Project Summary

PCORI has identified treatment options for uterine fibroids as an important research topic. Uterine fibroids are common, non-cancerous growths in the uterus that often appear during childbearing years. Patients, clinicians, and others want to learn: “How can we help women make the best choice they can about how to manage their fibroids?” To help answer this question, PCORI partnered with the Agency for Healthcare Research and Quality (AHRQ) in 2013 to develop a registry to collect information on uterine fibroids, through the Patient-Centered Outcomes Research (PCOR) for Treatment Options in Uterine Fibroids: Developing a Prospective Multi-Center Practice-based Clinical Registry.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Uterine fibroids are growths in the uterus (womb) that do not cause cancer. They are one of the most common health problems in women of childbearing age. Fibroids are most common in women ages 35 to 45. Black women develop fibroids more often than women of other races do. Symptoms of fibroids include heavy bleeding, pain, and feelings of pressure in the belly. Some women have trouble getting pregnant because of their fibroids. Fibroids are often the reason women have surgery to remove the uterus, called a hysterectomy. Other treatments try to save as much of the uterus as possible while removing the fibroids.

Researchers want to know the benefits and risks of treatments for fibroids.

Who can this research help?

The results of this study can be used to help women and their doctors make decisions about how to manage uterine fibroids.

What is the research team doing?

The research team is setting up a registry to collect health data from women who get treatment for fibroids at health centers across the country. A registry is a system researchers use to collect similar data from many different patients with the same health problem. This information helps researchers learn about what treatments may work well in different situations.

The research team is working with nine medical centers. At these centers, the research team is recruiting 10,000 women between the ages of 18 and 54 who have been diagnosed with fibroids but are not entering menopause. At each center, patients and their doctors work together to make decisions about how to treat fibroids.  Treatment options include:

  • pain medicine
  • hormone treatment
  • procedures to destroy fibroid tissue with ultrasound or heat, or by stopping blood flow to the fibroid
  • hysterectomy to remove the entire uterus

The registry collects information about women’s medical histories and the symptoms they experience from their fibroids. It also collects information about their fibroids and the treatment options they choose. It collects information about how women feel after treatment and whether they have symptoms from their fibroids or their treatment. Researchers interview patients 1, 2, and 3 years after their treatment to find out if their symptoms have changed and whether women who want to have a baby have been able to become pregnant and give birth.

The research team is using the health data to run three studies. These studies each answer different questions:

  • Which treatments do a better job of dealing with problems caused by fibroids, like pain and heavy bleeding?
  • Which treatments make it easier for women with fibroids to have children?
  • Are some options better than others at meeting the treatment goals of women with different backgrounds and health histories?

The research team is also looking at other ways to use the data they collect to conduct research studies.

Research methods at a glance

Design Element Description
Design Observational: cohort study
Population Women aged 18-54 who have been diagnosed with uterine fibroids and are not in transition to menopause
Interventions/
Comparators
  • Medication
  • Hysterectomy
  • Myomectomy
  • Endometrial ablation
  • Magnetic resonance-guided focused ultrasound
  • Radiofrequency ablation
Outcomes

Primary: change in symptom relief

Secondary: change in preservation of reproductive function

Timeframe 3-year follow-up for primary outcome

Journal Articles

Results Highlights: Uterine fibroids—growths in the uterus that may cause heavy menstrual bleeding, pain, and feelings of abdominal pressure—are common health problems in women of childbearing age. They occur more frequently in African-American women than in women of other races. The PCORI-funded COMPARE-UF study set up a registry of women treated for fibroids to compare multiple outcomes of different treatment options. One study done using information from COMPARE-UF compared two types of uterine fibroid removal: hysterectomy, which is the removal of the uterus, and myomectomy, which is removal of only the fibroids. As published in Fertility and Sterility, both treatments increased quality of life one year after treatment. Depending on whether fibroid removal was done using abdominal or minimally invasive surgery, there were slight or no differences in quality of life.

Project Information

Evan R. Myers, MD, MPH
Duke University School of Medicine, Department of Obstetrics and Gynecology
$20,000,000

Key Dates

60 months
September 2019
2014

Study Registration Information

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Last updated: July 22, 2020