Axonics SNM System
DeviceTo assess clinical outcomes of the Axonics SNM System in the male OAB population.
NCT Number: NCT06511141
To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
University of Alabama at Birmingham, Birmingham, Alabama, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
To assess clinical outcomes of the Axonics SNM System in the male OAB population.
Time frame: 6 months, 1 year
Device related, procedure-related and all serious adverse events
Time frame: 6 months, 1 year
Demonstrate a ≥ 50% reduction in the number of UUI or UF episodes on a 3-day diary
Time frame: 6 months, 1 year
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.
Contact information is provided by the study sponsor or research team.
Catherine Cabiling
CONTACT
Erum Shaikh
CONTACT
Axonics, Inc.
Industry
Sacral Neuromodulation for Male Overactive Bladder
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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