Status:
NOT_YET_RECRUITING
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
Lead Sponsor:
FemPulse Corporation
Conditions:
Overactive Bladder (OAB)
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
A study to evaluate the safety and effectiveness of FemPulse System
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT07195656
Start Date
September 30 2025
End Date
May 31 2028
Last Update
September 29 2025
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