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NCT Number: NCT06511141

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

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

Recruiting

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Key information

About this study

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients who have a prior history of radical prostatectomy or radiation for prostate cancer or who have a history of cytoreductive surgical intervention for benign prostatic hyperplasia (BPH).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participants aged ≥ 18 years at the time of enrollment
  • Able to complete bladder diaries and patient questionnaires
  • Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).
  • 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:

  • 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)
  • Positive response to 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 at the discretion of the participating physician.
  • Uncontrolled diabetes
  • Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone

Treatment and study plan

Axonics SNM System

Device

To assess clinical outcomes of the Axonics SNM System in the male OAB population.

Primary outcomes

  1. Adverse event reporting (Safety)

    Time frame: 6 months, 1 year

    Device related, procedure-related and all serious adverse events

  2. Performance/Effectiveness - Reduction in UUI or UF episodes

    Time frame: 6 months, 1 year

    Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary

Secondary outcomes

  1. Performance/Effectiveness - Improvement in Quality of Life scoring

    Time frame: 6 months, 1 year

    International Consultation of Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Cabiling

CONTACT

[email protected]

714-225-0903

Erum Shaikh

CONTACT

[email protected]

657-626-4310

Sponsors and collaborators

Lead sponsor

Axonics, Inc.

Industry

Registry information

Official study title

Sacral Neuromodulation for Male Overactive Bladder

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 19, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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