Overview

The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable.

Eligibility

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
• Able to read, comprehend, and reliably provide informed consent and study-related information.
• Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
• Has adequate cognitive and manual capabilities to operate the FemPulse System and other components (e.g., mobile app) as assessed by the investigator.

Key Exclusion Criteria:

• Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period.
• Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period.
• Not an appropriate study candidate as determined by investigator.