Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Korábbi kezelés

• Recent prostate therapy or procedure within the last 6 months at the time of enrollment
• Previously implanted with a sacral neuromodulation device, including inactive SNM devices
• Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)

Más betegség

• 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)
• 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

Egyéb

• Any patient that is not a suitable candidate per investigator discretion
• 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

• 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