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Non-Surgical Fibroid Option Has Long-Lasting Effects: Study

Women who undergo a non-surgical treatment option for painful uterine fibroids can rest assured that the therapy's effects will be long lasting, says a new study. The treatment is known as uterine fibroid embolization, or UFE, and was the focus of  a new clinical trial released at the annual meeting of the American Society for Interventional Radiology this month.1

Women 'Will be Hearing More' about UFE
While some doctors have been reluctant to offer patients UFE as an option due to limited information on its long-term effectiveness, this study's researchers say they're confident that many of the questions have been answered. "Some gynecologists have been waiting for long-term data before being comfortable recommending the UFE procedure," said James Spies, MD, the study's chief investigator, "and now that we have that data, I think women will be hearing more about UFE as a nonsurgical option."

"I think this study is the first to provide data to address that concern," said Spies, a professor of Interventional Radiology at Georgetown University Medical Center.

Fibroids and Therapy Options
Uterine fibroids are known in medical terms as uterine leiomyomata (YOO-ter-ihn lie-oh-my-oh-MAH-tah). It's a fairly common condition, affecting at least 25 percent of women in the U.S. Fibroids are tumors or lumps made of muscle cells and other tissue that grow within the wall of the uterus. They can grow alone or in clusters. The cause of these growths is unknown, but scientists have theorized that they may be the end result of a collection of factors interacting with each other. These factors could be genetic, hormonal, environmental, or a combination.2

Symptoms of uterine fibroids include heavy or painful periods; bleeding between periods; a feeling of fullness in the lower abdomen; frequent urination; pain during sex; lower back pain; and reproductive complications like infertility, multiple miscarriages, and early labor in pregnancy.2

Uterine fibroid (or artery) embolization is a minimally invasive procedure used to block the arteries that supply blood to these unwanted tumors. In the end, they shrink. The technique requires only a tiny nick in the skin and doctors perform it while the patient is conscious and sedated. An interventional radiologist inserts a tiny catheter into the femoral artery in the groin, then feeds it through the artery into the uterus. When it reaches arteries feeding the fibroids, the doctor then injects tiny plastic particles about the size of sand grains into the blood vessels, cutting off blood flow to the fibroids. At the end of the procedure, the catheter is removed and the nick is cleaned and covered with a bandage.3

Today, UFE is offered to women who would otherwise undergo a hysterectomy, and myomectomy is typically reserved for younger women seeking pregnancy in the future, Spies explained. "UAE is becoming progressively popular because it is minimally-invasive and allows a rapid recovery. It therefore may sway some women to choose UAE who would otherwise have a myomectomy," Spies told Priority Healthcare.

While there are no instances in which UFE cannot be performed, he says women "with uteri up to 24 weeks size (pregnancy weeks) and who have most of their fibroids within the main body of the uterus" usually have better outcomes.

Long-Term Monitoring After UFE
In their prospective trial whose data were presented at the medical conference on April 1, Spies and his team followed nearly 200 patients for up to 5 years after they had undergone UFE. Each patient was given a questionnaire asking them about various symptoms and their quality of life. Their symptoms and menstrual cycle regularity were also evaluated during the follow-up period.

One year after treatment, 87 percent of the patients continued to experience improved symptoms, while eight-and-a-half percent experienced treatment failure, defined has undergoing hysterectomy, myomectomy, or repeat embolization, wrote Spies and his associates. An additional 5 percent of the patients saw no improvement after one year.

Even four years postoperatively, more than 80 percent of the patients were still experiencing symptom improvement, Spies' team reported, while nearly 16 percent had treatment failure. Five years later, about one-fourth of the patients were considered to have failed treatment, but 72 percent still had improved symptoms.

"With any of the uterine-sparing treatments, growth of new fibroids is possible, and we saw this occurring in some patients during the later part of this follow-up study," Spies said. "[However], the same phenomenon is seen with myomectomy, with reintervention rates in the same range."

What's the study's take-home message? "It demonstrates that there is sustained symptom control and patient satisfaction in the large majority of these patients, a group that had, in general, very extensive fibroid disease," he said.

UFE Compared to Hysterectomy
This isn't the first trial of UFE's effectiveness involving Spies and his colleagues. Last year, the researchers compared the outcomes of UFE versus hysterectomy for uterine fibroids in a smaller study of 152 women.4

The investigators measured changes in symptoms, complications, and quality of life in the group of patients who underwent either procedure. While both groups had similarly significant improvements in symptoms and quality of life, "complications were more frequent in patients who underwent hysterectomy," the study team noted. Hysterectomy did have a greater advantage, however, in terms of pelvic pain, they found.

But studies on the effectiveness of UFE are far from over. "The next step in fibroid research is to design direct comparative studies between the various therapies to provide data as to which patients are best suited for each treatment," Spies said.

Additionally, experts agree that more work is needed "to better characterize the potential impact of these therapies (specifically UAE and myomectomy) on ovarian function and endometrial function," he said.

1. Spies JB, Bruno J, Roth AR, Czeyda-Pommersheim F, Magee ST, Sterbis K. Long-term outcome from uterine embolization for fibroids (Abstract 15). American Society of Interventional Radiology. 30th Annual Meeting. 2005 Mar 31-Apr 5. New Orleans, LA.
2. National Institute of Child Health and Human Development (NICHD). National Institutes of Health (NIH). Available at: http://www.nichd.nih.gov/publications/pubs/fibroids/sub1.htm#what. Accessed April 5, 2005.
3. Society of Interventional Radiology. Uterine Fibroid Treatment Options. Available at: http://www.sirweb.org/patPub/uterineTreatments.shtml#uf. Accessed April 5, 2005.
4. Spies JB, Cooper JM, Worthington-Kirsch R, Lipman JC, Mills BB, Benenati JF. Outcome of uterine embolization and hysterectomy for leiomyomas: results of a multicenter study. Am J Obstet Gynecol 2004 Jul;191(1):22-31.

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.


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