Trial Summary
What is the purpose of this trial?This trial is testing the Hyivy device, which is designed to help reduce pelvic pain. The study focuses on people with endometriosis, a condition that causes significant pelvic pain. The device likely uses physical therapy methods to ease this pain.
Eligibility Criteria
This trial is for adults over 18 with endometriosis and chronic pelvic pain lasting more than 3 months. Participants must be in good health otherwise, have been managing endometriosis with hormones for at least 3 months, and be willing to use an intravaginal device. They can't start new treatments or physiotherapy during the study, nor have conditions like active infections or recent surgeries that could interfere.Inclusion Criteria
Must be willing and able to insert intravaginal device
I have been treating my endometriosis with hormones non-stop for 3 months.
Agrees not to commence any new treatments for the 12-week intervention period
+15 more
Exclusion Criteria
You are allergic to the materials used in the Hyivy device.
I do not have an active vaginal infection.
I am currently taking antibiotics and have had yeast infections before.
+6 more
Participant Groups
The Hyivy device is being tested to see if it reduces self-reported pelvic pain in individuals with endometriosis. The study involves participants using this intravaginal device regularly and monitoring their pain levels without starting any other new treatments.
1Treatment groups
Experimental Treatment
Group I: Hyivy Intravaginal DeviceExperimental Treatment1 Intervention
Participants will receive a Hyivy intravaginal device for at-home use. Recommended use is three times per week for 12 weeks and consists of 10 minutes of heat (37-39ºC) and 10 minutes of dilation per session.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
McMaster University Medical CentreHamilton, Canada
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Who Is Running the Clinical Trial?
Hyivy Health IncLead Sponsor
McMaster UniversityCollaborator