Open
Actively Recruiting
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
About
Brief Summary
A study to evaluate the safety and effectiveness of FemPulse System
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
- Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms
- Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
Key Exclusion Criteria:
- Systemic condition or disease that may interfere with study participation (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) as determined by study investigator.
- Not an appropriate study candidate as determined by investigator.
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Study Stats
Protocol No.
25-0888
Category
Genitourinary Disorders
Principal Investigator
Lenny Ackerman
Contact
- Katelyn Levitt
Location
- UCLA Westwood