FemPulse Therapy First-in-Human Experience
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/16/2019 |
| Start Date: | February 14, 2017 |
| End Date: | May 17, 2017 |
Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB
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 in the lower abdomen that regulate bladder function. It is believed that stimulation
of these nerves may help relieve the symptoms of OAB.
nerves in the lower abdomen that regulate bladder function. It is believed that stimulation
of these nerves may help relieve the symptoms of OAB.
Inclusion Criteria:
- Females ≥21 yrs with Overactive Bladder
Exclusion Criteria:
- 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
We found this trial at
2
sites
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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