Patient Centered Results for Uterine Fibroids

Completed

• Conditions: Fibroids, Uterine
• Interventions: Procedure: hysterectomy; Drug: Medical Therapy; Procedure: Uterine arterial embolization; Procedure: myomectomy; Procedure: endometrial ablation; Procedure: magnetic resonance guided focused ultrasound; Procedure: radiofrequency ablation

• Registration Number: NCT02260752
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Study Start: 2015-11
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3094

Inclusion Criteria

• Diagnosis of UF by imaging or pathology report within 2 years of enrollment initiation.
• Menstrual period within 12 months

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Exclusion Criteria

• Post-menopausal
• Men
• 55 years old or older

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Procedure	hysterectomy	Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
Procedure	magnetic resonance guided focused ultrasound	Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
Procedure	Uterine arterial embolization	Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
Medical	Medical Therapy	Patients who receive medical therapy only for treatment of their uterine fibroids
Procedure	radiofrequency ablation	Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
Procedure	myomectomy	Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
Procedure	endometrial ablation	Patients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.

Primary Outcome Measures

Name	Time	Method
change in symptom relief (patient interview)	12, 24, 36 months	degree to which bleeding and pain from uterine fibroids is alleviated

Secondary Outcome Measures

Name	Time	Method
change in preservation reproductive function (patient interview)	12, 24, 36 months	ability of a woman after receiving treatment for uterine fibroids can conceive and deliver a healthy baby

Trial Locations

Locations (9)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of California Medical Centers; 🇺🇸 San Francisco, California, United States

Uniformed Services University of the Health Sciences; 🇺🇸 Bethesda, Maryland, United States

Inova Health Systems; 🇺🇸 Falls Church, Virginia, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States