To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUrology Associates
Fairhope, Alabama, United States
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
Performance/Effectiveness - Improvement in Quality of Life scoring
International Consultation of Incontinence Questionnaire Overactive Bladder Quality 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.
Time frame: 6 months, 1 year
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El Camino Health
Mountain View, California, United States
RECRUITINGTri Valley Urology
Murrieta, California, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGLouisiana State University
New Orleans, Louisiana, United States
RECRUITINGWK Clinical Research
Shreveport, Louisiana, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGUniversity Hospitals Cleveland
Cleveland, Ohio, United States
RECRUITINGUtica Park Urology
Tulsa, Oklahoma, United States
RECRUITING...and 3 more locations