Hyivy Device as Non-hormonal Therapy in Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometriosis Pelvic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective observational pre/post repeated-measures pilot intervention study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None (Open Label)

Study Groups

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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.

Group Type EXPERIMENTAL

Hyivy Intravaginal Device

Intervention Type 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.

Interventions

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Hyivy Intravaginal 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.

Intervention Type DEVICE

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, 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No