Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
Not Applicable
Not yet recruiting
- Conditions
- Overactive Bladder (OAB)
- Interventions
- Device: Device GroupDrug: Medication Group
- Registration Number
- NCT07195656
- Lead Sponsor
- FemPulse Corporation
- Brief Summary
A study to evaluate the safety and effectiveness of FemPulse System
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 151
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. 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device Group Device Group Subjects receiving the FemPulse System Medication Group Medication Group Subjects receiving medication
- Primary Outcome Measures
Name Time Method Mean Change in Voids per Day 6 months Difference in mean change between device and medication groups in number of voids per day (VPD)
- Secondary Outcome Measures
Name Time Method