Usability Study of the FemPulse System

Launched by FEMPULSE CORPORATION · Mar 29, 2024

Keywords

ClinConnect Summary

The FemPulse System Study is looking at how easy it is for women with overactive bladder (OAB) to use a new device designed to help manage their symptoms. This study is currently recruiting participants who are female, at least 21 years old, and have been diagnosed with OAB for over six months. To be eligible, participants need to be able to read and understand instructions, follow study guidelines, and comfortably operate the FemPulse System and its mobile app.

If you join the study, you’ll be asked to maintain your current medication routine, keep track of your fluid intake, and fill out a diary about your experiences. It’s important to know that women who are pregnant, planning to become pregnant, or starting new OAB treatments during the study won't be eligible. This study aims to ensure that the FemPulse System can be used safely and effectively, helping women like you manage OAB better.

Gender

FEMALE

Eligibility criteria

• 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.