Sacral Neuromodulation for Male Overactive Bladder
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).
Arms & interventions
- DeviceAxonics SNM System
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Outcome measures
Primary
Adverse event reporting (Safety)
Device related, procedure-related and all serious adverse events
Time frame: 6 months, 1 year
Performance/Effectiveness - Reduction in UUI or UF episodes
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
Time frame: 6 months, 1 year
Secondary
Performance/Effectiveness - Improvement in Quality of Life scoring
Time frame: 6 months, 1 year
Eligibility criteria
Study locations (20)
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Urology Associates
Fairhope, Alabama, 36532
Mayo Clinic
Scottsdale, Arizona, 85259
El Camino Health
Mountain View, California, 94040
Tri Valley Urology
Murrieta, California, 92562
University of Miami
Miami, Florida, 33136
Advanced Urology Institute
Oxford, Florida, 34481
Louisiana State University
New Orleans, Louisiana, 70112
WK Clinical Research
Shreveport, Louisiana, 71103
Anne Arundel Urology
Annapolis, Maryland, 21401
Mayo Clinic
Rochester, Minnesota, 55905
Integrated Medical Professionals
New York, New York, 10016
Associated Urologists of North Carolina (AUNC)
Raleigh, North Carolina, 27612
University Hospitals Cleveland
Cleveland, Ohio, 44106
Utica Park Urology
Tulsa, Oklahoma, 74104
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
Lowcountry Urology Clinics
North Charleston, South Carolina, 29406
Urology Partners of North Texas (UPNT)
Arlington, Texas, 76017
Texas Oncology
Houston, Texas, 77070
Potomac Urology
Woodbridge, Virginia, 22191