A study to evaluate the safety and effectiveness of FemPulse System
Eligibility
Sex
FEMALE
Min age
21 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Mean Change in Voids per Day — 6 months Difference in mean change between device and medication groups in number of voids per day (VPD)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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