Hyivy Device in Endometriosis (endometriosis)
Endometriosis, Pelvic Pain
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Pelvic Pain, Dilator
Eligibility Criteria
Inclusion Criteria: 1.Age ≥ 18 at the time of enrollment 2.Generally in good health (other than due to endometriosis), at physician's discretion 3.Diagnosed with endometriosis (clinical, radiologic, or surgical) 4.Diagnosed with chronic pelvic pain (self-reported pain in pelvic area lasting >3 months) 5.VAS for overall pelvic pain ≥ 4 at screening and baseline 6.Medically managing endometriosis using continuous hormonal medications (i.e., oral contraceptive pills, progesterone only pills, Mirena, GnRH agonists/antagonists) for at least 3 months prior to enrollment 7.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period 8.Agrees not to undergo pelvic physiotherapy with a trained professional during the study 9.Must have the ability to charge the investigational device 10.Must be willing and able to insert intravaginal device 11.Able to understand, comply and consent to protocol requirements and instructions 12.Able to attend scheduled study visits and complete required investigations Exclusion Criteria: 1.Chronic pelvic pain thought to be due to a condition other than endometriosis 2.Diagnosis of premature ovarian insufficiency 3.Has a condition rendering them unable to understand the nature, scope and possible consequences of the study, or evidence of an uncooperative attitude 4.Any surgery in the past 3 months or anticipates having surgery during the study 5.Allergy to Hyivy device's materials 6.Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs) 7.Current use of antibiotics and a history of vulvovaginal candidiasis 8.Pregnant or lactating 9.Currently under the care of a pelvic floor physiotherapist Pre-study washout: If potential study participants are pregnant, lactating, or initiating hormonal contraceptives, their eligibility to participate in the study can be re-evaluated after 3 months of hormonal contraceptive use prior to enrollment. If potential study participants have an active vaginal infection or are currently using antibiotics with a history of vulvovaginal candidiasis, their eligibility to participate in the study can be re-evaluated after treatment, and resolution of the infection.
Sites / Locations
- McMaster University Medical Centre
Arms of the Study
Arm 1
Experimental
Hyivy Device
Participants will receive a Hyivy device with both verbal and written instructions. Recommended use is three times per week for 12 weeks and consists of: 10 minutes of heat (37-42ºC) per session and 10 minutes of dilation per session