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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
McMaster University Medical Centre
Hamilton, Ontario, Canada
Overall self-reported pelvic pain
Overall pelvic pain will be evaluated using a digital visual analog scale (VAS)
Time frame: Baseline, 6-weeks, 12-weeks
Site-specific tenderness and pelvic floor muscle pain
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
Time frame: Baseline, 6-weeks, 12-weeks
Quality of Life (EHP-30)
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).
Time frame: Baseline, 6-weeks, 12-weeks
Sexual Function (FSFI)
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.
Time frame: Baseline, 6-weeks, 12-weeks
Safety and tolerability of the Hyivy device
Occurrence of adverse events (AE) and serious adverse events (SAE).
Time frame: Up to 12-weeks
Adherence to study protocol
Usage data collected by the Hyivy device will be used to assess participant adherence to the study regimen of 3 times/week device use.
Time frame: 6-weeks, 12-weeks
Feasibility of the Hyivy device
Device usage will be assessed with a study-specific questionnaire.
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Time frame: 6-weeks, 12-weeks
Use of rescue medication
Changes in the use of rescue medications for chronic pelvic pain, assessed with a study-specific questionnaire.
Time frame: Baseline, 6-weeks, 12-weeks