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Fertil Steril. 2006 Jan;85(1):22-9.

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

Author information

  • 1Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. eastewart@partners.org

Erratum in

  • Fertil Steril. 2006 Apr;85(4):1072. Gastout, Bobbie [corrected to Gostout, Bobbie]; Gedroye, Wladyslaw M [corrected to Gedroyc, Wladyslaw M].

Abstract

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.

Comment in

PMID:
16412721
[PubMed - indexed for MEDLINE]
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