Hyivy Device in Endometriosis

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effect of using the Hyivy device on overall self-reported pelvic pain in people with endometriosis

Detailed Description
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Prior to study enrollment, all prospective participants will have the ability to contact the study team to learn more about the study and be provided with the relevant study-specific information. After being informed about the study and potential risks, all participants giving written informed consent will be assessed for their eligibility for the study, and enrolled participants will undergo a maximum 30-day screening period. On Day 0, eligible participants will start a 12-week use of Hyivy device with one visit on Week 6-7 and another on Week 12. After completing the 12-week intervention period, a virtual follow-up will be conducted on Week 16.

Official Title
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Evaluation of the Hyivy Device as a Non-hormonal Therapy in People With Endometriosis

Conditions
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Endometriosis, Pelvic Pain

Intervention / Treatment
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* Device: Hyivy device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective observational single-arm pre/post repeated-measures pilot intervention study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyivy Device<br>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 | Device: Hyivy device<br>* Intravaginal use of Hyivy device three times per week for 12 weeks, with each use session consisting of: 10 minutes of heat (37-42ºC) and 10 minutes of dilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall self-reported pelvic pain | Change in overall pelvic pain will be evaluated using a digital visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| site-specific tenderness and pelvic floor muscle pain | site-specific tenderness and pelvic floor muscle pain will be measured by Biberoglu and Behrman scale (B&B) ranging from 0 (none) to 15 (severe) | 12 weeks | 
| changes in quality of life | changes in quality of life as assessed by the Endometriosis Health Profile-30 (EHP-30) ranging from 0 (best possible health status) to 100 (worst possible health status) | 12 weeks | 
| sexual function | changes in sexual function as assessed by the Female Sexual Function Index (FSFI). The female sexual function index (FSFI) is a measure of sexual functioning in women. Scores range from 2 to 36 with higher scores indicating greater functioning. | 12 weeks | 
| changes in the use of rescue medications and Emergency rooms visits | changes in the use of rescue medications and Emergency rooms visits as assessed by a study-specific questionnaire | 12 weeks | 
| changes in peripheral inflammation | changes in Peripheral Inflammatory Protein Expression as assessed by an inflammatory multiplexed protein biomarker assay(a protein biomarker panel) from blood draw | 12 weeks | 
| feasibility of the Hyivy device | feasibility of the Hyivy device as a non-hormonal therapy in people with endometriosis as evaluated by review of participant subjective questionnaires(such as device size, easy to insert, hold and remove). | 12 weeks | 
| safety and tolerability of the Hyivy device assessed by the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0) | safety and tolerability of the Hyivy device as a non-hormonal therapy in people with endometriosis as assessed by review of adverse events (AE) and serious adverse events (SAE). | 12 weeks | 
| The adherence of the Hyivy device assessed by participants' compliance | adherence to the study regimen as assessed by comparing usage data collected by the Hyivy device to the recommended intervention regimen(adherence rate = # of times of patients did dilation therapy/# of times of patients should do dilation therapy *100%) | 12 weeks | 
| The usability and satisfaction of the Hyivy device | The usability and satisfaction of the Hyivy device for Hyivy's product development as assessed by study-specific questionnaires ranging from 11 (worst usability and satisfaction) to 55 (best usability and satisfaction) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Pelvic Pain, Dilator