Clinical Trials in the USA / NCT07195656
Recruiting
Not applicable
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
NCT07195656 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Overactive Bladder (OAB)
Investigational drug(s) / intervention(s)
Device GroupMedication Group
Device Group: non-implanted, vaginal electrical stimulation device
Medication Group: OAB Medication
Study summary
A study to evaluate the safety and effectiveness of FemPulse System
Eligibility
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.
Primary outcome measure(s)
- Mean Change in Voids per Day — 6 months
Difference in mean change between device and medication groups in number of voids per day (VPD)
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars Sinai | Beverly Hills | California | Recruiting |
| UCLA | Los Angeles | California | Recruiting |
| UC Irvine | Orange | California | Recruiting |
| Stanford | Palo Alto | California | Recruiting |
| USCD | San Diego | California | Recruiting |
| Holy Cross Medical Group - Women's Center | Fort Lauderdale | Florida | Recruiting |
| Comprehensive Urologic | Barrington | Illinois | Recruiting |
| University of Louisville | Louisville | Kentucky | Not Yet Recruiting |
| Chesapeake Urology | Owings Mills | Maryland | Recruiting |
| Minnesota Urology | Woodbury | Minnesota | Not Yet Recruiting |
| Adult & Pediatric Urology | Omaha | Nebraska | Recruiting |
| Atrium Health | Charlotte | North Carolina | Recruiting |
| Southern Urogynecology | West Columbia | South Carolina | Recruiting |
| Sanford Health | Sioux Falls | South Dakota | Recruiting |
| INOVA | Falls Church | Virginia | Not Yet Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07195656 on ClinicalTrials.gov ↗ ← All trials in the USA