Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids.
OBJECTIVE
To assess outcomes at 6 and 12 months after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for symptomatic uterine leiomyomas.


METHODS
Multicenter clinical trial.


METHODS
Academic medical centers.


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


METHODS
A single treatment session of MRgFUS for uterine fibroids.


METHODS
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.


RESULTS
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.


CONCLUSIONS
MRgFUS treatment results in short-term symptom reduction for women with symptomatic uterine leiomyomas with an excellent safety profile.
Stewart
Elizabeth A
EA
Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. eastewart@partners.org
Rabinovici
Jaron
J
Tempany
Clare M C
CM
Inbar
Yael
Y
Regan
Leslie
L
Gostout
Bobbie
B
Gastout
Bobbie
B
Hesley
Gina
G
Kim
Hyun S
HS
Hengst
Suzanne
S
Gedroyc
Wladyslaw M
WM
Gedroye
Wladyslaw M
WM
D000328:Adult; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000601:surgery*; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D047648:Perimenopause; D011183:Postoperative Complications; D017697:Premenopause; D011788:Quality of Life; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000009:adverse effects / Q000379:methods*; D014594:Uterine Neoplasms / Q000601:surgery*