Sacral Neuromodulation for Male Overactive Bladder (MOAB)
- Conditions
- ProstatectomyOveractive BladderBenign Prostatic HyperplasiaProstate CancerUrinary Urgency Incontinence
- Interventions
- Device: Axonics SNM System
- Registration Number
- NCT06511141
- Lead Sponsor
- Axonics, Inc.
- Brief Summary
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 150
- Participants aged ≥ 18 years at the time of enrollment
- Able to complete bladder diaries and patient questionnaires
- Primary diagnosis of Urinary Urgency Incontinence (UUI)
- 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
- Underwent prostatectomy for prostate cancer at least 6 months prior to enrollment
- Underwent radiation therapy for prostate cancer at least 6 months prior to enrollment
- Underwent cytoreductive surgical intervention for BPH at least 6 months prior to enrollment
Key
- 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)
- 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 (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain)
- Uncontrolled diabetes
- Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Axonics SNM System Clinical outcomes with use of Axonics SNM system for the male OAB population.
- Primary Outcome Measures
Name Time Method Performance/Effectiveness - Improvement in Qualify of Life scoring 6 months, 1 year International Consultation of Incontinence Questionnaire Overactive Bladder Qualify 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.
Adverse event reporting (Safety) 6 months, 1 year Device related, procedure-related and all serious adverse events
Performance/Effectiveness - Reduction in UUI episodes 6 months, 1 year Demonstrate a ≥ 50% reduction in the number of UUI episodes on a 3-day diary
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University Hospitals Cleveland
🇺🇸Cleveland, Ohio, United States
Urology Partners of North Texas (UPNT)
🇺🇸Arlington, Texas, United States
El Camino Health
🇺🇸Mountain View, California, United States
WK Clinical Research
🇺🇸Shreveport, Louisiana, United States
Potomac Urology
🇺🇸Woodbridge, Virginia, United States