Endometriosis, Pelvic Pain
Conditions
Keywords
Endometriosis, Pelvic Pain, Dilator
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.
Interventions
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.
Sponsors
McMaster University
Hyivy Health Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (Open Label)
Intervention model description
Prospective observational pre/post repeated-measures pilot intervention study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall self-reported pelvic pain | Baseline, 6-weeks, 12-weeks | Overall pelvic pain will be evaluated using a digital visual analog scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Safety and tolerability of the Hyivy device | Up to 12-weeks | Occurrence of adverse events (AE) and serious adverse events (SAE). |
| 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. |
| Feasibility of the Hyivy device | 6-weeks, 12-weeks | Device usage will be assessed with a study-specific questionnaire. |
| 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. |
| 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 |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Emergency room (ER) visits | Baseline, 6-weeks, 12-weeks | Number of ER visits due to chronic pelvic pain in the last 6 weeks |
| Device usability and patient satisfaction | 12-weeks | Study-specific questionnaire to gather patient feedback |
| Autonomic function | Baseline, 6-weeks, 12-weeks | 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. |
| Peripheral gene expression | Baseline, 6-weeks, 12-weeks | Changes in peripheral inflammation as assessed by a protein biomarker panel before and after device use |
Countries
Canada
Contacts
Primary ContactMathew Leonardi, M.D.
Outcome results
None listed