Multicenter Trial On Minimally Invasive Fibroid Treatment

Main Category: Women's Health / Gynecology
Also Included In: Clinical Trials / Drug Trials;  Fertility;  Radiology / Nuclear Medicine
Article Date: 27 Feb 2008 - 4:00 PDT

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A new multicenter trial found that uterine artery embolization (UAE) is a good alternative to hysterectomy in women with symptomatic fibroids. The findings of the Embolisation versus Hysterectomy (EMMY) Trial appear in the March issue of the journal Radiology.

"After two years, patients who had undergone UAE reported health-related quality of life equal to that of women who had undergone hysterectomy," said study co-author Jim A. Reekers, M.D., Ph.D., an interventional radiologist at Academic Medical Centre in Amsterdam, Netherlands.

Uterine fibroids are benign growths of the muscle inside the uterus. According to the National Institutes of Health, at least 25 percent of women in the U.S. age 25 to 50 suffer from symptomatic uterine fibroids. Fibroid symptoms can include excessive menstrual bleeding, enlarged uterine size, frequent urination, pelvic pressure or pain and infertility.

According to the National Women's Health Information Center, fibroids are the primary reason for surgical removal of the uterus, accounting for approximately one-third of the 600,000 hysterectomies performed annually in the U.S.

UAE is a minimally invasive fibroid treatment in which catheters are placed in each of the two uterine arteries, and small particles are injected to block the arterial branches that supply blood to the fibroids. The fibroid tissue dies, the masses shrink and, in most cases, symptoms are relieved. UAE requires only a local anesthetic and has a shorter recovery period than hysterectomy.

"UAE has a number of benefits compared to hysterectomy," said co-author Wouter J.K. Hehenkamp, M.D., gynecology resident at Academic Medical Centre. "With UAE, there is a faster recovery time, a shorter hospital stay and, most importantly, the uterus is not removed."

For the EMMY trial, 177 women with uterine fibroids and heavy menstrual bleeding scheduled to undergo hysterectomy were randomly assigned to undergo UAE (88 women) or hysterectomy (89 women). During a 24-month follow-up period, 20 percent of women who had undergone embolization in the trial subsequently underwent hysterectomy due to insufficient symptomatic relief. Over the same period, health-related quality of life (HRQOL) was measured six times for all women in the trial with a series of scientifically validated questionnaires, which assessed various physical, mental and functional components contributing to quality of life, as well as overall satisfaction with the treatment.

Results showed that HRQOL improved significantly in all patients six months after treatment, except in the defecation distress inventory, which improved significantly in the UAE patients at six-month follow-up, but not the hysterectomy patients. Six weeks after treatment, the UAE patients also scored significantly higher scores on the physical component summary, which measured factors related to physical function.

After 24 months, no HRQOL differences were observed between the two groups, but while more than 90 percent of patients in both groups were at least moderately satisfied with the treatment they received, the hysterectomy patients reported a higher level of overall satisfaction. This may be attributable to the fact that they no longer experienced menstrual cycles or worried that their symptoms would recur. However, previous studies lasting several years have shown that it is rare for treated fibroids to regrow or for new fibroids to develop after UAE.

"For those women seeking absolute certainty of being asymptomatic after treatment, I would recommend a hysterectomy," Dr. Reekers said. "But for women who wish to retain their uterus and who desire a fast recovery, I would definitely recommend UAE."

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Article adapted by Medical News Today from original press release.
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For patient-friendly information on UAE and other radiological procedures, visit RadiologyInfo.org.

Radiology is a monthly scientific journal devoted to clinical radiology and allied sciences. The journal is edited by Herbert Y. Kressel, M.D., Harvard Medical School, Boston, Mass. Radiology is owned and published by the Radiological Society of North America, Inc. (RSNA.org/radiologyjnl)

The Radiological Society of North America (RSNA) is an association of more than 41,000 radiologists, radiation oncologists, medical physicists and related scientists committed to excellence in patient care through education and research. The Society is based in Oak Brook, Ill. (RSNA.org)

"Symptomatic Uterine Fibroids: Treatment with Uterine Artery Embolization or Hysterectomy - Results from the Randomized Clinical Embolisation versus Hysterectomy (EMMY) Trial." Collaborating with Drs. Hehenkamp and Reekers were Nicole A. Volkers, M.D., Erwin Birnie, Ph.D., and Willem M. Ankum, M.D., Ph.D.

Source: Maureen Morley
Radiological Society of North America