Evaluation of the Hyivy Device as a Non-hormonal Therapy in People With Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Overall self-reported pelvic pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall self-reported pelvic pain
时间窗: Baseline, 6-weeks, 12-weeks
Overall pelvic pain will be evaluated using a digital visual analog scale (VAS)
次要结局
- Sexual Function (FSFI)(Baseline, 6-weeks, 12-weeks)
- Feasibility of the Hyivy device(6-weeks, 12-weeks)
- Site-specific tenderness and pelvic floor muscle pain(Baseline, 6-weeks, 12-weeks)
- Adherence to study protocol(6-weeks, 12-weeks)
- Use of rescue medication(Baseline, 6-weeks, 12-weeks)
- Quality of Life (EHP-30)(Baseline, 6-weeks, 12-weeks)
- Safety and tolerability of the Hyivy device(Up to 12-weeks)