FemPulse Therapy for Overactive Bladder in Women
| Status: | Recruiting |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/16/2019 |
| Start Date: | December 11, 2018 |
| End Date: | April 2019 |
| Contact: | Robert Kieval |
| Email: | rkieval@fempulse.com |
Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder
The purpose of this clinical trial is to investigate a new medical device treatment for
Overactive Bladder (OAB) in women.
Overactive Bladder (OAB) in women.
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 symptoms of OAB.
nerves that regulate bladder function. It is believed that stimulation of these nerves may
help relieve the symptoms of OAB.
Inclusion Criteria:
- Females 21 years or older with a diagnosis of Overactive Bladder
- If of reproductive age, must use a reliable form of contraception
Exclusion Criteria:
- 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
We found this trial at
3
sites
Woodbury, Minnesota 55125
Principal Investigator: Steven Siegel, MD
Phone: 651-999-7032
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Charlotte, North Carolina 28207
Principal Investigator: Michael Kennelly, MD
Phone: 704-355-7466
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1959 NE Pacific St
Seattle, Washington 98195
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Suzette Sutherland, MD
Phone: 206-616-8723
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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