Usability Study of the FemPulse System
Not Applicable
Recruiting
- Conditions
- Overactive Bladder
- Registration Number
- NCT06347380
- Lead Sponsor
- FemPulse Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Patient Satisfaction 28 days Proportion of subjects reporting satisfaction with the use of the FemPulse System
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Holy Cross Women's Hospital
🇺🇸Fort Lauderdale, Florida, United States
Univ. of Washington
🇺🇸Seattle, Washington, United States
Holy Cross Women's Hospital🇺🇸Fort Lauderdale, Florida, United StatesIsha KhanContactIsha Khan <Isha.Khan@holy-cross.com>