Hyivy Device As Non-hormonal Therapy in Endometriosis

Not Applicable

Not yet recruiting

• Conditions: Pelvic Pain; Endometriosis
• Interventions: Device: Hyivy Intravaginal Device

• Registration Number: NCT05643131
• Lead Sponsor: Hyivy Health Inc

Brief Summary

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.

Detailed Description

Endometriosis is a chronic, inflammatory, estrogen-dependent disease characterized by ectopic growth of uterine-like cells outside the uterus. People living with endometriosis typically experience debilitating pelvic pain (dysmenorrhea, dyspareunia, dyschezia, dysuria, non-menstrual pelvic pain), and infertility. Endometriosis also has significant negative impacts on quality of life, physical, mental, and social wellbeing.

There is no diagnostic marker nor cure for this chronic disease. Current treatment options include medical therapies (mainly hormonal treatments aimed at suppressing menstruation or growth of the ectopic cells), surgery (to remove endometriotic lesions/nodules), and complementary or alternative therapies (non-medical or surgical options to manage symptoms; heat, mindfulness, diet, yoga, natural remedies, physical therapies, etc.).

Many people living with endometriosis report having used self-management strategies (complementary and alternative therapies) to manage their symptoms, and research on treatments and alternative therapies are consistently ranked among the top endometriosis research priorities. Alternative therapies have the potential to complement existing medical and surgical therapies, offering additional options to manage symptoms like pain.

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Study Start: 2025-04
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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, including hormonal therapies for any medical condition, and complimentary and/or alternative management of surgery for endometriosis and associated chronic pain
• 8.Agrees not to undergo pelvic physiotherapy with a trained professional during the study
• 9.Agrees to avoid taking non-steroidal anti-inflammatory drugs (e.g., ibuprofen) for 72 hours before Visits 1, 2, and 3
• 10.Must have the ability to charge the investigational device
• 11.Must be willing and able to insert intravaginal device
• 12.Able to understand, comply and consent to protocol requirements and instructions
• 13.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.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
• 5.Allergy to Hyivy device's materials
• 6.Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs) or infection in the pelvic area
• 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
• 10.Have open wounds, cuts, or open sores present in vaginal or pelvic area
• 11.Severe atrophic vaginitis or very dry, itchy, or sore vagina/vaginal area, at the discretion of the primary investigator(s)
• 12.Hypoesthesia or loss in sensation of the pelvic floor
• 13.Total and/or partial prolapse of the uterus and/or vagina
• 14.Symptoms of severe urinary retention, severe extra-urethral incontinence or overflow incontinence
• 15.Unable to position the device according to directions for use
• 16.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyivy Intravaginal Device	Hyivy Intravaginal Device	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.

Primary Outcome Measures

Name	Time	Method
Overall self-reported pelvic pain	Baseline, 6-weeks, 12-weeks	Overall pelvic pain will be evaluated using a digital visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Sexual Function (FSFI)	Baseline, 6-weeks, 12-weeks	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.
Feasibility of the Hyivy device	6-weeks, 12-weeks	Device usage will be assessed with a study-specific questionnaire.
Site-specific tenderness and pelvic floor muscle pain	Baseline, 6-weeks, 12-weeks	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
Adherence to study protocol	6-weeks, 12-weeks	Usage data collected by the Hyivy device will be used to assess participant adherence to the study regimen of 3 times/week device use.
Use of rescue medication	Baseline, 6-weeks, 12-weeks	Changes in the use of rescue medications for chronic pelvic pain, assessed with a study-specific questionnaire.
Quality of Life (EHP-30)	Baseline, 6-weeks, 12-weeks	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).
Safety and tolerability of the Hyivy device	Up to 12-weeks	Occurrence of adverse events (AE) and serious adverse events (SAE).

Trial Locations

Locations (1)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada