Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)

a study on Overactive Bladder

Summary

Eligibility
for females ages 21 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
study ends around
Principal Investigator
by A Lenore Ackerman, MD (ucla)Olivia Chang, MD (uci)

Description

Summary

A study to evaluate the safety and effectiveness of FemPulse System

Official Title

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II

Keywords

Overactive Bladder (OAB), neuromodulation, Overactive Urinary Bladder, Device Group, Medication Group

Eligibility

You can join if…

Open to females ages 21 years and up

  • 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).

You CAN'T join if...

  • 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.

Locations

  • UCLA not yet accepting patients
    Los Angeles California 90095 United States
  • UC Irvine accepting new patients
    Orange California 92868 United States
  • USCD not yet accepting patients
    San Diego California 92037 United States
  • Cedars Sinai accepting new patients
    Beverly Hills California 90211 United States
  • Stanford accepting new patients
    Palo Alto California 94304 United States

Lead Scientists at University of California Health

  • A Lenore Ackerman, MD (ucla)
    Associate Professor, Urology, Medicine. Authored (or co-authored) 59 research publications
  • Olivia Chang, MD (uci)
    Associate Clinical Professor, Urology, School of Medicine. Authored (or co-authored) 82 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
FemPulse Corporation
ID
NCT07195656
Study Type
Interventional
Participants
Expecting 151 study participants
Last Updated
Contact us about this trial