A registry to document the treatment of uterine fibroids and outcome of patients has been established at the Duke Clinical Research Institute (DCRI) in Durham, N.C. The DCRI will be the research and data coordination center for a five year project enrolling more than 10,000 women at nine medical centers in the United States.
The objective of the study is to determine which procedures provide the greatest benefit to women with uterine fibroids. Current treatments to be evaluated are hysterectomy, myomectomy, endometrial ablation, radiofrequency ablation, uterine artery embolization, and MR-guided focused ultrasound (MRG-FUS). Patients enrolled in the study must have a documented diagnosis of uterine fibroids, be older than age 18, and still have menstrual periods. Participants will be asked specific questions on an annual basis about the treatments they received and how well the treatments are working for them. Studies using registry data will focus on symptom relief, reproductive effects, and effectiveness among different patient subgroups. Researchers at DCRI will begin an analysis of patients starting 36 months after their initial treatment.
The registry is called Comparing Options for Management: Patient-Centered Results for Uterine Fibroids (COMPARE-UF). It was funded in 2013 with a $20 million funding award from the Patient-Centered Outcomes Research Institute (PCORI) in partnership with the Agency for Healthcare Research and Quality (AHRQ). Enrollment sites include the Mayo Clinic Collaborative Network, University of California Fibroid Network, Henry Ford Health System, University of Mississippi Medical Center, Inova Health Systems, and the Department of Defense Clinical Consortium. The University of Michigan will become an enrollment site later in 2016.
Principal investigator Evan Myers, MD, a professor of obstetrics and gynecology at Duke University School of Medicine commented that uterine fibroids “affect up to 75% of women to varying degrees and is the leading cause of hysterectomies in the country - yet we don’t know which treatment works best for a given patient. Patients have clearly stated they wanted these questions answered, but preferred a registry to randomized trials, particularly because hysterectomy is one of the current options.”Back To Top
Treatment registry for uterine fibroids established at Duke. Appl Radiol.