About this trial
A study to evaluate the safety and effectiveness of FemPulse System
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Device Group
- Medication Group
Treatment groups
Sponsors and collaborators
FemPulse Corporation
Lead sponsor
Moxie Clinical
Collaborator