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. |
Professional Abstract
Objective
To compare the effectiveness of hysterectomy versus myomectomy in improving symptoms and quality of life among women with uterine fibroids
Study Design
Design Element | Description |
---|---|
Design | Observational: cohort study |
Population | 1,295 premenopausal women ages 18–54 with a diagnosis of uterine fibroids |
Interventions/ Comparators |
|
Outcomes |
Primary: symptom severity, fibroid-specific quality of life as measured by the Uterine Fibroid Symptom and health-related Quality of Life (UFS-QOL) questionnaire Secondary: health-related quality of life as measured by the EQ-5D-FL questionnaire |
Timeframe | 3-year follow-up for primary outcomes |
This observational prospective cohort study compared symptom relief and patient-reported quality of life among women who had a hysterectomy or a myomectomy to treat uterine fibroids. Hysterectomy is the removal of the uterus; myomectomy is the removal of one or more fibroids. Patients received either a hysterectomy or a myomectomy based on their personal preference and desire to get pregnant.
The study included 1,295 women with a diagnosis of uterine fibroids. Patients who enrolled in the study had a hysterectomy, myomectomy, or other procedure to treat their fibroids at one of eight clinical centers in 13 states. Of these patients, 40% were White, 39% were Black, and 21% were other races; 4% were Hispanic. The average age of patients who received a hysterectomy was 45; the average age of patients who received a myomectomy was 40.
Researchers collected data on patient-reported outcomes at baseline, at 6 to 12 weeks, and one, two, and three years after treatment. At baseline, researchers interviewed patients either in person or over the phone. For follow-up, patients completed surveys through an online data portal or by phone. Researchers controlled for differences in patient characteristics among women who chose either hysterectomy or myomectomy; patients who had a hysterectomy were older, were more likely to be White, and had a higher body mass index than patients who had a myomectomy.
Clinicians, patients, patient advocates, and health administrators helped design and conduct the study.
Results
After 6 to 12 weeks, patients who received a hysterectomy had lower symptom severity compared with those who received a myomectomy (95% confidence interval [CI]: -7.0, -2.3). This finding may reflect the fact that hysterectomy eliminates the possibility of having certain symptoms, such as bleeding.
After one year, patients who received a hysterectomy had higher quality of life (95% CI: 5.4, 17.2; p<0.01) and lower symptom severity (95% CI: -16.3, -8.8; p<0.01) than patients who received a myomectomy. Results were similar two and three years later. After three years, patients in both groups had significant improvements in fibroid-specific and health-related quality of life and symptom severity.
Limitations
The study did not have enough patients who had procedures other than hysterectomy and myomectomy to enable researchers to compare the effectiveness of other procedures.
Conclusions and Relevance
In this study, women who received a hysterectomy or myomectomy to treat uterine fibroids had improved symptom severity and quality of life during the three years after treatment.
Future Research Needs
Future research could compare the effectiveness of hysterectomy and myomectomy with other treatments for uterine 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
This project's final research report is expected to be available by February 2024.
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.
Results of This Project
Peer-Review Summary
The Peer-Review Summary for this project will be posted here soon.