Overactive Bladder (OAB)
Conditions
Keywords
neuromodulation
Brief summary
A study to evaluate the safety and effectiveness of FemPulse System
Interventions
DEVICEDevice Group
non-implanted, vaginal electrical stimulation device
DRUGMedication Group
OAB Medication
Sponsors
FemPulse Corporation
Moxie Clinical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Voids per Day | 6 months | Difference in mean change between device and medication groups in number of voids per day (VPD) |
Countries
United States
Contacts
CONTACTMonica Unger
PRINCIPAL_INVESTIGATORSuzette Sutherland, MD
FemPulse Corporation
Outcome results
None listed