RecruitingNot ApplicableNCT06511141
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
Sacral Neuromodulation for Male Overactive Bladder
Sponsor
Axonics, Inc.
Enrollment
150 participants
Start Date
Oct 22, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria4
- 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
Exclusion Criteria10
- 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
Interventions
DEVICEAxonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Locations(19)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06511141
Related Trials
Mechanisms of Resistance to PSMA Radioligand Therapy
NCT054354953 locations
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
NCT0697084728 locations
Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
NCT0489583916 locations
INSIGHT-PCa: MRI- and PHI-Guided Risk-Adapted Strategy for Prostate Cancer Diagnosis
NCT073986901 location
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
NCT020646731 location