Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II

A study to evaluate the safety and effectiveness of FemPulse System

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.