What side effects are associated with this type of intervention?

Common treatments for endometriosis include hormonal therapies such as estrogen-progestin contraceptives, GnRH agonists, and progestins like dienogest. These treatments can have side effects such as bone density loss, hot flashes, decreased libido, and mood changes. Physical therapy methods, including heat, vibration, or electrical stimulation, are generally well-tolerated but may cause temporary discomfort or irritation at the application site. These methods aim to alleviate pain and improve pelvic muscle function without the systemic side effects associated with hormonal treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, primarily focusing on hormonal therapies. These include gonadotropin-releasing hormone (GnRH) agonists like leuprolide, which reduce estrogen production, and progestins like norethindrone acetate. Non-hormonal treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) are also commonly used to manage pain. While the Hyivy device's approach using physical therapy methods like heat, vibration, or electrical stimulation is innovative, there is limited information on FDA-approved treatments specifically utilizing these modalities for endometriosis.

What other types of research exist?

Promising novel alternatives to the Hyivy device for endometriosis treatment in 2024 include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which has shown efficacy in managing chronic pain conditions; 2) High-frequency Spinal Cord Stimulation (SCS), which has been effective in treating chronic back and leg pain and may offer benefits for pelvic pain; 3) Acupuncture, which has been suggested to improve outcomes in pain management; and 4) Integrative therapies such as mindfulness-based practices and yoga, which can help manage pain and improve quality of life.

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N/A

Hyivy Device for Endometriosis (endometriosis Trial)

N/A

Waitlist Available

Led By Mathew Leonardi, M.D.

Research Sponsored by Hyivy Health Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

4.Diagnosed with chronic pelvic pain (self-reported pain in pelvic area lasting >3 months)

VAS for overall pelvic pain ≥ 4 at screening and baseline

Must not have

Active vaginal infection (e.g. vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, STIs)

Current use of antibiotics and a history of vulvovaginal candidiasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-weeks, 12-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the Hyivy device, which is designed to help reduce pelvic pain. The study focuses on people with endometriosis, a condition that causes significant pelvic pain. The device likely uses physical therapy methods to ease this pain.

Who is the study for?

This trial is for adults over 18 with endometriosis and chronic pelvic pain lasting more than 3 months. Participants must be in good health otherwise, have been managing endometriosis with hormones for at least 3 months, and be willing to use an intravaginal device. They can't start new treatments or physiotherapy during the study, nor have conditions like active infections or recent surgeries that could interfere.

What is being tested?

The Hyivy device is being tested to see if it reduces self-reported pelvic pain in individuals with endometriosis. The study involves participants using this intravaginal device regularly and monitoring their pain levels without starting any other new treatments.

What are the potential side effects?

Potential side effects are not specified but may include discomfort or reactions related to inserting the intravaginal device, based on individual sensitivities to the material of the Hyivy device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had pelvic pain for more than 3 months.

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My pelvic pain level is 4 or higher.

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I can charge the device needed for the trial.

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I am willing and able to use an intravaginal device.

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I am 18 years old or older.

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I am 18 years old or older.

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I have been diagnosed with endometriosis.

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I agree not to start any new treatments for 12 weeks.

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I have had pelvic pain for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active vaginal infection.

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I am currently taking antibiotics and have had yeast infections before.

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I have had surgery in the last 3 months or expect to have surgery during the study.

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I have chronic pelvic pain not caused by endometriosis.

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I understand and am willing to participate in the study.

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I have been diagnosed with early menopause.

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I am currently seeing a pelvic floor physiotherapist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-weeks, 12-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-weeks, 12-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-weeks, 12-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall self-reported pelvic pain

Secondary study objectives

Adherence to study protocol

Feasibility of the Hyivy device

Quality of Life (EHP-30)

+4 more

Other study objectives

Autonomic function

Device usability and patient satisfaction

Emergency room (ER) visits

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hyivy Intravaginal DeviceExperimental Treatment1 Intervention

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.

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometriosis include hormonal therapies, surgical interventions, and physical therapies. Hormonal treatments, such as combined estrogen-progestin contraceptives and GnRH agonists, work by suppressing ovarian function, leading to the decidualization and atrophy of endometrial tissue, thereby reducing pain and disease progression. Surgical options aim to remove or reduce endometrial lesions. Physical therapies, including those using heat, vibration, or electrical stimulation, help alleviate pain by relaxing pelvic muscles, improving blood flow, and reducing inflammation. Understanding these mechanisms is crucial for endometriosis patients as it helps them make informed decisions about their treatment options, balancing efficacy and potential side effects.

A deep insight into pelvic pain and endometriosis: a review of the literature from pathophysiology to clinical expressions.Assessment of ovarian reserve after cystectomy versus 'one-step' laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial.