Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II
FemPulse Corporation
Summary
A study to evaluate the safety and effectiveness of FemPulse System
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Key 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 systemi…
Interventions
- DeviceDevice Group
non-implanted, vaginal electrical stimulation device
- DrugMedication Group
OAB Medication
Locations (15)
- Cedars SinaiBeverly Hills, California
- UCLALos Angeles, California
- UC IrvineOrange, California
- StanfordPalo Alto, California
- USCDSan Diego, California
- Holy Cross Medical Group - Women's CenterFort Lauderdale, Florida