Clinical trial NCT05643131: Hyivy Device as Non-hormonal Therapy in Endometriosis
Official title: Evaluation of the Hyivy Device as a Non-hormonal Therapy in People With Endometriosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Pelvic Pain
Keywords: Endometriosis
Pelvic Pain
Dilator
Lead sponsor: Hyivy Health Inc
Sponsor class: INDUSTRY
Collaborators: name: McMaster University
First posted: 2022-12-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational pre/post repeated-measures pilot intervention study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall self-reported pelvic pain
timeFrame: Baseline, 6-weeks, 12-weeks
Secondary outcomes:
measure: Site-specific tenderness and pelvic floor muscle pain
timeFrame: Baseline, 6-weeks, 12-weeks
measure: Quality of Life (EHP-30)
timeFrame: Baseline, 6-weeks, 12-weeks
measure: Sexual Function (FSFI)
timeFrame: Baseline, 6-weeks, 12-weeks
measure: Safety and tolerability of the Hyivy device
timeFrame: Up to 12-weeks
measure: Adherence to study protocol
timeFrame: 6-weeks, 12-weeks
measure: Feasibility of the Hyivy device
timeFrame: 6-weeks, 12-weeks
measure: Use of rescue medication
timeFrame: Baseline, 6-weeks, 12-weeks
Other outcomes:
measure: Autonomic function
timeFrame: Baseline, 6-weeks, 12-weeks
measure: Peripheral gene expression
timeFrame: Baseline, 6-weeks, 12-weeks
measure: Emergency room (ER) visits
timeFrame: Baseline, 6-weeks, 12-weeks
measure: Device usability and patient satisfaction
timeFrame: 12-weeks
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
Study officials:
affiliation: McMaster University Medical Centre
name: Mathew Leonardi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh S, Soliman AM, Rahal Y, Robert C, Defoy I, Nisbet P, Leyland N. Prevalence, Symptomatic Burden, and Diagnosis of Endometriosis in Canada: Cross-Sectional Survey of 30 000 Women. J Obstet Gynaecol Can. 2020 Jul;42(7):829-838. doi: 10.1016/j.jogc.2019.10.038. Epub 2020 Jan 27.
citation: Kong S, Zhang YH, Liu CF, Tsui I, Guo Y, Ai BB, Han FJ. The complementary and alternative medicine for endometriosis: a review of utilization and mechanism. Evid Based Complement Alternat Med. 2014;2014:146383. doi: 10.1155/2014/146383. Epub 2014 Feb 19.
citation: Vercellini P, Vigano P, Somigliana E, Fedele L. Endometriosis: pathogenesis and treatment. Nat Rev Endocrinol. 2014 May;10(5):261-75. doi: 10.1038/nrendo.2013.255. Epub 2013 Dec 24.
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citation: As-Sanie S, Black R, Giudice LC, Gray Valbrun T, Gupta J, Jones B, Laufer MR, Milspaw AT, Missmer SA, Norman A, Taylor RN, Wallace K, Williams Z, Yong PJ, Nebel RA. Assessing research gaps and unmet needs in endometriosis. Am J Obstet Gynecol. 2019 Aug;221(2):86-94. doi: 10.1016/j.ajog.2019.02.033. Epub 2019 Feb 18.
citation: Duffy J, Hirsch M, Vercoe M, Abbott J, Barker C, Collura B, Drake R, Evers J, Hickey M, Horne AW, Hull ML, Kolekar S, Lensen S, Johnson NP, Mahajan V, Mol BW, Otter AS, Puscasiu L, Rodriguez MB, Rombauts L, Vail A, Wang R, Farquhar CM; endo:outcomes - an International Collaboration Harmonising Outcomes and Outcome Measures for Endometriosis Research. A core outcome set for future endometriosis research: an international consensus development study. BJOG. 2020 Jul;127(8):967-974. doi: 10.1111/1471-0528.16157. Epub 2020 Mar 30.
citation: Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090. Epub 2011 Jun 30.