A study to evaluate the safety and effectiveness of FemPulse System
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).
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.
Parallel
Device Group
Devicenon-implanted, vaginal electrical stimulation device
Medication Group
DrugOAB Medication
Mean Change in Voids per Day
Difference in mean change between device and medication groups in number of voids per day (VPD)
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FemPulse Corporation
Lead sponsor
Moxie Clinical
Collaborator
