Open
Actively Recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
About
Brief Summary
Prospective, multicenter, single-arm study
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
- Male subjects aged ≥ 22 years old
- Able to read, comprehend and willing to sign an informed consent form
- Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator
- Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator
Key Exclusion Criteria:
- Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent
- Poor candidate for surgical procedures and/or anesthesia, as determined by investigator
- Currently implanted with an Active Implantable Medical Device (AIMD)
- Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator
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Study Stats
Protocol No.
25-1875
Category
Autoimmune Disorders
Genitourinary Disorders
Principal Investigator
Contact
- Safia Khan
Location
- UCLA Westwood