Status:
UNKNOWN
FemPulse Therapy for Overactive Bladder in Women
Lead Sponsor:
FemPulse Corporation
Conditions:
Urinary Bladder, Overactive
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
Detailed Description
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the sym...
Eligibility Criteria
Inclusion
- Females 21 years or older with a diagnosis of Overactive Bladder
- If of reproductive age, must use a reliable form of contraception
Exclusion
- Pregnant, was recently pregnant or is trying to conceive
- Has a metal pelvic implant or any electrically active implanted medical device
- Had a previous hysterectomy, pelvic radiation or pelvic cancer
- Has significant pelvic organ prolapse
- Had bladder treatment with onabotulinumtoxinA in the previous 12 months
- Has a significant heart condition
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03784170
Start Date
December 11 2018
End Date
December 1 2019
Last Update
November 8 2019
Active Locations (3)
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1
Minnesota Urology
Woodbury, Minnesota, United States, 55125
2
McKay Urology
Charlotte, North Carolina, United States, 28207
3
University of Washington Medical Center
Seattle, Washington, United States, 98195