title: PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids.
abstract: OBJECTIVE
  To evaluate the feasibility of a full-scale placebo-controlled trial of magnetic resonance-guided focused ultrasound for fibroids (MRgFUS) and obtain estimates of safety and efficacy.
  
  
  METHODS
  Pilot, randomized, placebo-controlled trial.
  
  
  METHODS
  University medical center.
  
  
  METHODS
  Premenopausal women with symptomatic uterine fibroids.
  
  
  METHODS
  Participants randomized in a 2:1 ratio to receive MRgFUS or placebo procedure.
  
  
  METHODS
  
  
  
  METHODS
  change in fibroid symptoms from baseline to 4 and 12 weeks after treatment assessed by the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL); secondary outcome: incidence of surgery or procedures for recurrent symptoms at 12 and 24 months.
  
  
  RESULTS
  Twenty women with a mean age of 44 years (±standard deviation 5.4 years) were enrolled, and 13 were randomly assigned to MRgFUS and 7 to placebo. Four weeks after treatment, all participants reported improvement in the UFS-QOL: a mean of 10 points in the MRgFUS group and 9 points in the placebo group (for difference in change between groups). By 12 weeks, the MRgFUS group had improved more than the placebo group (mean 31 points and 13 points, respectively). The mean fibroid volume decreased 18% in the MRgFUS group with no decrease in the placebo group at 12 weeks. Two years after MRgFUS, 4 of 12 women who had a follow-up evaluation (30%) had undergone another fibroid surgery or procedure.
  
  
  CONCLUSIONS
  Women with fibroids were willing to enroll in a randomized, placebo-controlled trial of MRgFUS. A placebo effect may explain some of the improvement in fibroid-related symptoms observed in the first 12 weeks after MRgFUS.
  
  
  BACKGROUND
  NCT01377519.
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California. Electronic address: jacobyv@obgyn.ucsf.edu.
authors.forename: Vanessa L
authors.initials: VL
authors.lastname: Jacoby
authors.affiliation: Department of Radiology and Biomedical Imaging, University of California, San Francisco, California.
authors.forename: Maureen P
authors.initials: MP
authors.lastname: Kohi
authors.affiliation: Department of Radiology and Biomedical Imaging, University of California, San Francisco, California.
authors.forename: Liina
authors.initials: L
authors.lastname: Poder
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California.
authors.forename: Alison
authors.initials: A
authors.lastname: Jacoby
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California.
authors.forename: Jeanette
authors.initials: J
authors.lastname: Lager
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California.
authors.forename: Michael
authors.initials: M
authors.lastname: Schembri
authors.affiliation: Department of Radiology and Biomedical Imaging, University of California, San Francisco, California.
authors.forename: Viola
authors.initials: V
authors.lastname: Rieke
authors.affiliation: Department of Medicine, University of California, San Francisco, California.
authors.forename: Deborah
authors.initials: D
authors.lastname: Grady
authors.affiliation: Department of Epidemiology and Biostatistics, University of California, San Francisco, California.
authors.forename: Eric
authors.initials: E
authors.lastname: Vittinghoff
authors.affiliation: Department of Radiology and Biomedical Imaging, University of California, San Francisco, California.
authors.forename: Fergus V
authors.initials: FV
authors.lastname: Coakley
mesh_terms: D000046:Academic Medical Centers; D000328:Adult; D005240:Feasibility Studies; D005260:Female; D057086:High-Intensity Focused Ultrasound Ablation / Q000009:adverse effects; D006801:Humans; D007889:Leiomyoma / Q000473:pathology / Q000601:surgery*; D053783:Magnetic Resonance Imaging, Interventional; D008875:Middle Aged; D010865:Pilot Projects; D011788:Quality of Life; D012008:Recurrence; D012495:San Francisco; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D047368:Tumor Burden; D014594:Uterine Neoplasms / Q000473:pathology / Q000601:surgery*
keywords: MR-guided focused ultrasound; uterine fibroids