Uterine leiomyomas: MR imaging-guided focused ultrasound surgery--results of different treatment protocols.
OBJECTIVE
To prospectively assess patient response (after 12 months) to magnetic resonance (MR) imaging-guided focused ultrasound surgery in treatment of uterine leiomyomas by using two treatment protocols.


METHODS
This prospective clinical trial was approved by institutional review boards and was HIPAA compliant. After giving informed consent, patients with symptomatic leiomyomas were consecutively enrolled and treated at one of five U.S. centers by using an original or a modified protocol. Outcomes were assessed with the symptom severity score (SSS) obtained at baseline and 3, 6, and 12 months after treatment. Adverse events (AEs) were recorded. Statistical analysis included Student t test, Fisher exact test, analysis of covariance, Spearman correlation, and logistic regression.


RESULTS
One hundred sixty patients had a mean SSS of 62.1 +/- 16.3 (standard deviation) at baseline, which decreased to 35.5 +/- 19.5 at 3 months (P<.001) and to 32.3 +/- 19.8 at 6 months (P<.001) and was 32.7 +/- 21.0 at 12 months (P<.001). Ninety-six patients (mean age, 46.0 years +/- 4.6) were treated with an original protocol, and 64 (mean age, 45.9 years +/- 3.9) were treated with a modified protocol. Patients in the modified group had a significantly greater SSS decrease at 3 months (P=.037) than those in the original group, and 73% of those in the original group and 91% of those in the modified group reported a significant decrease in SSS (of 10 points or greater) at 12 months. No serious AEs were recorded. Fewer AEs were reported in the modified group than in the original group (25% vs 13% reporting no event). Of evaluable patients, fewer in the modified group chose alternative treatment (28%) than in the original group (37%).


CONCLUSIONS
MR imaging-guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.
Fennessy
Fiona M
FM
Department of Radiology, Harvard Medical School/Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA. ffennessy@partners.org
Tempany
Clare M
CM
McDannold
Nathan J
NJ
So
Minna J
MJ
Hesley
Gina
G
Gostout
Bobbie
B
Kim
Hyun S
HS
Holland
George A
GA
Sarti
Dennis A
DA
Hynynen
Kullervo
K
Jolesz
Ferenc A
FA
Stewart
Elizabeth A
EA
D000328:Adult; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000175:diagnosis* / Q000628:therapy*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D013813:Therapy, Computer-Assisted / Q000379:methods*; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000379:methods*; D014594:Uterine Neoplasms / Q000175:diagnosis* / Q000628:therapy*