04 Mar Usability Study
This study will evaluate a new medical device that has been developed to treat Overactive Bladder, or OAB, a condition characterized by the need to urinate urgently and/or frequently often accompanied by the leakage of urine. The device consists of a flexible silicone rubber ring with small electrodes on it. It is worn within the vagina, near the cervix, and it delivers mild electrical stimulation to nearby nerves to potentially improve bladder function. While you might feel a brief, mild sensation from this stimulation during testing in the clinic, generally you should not be aware of the stimulation or feel any discomfort. The study will be conducted over a total of 28 days, including a period of about 21 days during which you would wear the device continuously. The study is designed to have minimal impact on your normal daily routine. You would also visit our clinic 5 times, about once a week over the 28 days. Each visit would take 1 to 2 hours. The study is designed to include 20 participants.
This new medical device has not yet been approved by the FDA, so it is referred to as an investigational device. The study has been approved as a type of study called a Non-significant Risk study. That means that the study is expected to pose very little health risk to people who participate in it. Before you join the study you would be provided with information that describes the study in more detail and explains any health risks that could be involved. You’d also be able to ask any questions about the study that you have before deciding whether or not to participate. You may take as much time as you want to decide, you wouldn’t need to decide on the spot or even on that day.
Participant Eligibility
1. Have a strong, sudden urge to urinate or urinate frequently.
2. Have a diagnosis of overactive bladder (OAB) for greater than 6 months
3. 21 years old or older
4. Not pregnant or been pregnant in the past year
5. No implanted medical devices
6.No history of pelvic cancer
Contact
Katie Wicklander
(206) 258-9014
Additional Study Details
Full Study Title
Usability Study of the FemPulse System
Investigator(s)
Dr. Jane Miller
Accepts Healthy Volunteers?
No
Study Site(s)
University of Washington Medical Pelvic Health Center, McMurray Building 3rd floor, Northwest Hospital Campus
1550 N 115th St. 3rd floor
Seattle, Washington 98133
University of Washington, Mountlake Campus
1959 NE Pacific St.
Seattle Washington 98195
