Actively Recruiting
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II
Led by FemPulse Corporation · Updated on 2026-02-06
151
Participants Needed
15
Research Sites
30 weeks
Total Duration
On this page
Sponsors
F
FemPulse Corporation
Lead Sponsor
M
Moxie Clinical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the FemPulse System, a non-implanted electrical stimulation device, for women with overactive bladder (OAB). This condition includes symptoms like urinary urgency, frequent urination, and nighttime urination, with or without urgency urinary incontinence. The study is sponsored by FemPulse Corporation and compares this device to medication treatments for OAB. Participants will be randomly assigned to one of two groups. One group will use the FemPulse System, which delivers vaginal electrical stimulation without implantation. The other group will receive standard OAB medication. The study will assess the changes in the number of times participants urinate each day over a 6-month period. Women who join the study will need to follow study procedures such as consistent medication use, managing fluid intake, and completing diaries about their symptoms. Researchers will monitor their urinary patterns and safety throughout the study. The main outcome measured is the average change in daily voiding frequency after six months of treatment.
CONDITIONS
Brief Title
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with a uterus and cervix
- At least 21 years old
- Diagnosed with overactive bladder with symptoms lasting more than 6 months
- Willing and able to comply with study procedures including consistent medication use, fluid intake, and diary completion
You will not qualify if you...
- Having a systemic condition or disease that may interfere with study participation, such as current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, or history of myocardial infarction
- Determined not an appropriate study candidate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either a non-implanted vaginal electrical stimulation device or medication to treat overactive bladder symptoms.
Monthly visits during treatment
Trial Site Locations
Total: 15 locations
1
Cedars Sinai
Beverly Hills, California, United States, 90211
Actively Recruiting
2
UCLA
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
UC Irvine
Orange, California, United States, 92868
Actively Recruiting
4
Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
5
USCD
San Diego, California, United States, 92037
Not Yet Recruiting
6
Holy Cross Medical Group - Women's Center
Fort Lauderdale, Florida, United States, 33334
Not Yet Recruiting
7
Comprehensive Urologic
Barrington, Illinois, United States, 60010
Actively Recruiting
8
University of Louisville
Louisville, Kentucky, United States, 40205
Not Yet Recruiting
9
Chesapeake Urology
Owings Mills, Maryland, United States, 21117
Actively Recruiting
10
Minnesota Urology
Woodbury, Minnesota, United States, 55125
Not Yet Recruiting
11
Adult & Pediatric Urology
Omaha, Nebraska, United States, 68114
Actively Recruiting
12
Atrium Health
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
13
Southern Urogynecology
West Columbia, South Carolina, United States, 29169
Actively Recruiting
14
Sanford Health
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
15
INOVA
Falls Church, Virginia, United States, 22042
Not Yet Recruiting
Research Team
M
Monica Unger
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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