Patient Centered Results for Uterine Fibroids

Study Overview
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Brief Summary
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The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF. Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.

Detailed Description
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COMPARE UF will enroll approximately 10,000 subjects across 9 clinical enrolling centers in the US. We anticipate recruitment to last approximately 24 months. Sites will consent interested patients and have them complete a patient contact information form to be used to contact the patient for telephone interviews. Following informed consent, the site will collect clinical information and several patient-reported outcomes scales, including the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL), the Menopausal Rating Scale, and the EQ-5D, a standardized measure of general health outcomes. In year 01 of this study, among patients receiving a procedure to treat their UF, 1000 will be asked to provide two blood samples: the first at time of enrollment (before the procedure) and the second at 12 months after the procedure. Samples will be evaluated for ovarian reserve via a blood assay measurement of anti-mullerian hormone. Additionally, for patients who have a procedure to treat their UF, they will have a routine clinic follow-up visit, sometime between 6 - 12 weeks post procedure. Additional clinical data will be collected at this time. For patients who are treated medically, there will be no further study-related clinic visits. Follow-up will occur exclusively by telephone. All consented patients will complete telephone interviews at approximately 12, 24, and 36 months following the initial procedure. It is anticipated that patients enrolled during the first study year will complete a maximum of three years of follow-up. However, if additional funds become available, the investigators plan to extend the follow-up of enrolled patients to five years.

Official Title
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Comparing Options for Management: Patient Centered Results for Uterine Fibroids

Conditions
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Fibroids, Uterine

Intervention / Treatment
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* Procedure: hysterectomy
* Procedure: Uterine arterial embolization
* Procedure: myomectomy
* Drug: Medical Therapy
* Procedure: endometrial ablation
* Procedure: magnetic resonance guided focused ultrasound
* Procedure: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of UF by imaging or pathology report within 2 years of enrollment initiation. Menstrual period within 12 months Exclusion Criteria: Post-menopausal Men 55 years old or older

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical<br>Patients who receive medical therapy only for treatment of their uterine fibroids | Drug: Medical Therapy<br>* treatment of uterine fibroids with only medications, no procedure or surgery is used<br>|
| Procedure<br>Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF. | Procedure: hysterectomy<br>* surgical removal of the uterus<br>Procedure: Uterine arterial embolization<br>* In uterine artery embolization, doctor uses a slender, flexible tube (catheter) to inject small particles (embolic agents) into the uterine arteries, which supply blood to your fibroids and uterus.the embolic agents are injected into these fibroid blood vessels. The goal is to block the fibroid vessels, starving the fibroids and causing them to shrink and die.<br>* Other names: UAE;Procedure: myomectomy<br>* surgical procedure to remove uterine fibroids, but does not remove uterus<br>Procedure: endometrial ablation<br>* surgical procedure that destroys uterine lining via a telescope placed inside the uterus<br>* Other names: NovaSure, Her Option, HydroTherm;Procedure: magnetic resonance guided focused ultrasound<br>* procedure that destroys fibroids while inside an MRI machine<br>* Other names: MRgFUS, ExAblate; Sonalleve;Procedure: radiofrequency ablation<br>* procedure that uses heat to destroy uterine fibroids<br>* Other names: Accessa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in symptom relief (patient interview) | degree to which bleeding and pain from uterine fibroids is alleviated | 12, 24, 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in preservation reproductive function (patient interview) | ability of a woman after receiving treatment for uterine fibroids can conceive and deliver a healthy baby | 12, 24, 36 months |