Status:
RECRUITING
Ease of Use Study of the FemPulse System
Lead Sponsor:
FemPulse Corporation
Conditions:
Overactive Bladder (OAB)
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
The objective of the study is to demonstrate that the FemPulse System can be used as indicated
Detailed Description
The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Patient and Clinician Instructions for Use (IFU), as applicable.
Eligibility Criteria
Inclusion
- Key
- Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, 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 .
- Able to read, comprehend, and reliably provide informed consent and study-related information.
- Willing and able to comply with study required procedures and visits
Exclusion
- Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol.
- Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator.
- 4\. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.
Key Trial Info
Start Date :
February 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06885099
Start Date
February 11 2025
End Date
August 31 2025
Last Update
March 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Holy Cross Women's Hospital
Fort Lauderdale, Florida, United States, 33334