Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids

An abstract of this work was presented at the Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, which was held in Philadelphia, Pennsylvania, in May 2004.

Received 7 January 2005; received in revised form 15 April 2005; accepted 15 April 2005.

Refers to erratum:

Erratum
Fertility and Sterility
April 2006 (Vol. 85, Issue 4, Page 1072)
Full Text | Full-Text PDF (37 KB)

Objective

To assess outcomes at 6 and 12 months after magnetic resonance–guided focused ultrasound surgery (MRgFUS) for symptomatic uterine leiomyomas.

Design

Multicenter clinical trial.

Setting

Academic medical centers.

Patient(s)

Premenopausal women with symptomatic uterine leiomyomas and no plans for future pregnancy (n = 109 at 6 months and n = 82 at 12 months).

Intervention(s)

A single treatment session of MRgFUS for uterine fibroids.

Main Outcome Measure(s)

Reduction in fibroid symptoms as measured by the symptom severity score (SSS) of the Uterine Fibroid Quality-of-Life Instrument (UFS-QOL), the only validated measure of leiomyoma symptomatology. A 10-point reduction in the SSS was selected as the targeted improvement.

Result(s)

Seventy-one percent of women undergoing MRgFUS reached the targeted symptom reduction at 6 months, and 51% reached this at 12 months. The magnitude of improvement in SSS was greater than predicted, with subjects having a mean decrease of 39% and 36% at 6 and 12 months, respectively. This paralleled the improvement seen using the short form-36 instrument. A modest volume reduction similar in magnitude to the treated volume was seen. The incidence of adverse events was low.

Conclusion(s)

MRgFUS treatment results in short-term symptom reduction for women with symptomatic uterine leiomyomas with an excellent safety profile.

Key Words: Leiomyomas , focused ultrasound , magnetic resonance imaging

a Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

b Department of Radiology, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

c Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Israel

d Radiology, Sheba Medical Center, Tel-Hashomer, Israel

e Department of Obstetrics and Gynecology, St. Mary’s Hospital, London, United Kingdom

f Department of Radiology, St. Mary’s Hospital, London, United Kingdom

g Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA

h Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA

i Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

j Department of Radiology, Charité Medical Center and Humboldt University, Berlin, Germany

Reprint requests: Elizabeth A. Stewart, M.D., Center for Uterine Fibroids, Brigham and Women’s Hospital, 75 Francis Street, Boston, Massachusetts 02115 (FAX: 617-566-7752)

Supported and funded by Insightec, Ltd., Haifa, Israel.

The following individuals also contributed to this work: Michael A. Jacobs, Ph.D., Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland; Jonathan Hindley, Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Israel; Simcha Yagel, M.D., Department of Obstetrics and Gynecology, Hadassah Medical Center, Jerusalem, Israel; Tilman Ehrenstein, M.D., and Miri Sklair Levy, M.D., Department of Radiology, Charité Medical Center and Humboldt University, Berlin, Germany; and Ferenc A. Jolesz, M.D., Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts.

PII: S0015-0282(05)03655-1

doi:10.1016/j.fertnstert.2005.04.072

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