Hyivy Device as Non-hormonal Therapy in Endometriosis

ConditionsEndometriosis Pelvic Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorHyivy Health Inc

About this trial

This study seeks to address accessible management of endometriosis-associated chronic pelvic pain by evaluating a novel device used in the home. The study is designed as a proof-of-concept single-arm pilot study, and the primary objective is to assess change in overall self-reported pelvic pain in people with endometriosis-associated chronic pelvic pain following the use of the Hyivy intravaginal device.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

1.Chronic pelvic pain thought to be due to a condition other than endometriosis

2.Diagnosis of premature ovarian insufficiency

3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)

4.Any surgery in the past 3 months or anticipates having surgery during the study

Trial design

Design model

Single group

Treatments tested in this trial

Hyivy Intravaginal Device
Device
Intravaginal use of Hyivy device three times per week for 12 weeks, with each session consisting of 10 minutes of heat (37-39ºC) and 10 minutes of dilation.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Hyivy Intravaginal DeviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Overall self-reported pelvic pain

Overall pelvic pain will be evaluated using a digital visual analog scale (VAS)

Time frame

Baseline, 6-weeks, 12-weeks

Secondary outcomes

Site-specific tenderness and pelvic floor muscle pain

Site-specific tenderness and pelvic floor muscle pain will be measured by the Biberoglu and Behrman scale (B\&B) ranging from 0 (none) to 15 (severe) and patient exams

Time frame

Baseline, 6-weeks, 12-weeks

Quality of Life (EHP-30)

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).

Time frame

Baseline, 6-weeks, 12-weeks

Sexual Function (FSFI)

Changes in sexual function as assessed by the Female Sexual Function Index (FSFI). Scores range from 2 to 36 with higher scores indicating greater functioning.

Time frame

Baseline, 6-weeks, 12-weeks

Safety and tolerability of the Hyivy device

Occurrence of adverse events (AE) and serious adverse events (SAE).

Time frame

Up to 12-weeks

Other outcomes

Autonomic function

Autonomic nervous system (ANS) function will be assessed using measures of heart rate variability (HRV) during a deep breathing test, active standing test, and water intake test.

Time frame

Baseline, 6-weeks, 12-weeks

Peripheral gene expression

Changes in peripheral inflammation as assessed by a protein biomarker panel before and after device use

Time frame

Baseline, 6-weeks, 12-weeks

Emergency room (ER) visits

Number of ER visits due to chronic pelvic pain in the last 6 weeks

Time frame

Baseline, 6-weeks, 12-weeks

Device usability and patient satisfaction

Study-specific questionnaire to gather patient feedback

Time frame

12-weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hyivy Health Inc

Lead sponsor

McMaster University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: