RecruitingNot ApplicableNCT07195656
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II
Sponsor
FemPulse Corporation
Enrollment
151 participants
Start Date
Sep 30, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A study to evaluate the safety and effectiveness of FemPulse System
Eligibility
Sex: FEMALEMin Age: 21 Years
Inclusion Criteria2
- 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).
Exclusion Criteria2
- 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.
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Interventions
DEVICEDevice Group
non-implanted, vaginal electrical stimulation device
DRUGMedication Group
OAB Medication
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT07195656
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