Results Summary

What was the research about?

Uterine fibroids are growths in the uterus, or womb. They are a common problem for women of childbearing age. Fibroids are not cancerous, but they can affect a woman’s quality of life and cause many symptoms. These symptoms may include pain and heavier bleeding during periods or bleeding between periods.

In this study, the research team compared two kinds of treatments for women with fibroids:

  • Hysterectomy, which is surgery to remove the entire uterus.
  • Myomectomy, which is surgery to remove uterine fibroids (also called myomas).

The research team wanted to learn how these two treatments improved patient outcomes, such as quality of life and severity of symptoms.

What were the results?

After 6–12 weeks, patients who had a hysterectomy had less severe symptoms than patients who had a myomectomy. This result may be partly because there can be no further bleeding once the uterus is removed by hysterectomy.

After one, two, and three years, patients who had a hysterectomy had higher quality of life and lower symptom severity than patients who had a myomectomy.

After three years, patients who had either surgery had improved quality of life and symptom relief.

Who was in the study?

The study included 1,295 women with fibroids. Of these patients, 40 percent were White, 39 percent were Black, and 21 percent were other races; 4 percent were Hispanic. The average age of patients who had a hysterectomy was 45. The average age of patients who had a myomectomy was 40.

What did the research team do?

The research team enrolled patients in the study who had treatments for their fibroids at one of eight clinics in 13 states. The team compared data for patients who received a hysterectomy or a myomectomy. Patients chose between the two treatments based on their personal preference, including their desire to get pregnant.

The research team gave patients surveys in person or over the phone at the start of the study. Patients took surveys through an online data portal or over the phone 6–12 weeks later and again one, two, and three years after their surgery.

Patients, patient advocates, health administrators, and doctors helped design and conduct the study.

What were the limits of the study?

The research team originally planned to compare more types of treatments. But because only a small number of patients chose other treatments, the team couldn’t compare treatments other than hysterotomy or myomectomy.

Future research could compare other treatments for fibroids.

How can people use the results?

Patients and doctors can use the results when considering ways to treat fibroids.

PCORI identified treatment options for uterine fibroids as an important research topic. Patients, clinicians, and others wanted to learn: How can we help women make the best choice they can about how to manage fibroids? To help answer this question, PCORI partnered with the Agency for Healthcare Research and Quality (AHRQ) to develop a Prospective Multi-Center Practice-based Clinical Registry to collect information on uterine fibroids and to support research projects using the registry data.

Final Research Report

View this project's final research report.

Journal Citations

Article Highlight: 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.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study. 

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.   

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following: 

  • The reviewers requested that the researchers provide more detailed descriptions of medical and surgical procedures they discuss in the report. The researchers expanded their descriptions so that the terminology would be clearer to readers unfamiliar with this clinical area. 

  • The reviewers noted that the researchers did not provide an estimated sample size for their analyses in the first study aim. The researchers explained that sample size estimates for analytic methods requiring some statistical adjustments are difficult to provide, and methods for simulating sample sizes are still new. They explained this in their limitations section. 

  • The reviewers asked about the potential impact on patient-reported outcomes from reading the regular study newsletters sharing some study results. The researchers acknowledged that a patient experiencing symptoms that are different from the norm described in a newsletter might react differently in further evaluations, but the researchers also explained that sharing the results was considered extremely important by patient stakeholders, and a common approach in longitudinal studies.

Conflict of Interest Disclosures

Project Information

Evan R. Myers, MD, MPH
Duke University
$65,729
10.25302/04.2023.MOU.AHRQ2013001PR
Comparing Options for Management: Patient-Centered Results for Uterine Fibroids (COMPARE-UF)

Key Dates

December 2022
2014
2023

Study Registration Information

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: February 20, 2024