Status:
COMPLETED
FemPulse Therapy First-in-Human Experience
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 in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may...
Eligibility Criteria
Inclusion
- Females ≥21 yrs with Overactive Bladder
Exclusion
- Is or was recently pregnant
- Has a metal pelvic implant or any electrically active implanted medical device
- Has a urinary tract or vaginal infection
- Had a previous hysterectomy, pelvic radiation or pelvic cancer
- Has significant pelvic organ prolapse
- Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
- Has a significant heart condition or a history of vasovagal reaction or low blood pressure
Key Trial Info
Start Date :
February 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03874637
Start Date
February 14 2017
End Date
May 17 2017
Last Update
March 14 2019
Active Locations (2)
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1
Minnesota Urology
Woodbury, Minnesota, United States, 55125
2
University of Washington Medical Center
Seattle, Washington, United States, 98195