Fairfax, Virginia (January 2, 2008) – Three-year data from the largest, multi-center,

prospective voluntary registry on any procedure for benign uterine fibroids showed that

90 percent of the women participating avoided a hysterectomy and of these, 85 percent

had a substantial improvement in symptoms and quality of life. The registry included

three-year data on 1,278 patients from 26 sites who had this minimally invasive

interventional radiology treatment for symptomatic fibroids, showing uterine fibroid

embolization is a durable treatment for fibroids with sustained improvement in quality of

life and symptom relief. Twenty to 40 percent of American women age 35 and older, and

nearly 50 percent of pre-menopausal African American women, have uterine fibroids. Of

the 600,000 hysterectomies performed annually in the United States, one-third of these

are to relieve symptoms caused by fibroids. “This registry data is great news for women.

With uterine fibroid embolization, we could significantly decrease the hysterectomy rate

in the United States” says Scott Goodwin, MD, interventional radiologist and lead author.

Uterine fibroids are benign tumors that can cause prolonged, heavy menstrual bleeding

that can be severe enough to cause anemia or require transfusion, disabling pelvic pain

and pressure, urinary frequency, pain during intercourse, miscarriage, interference with

fertility, and an abnormally large uterus resembling pregnancy. UFE is a minimally

invasive interventional radiology treatment that blocks the blood supply to the fibroid

tumors, causing them to shrink and die, and symptoms to subside.

The FIBROID Registry was designed to follow the “real world” outcomes for uterine

fibroid embolization as it became a mainstream treatment widely available across the

country. The purpose of the Registry was to assess the procedure’s effectiveness in

improving fibroid-related symptoms, to determine the durability of those improvements,

and to assess the safety of the procedure in broad practice. The 1,278 women who

completed the three-year follow-up had significant improvement in symptoms and in

quality of life (QOL), moving them into the normal range on this validated survey

instrument. The mean symptom scores before embolization were 58.61, and postprocedure

at three years were 16.54. Mean QOL scores pre-embolization were 46.95 and

at three years were 89.55. Eighty-five percent would recommend the procedure to a

family member or friend. The study also identified subgroups of patients that appeared to

have a greater likelihood of improvement.

This data shows that the long-term clinical outcomes of UFE are consistent when the

procedure is performed in any experienced community or academic interventional

radiology practice. “The Registry’s outcomes are important not only because of its size,

but also because of the diversity of sites that participated. These results demonstrate that

uterine fibroid embolization is safe and very effective beyond the academic or specialized

centers.” The Registry is one of the few efforts ever undertaken to study the efficacy of a

procedure as it disseminates into broad practice, and this is the first such effort for a

fibroid therapy by any specialty.

“It is important for women to know all of their treatment options in order to make an

informed decision. Interventional radiologists can provide a second opinion and assess

whether UFE is a treatment option. The vast majority of women are eligible for this

treatment,” says Goodwin. Interventional radiologists use MRI to delineate the location

of each fibroid, determine if a tumor can be embolized, detect alternate causes for the

symptoms, identify pathology that could prevent a women from having UFE, and avoid

ineffective treatments. The number of women requiring retreatment after UFE in the

registry is similar to the surgical reintervention rates, of approximately five percent per

year, following myomectomy.

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