RecruitingNot Applicable

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

United States150 participantsStarted 2024-10-22

Plain-language summary

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

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Adverse event reporting (Safety)

Timeframe: 6 months, 1 year

Performance/Effectiveness - Reduction in UUI or UF episodes

Timeframe: 6 months, 1 year

NCT IDNCT06511141

SponsorAxonics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Catherine Cabiling

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.