor found that it did not help.
  • You have diabetes that is not controlled.
  • You have a known allergy to device materials, including titanium, zirconia, polyurethane, epoxy, or silicone.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (23)

AL

AZ

  • Mayo Clinic · Scottsdale, AZ 85259Sirena Castillo · Study contactChristopher Wolter, MD · Principal investigatorMore trials in Scottsdale

CA

  • USNC · Mountain View, CA 94040Annette West · Study contactEdward Karpman, MD · Principal investigatorMore trials in Mountain View
  • Tri Valley Urology · Murrieta, CA 92562Kristi Dalton · Study contactAnita Deeds · Study contactVarun Talanki, MD · Principal investigatorMore trials in Murrieta
  • University of California San Francisco · San Francisco, CA 94143Natalie Rios · Study contactJennette Sison · Study contactMichelle Van Kuiken, MD · Principal investigatorMore trials in San Francisco

FL

  • University of Miami · Miami, FL 33136Maria N Odrosgoitia · Study contactElena Cortizas · Study contactRaveen Syan, MD · Principal investigatorMore trials in Miami
  • AdventHealth · Orlando, FL 32825Genevieve Rexford · Study contactDaniel S. Hoffman, MD · Principal investigatorMore trials in Orlando
  • Advanced Urology Institute · Oxford, FL 34481Josi Cortese · Study contactCaitlyn Gall · Study contactHarvey Taub, MD · Principal investigatorMore trials in Oxford

LA

  • Louisiana State University · New Orleans, LA 70112Jaya Mishra, PhD · Study contactRyan Krlin, MD · Principal investigatorMore trials in New Orleans
  • WK Clinical Research · Shreveport, LA 71103Patricia Johnson · Study contactSherry Stephens · Study contactGerard Henry, MD · Principal investigatorMore trials in Shreveport

MD

  • Anne Arundel Urology · Annapolis, MD 21401Megan Lormore · Study contactMara Holton, MD · Principal investigatorKari Bailey, MD · Sub-investigatorMore trials in Annapolis

MI

  • Wayne State University · Detroit, MI 48201Matthew Kronick · Study contactAron Liaw, MD · Principal investigatorMore trials in Detroit

MN

  • Mayo Clinic · Rochester, MN 55905Carter Day · Study contactMiranda Smith · Study contactMeghan Cooper, DO · Principal investigatorMore trials in Rochester

NC

  • Associated Urologists of North Carolina (AUNC) · Raleigh, NC 27612Kiplyne Moffett, RN · Study contactMark Jalkut, MD · Principal investigatorJohn Kaspar, MD · Sub-investigatorMore trials in Raleigh

NY

  • Integrated Medical Professionals · New York, NY 10016Michael Yang · Study contactLuis Leanez · Study contactJed Kaminetsky, MD · Principal investigatorThomas Rechtschaffen, MD · Sub-investigatorMore trials in New York

OH

  • University Hospitals Cleveland · Cleveland, OH 44106Twishasri Dasgupta · Study contactAram Loeb, MD · Principal investigatorMore trials in Cleveland

OK

  • Utica Park Urology · Tulsa, OK 74104Alex Heinze, PA-C · Study contactMelanie Ketchandji, MD · Principal investigatorMore trials in Tulsa

PA

  • MidLantic Urology · Bala-Cynwyd, PA 19004Cheryl Zinar · Study contactKelly Liberatore · Study contactLaurence Belkoff, DO · Principal investigatorMore trials in Bala-Cynwyd

SC

  • Lowcountry Urology Clinics · North Charleston, SC 29406Josi Cortese · Study contactJustin Ellett, MD · Principal investigatorMore trials in North Charleston

TX

  • Urology Partners of North Texas (UPNT) · Arlington, TX 76017Grace Yoon · Study contactMichelle Le · Study contactGeoffrey Nuss, MD · Principal investigatorMore trials in Arlington
  • Texas Oncology · Houston, TX 77070More trials in Houston

VA

  • Potomac Urology · Woodbridge, VA 22191Annelise Marsh · Study contactAlok Desai, MD · Principal investigatorMore trials in Woodbridge