title: Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids.
abstract: 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.
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. eastewart@partners.org
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Stewart
authors.forename: Jaron
authors.initials: J
authors.lastname: Rabinovici
authors.forename: Clare M C
authors.initials: CM
authors.lastname: Tempany
authors.forename: Yael
authors.initials: Y
authors.lastname: Inbar
authors.forename: Leslie
authors.initials: L
authors.lastname: Regan
authors.forename: Bobbie
authors.initials: B
authors.lastname: Gostout
authors.forename: Bobbie
authors.initials: B
authors.lastname: Gastout
authors.forename: Gina
authors.initials: G
authors.lastname: Hesley
authors.forename: Hyun S
authors.initials: HS
authors.lastname: Kim
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hengst
authors.forename: Wladyslaw M
authors.initials: WM
authors.lastname: Gedroyc
authors.forename: Wladyslaw M
authors.initials: WM
authors.lastname: Gedroye
mesh_terms: 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*