title: Outpatient procedure for the treatment and relief of symptomatic uterine myomas.
abstract: OBJECTIVE
  To estimate the safety and efficacy of laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women.
  
  
  METHODS
  A cohort of 135 premenopausal symptomatic women with uterine myomas, uteri 14 weeks of gestation-sized or less with no single myoma exceeding 7 cm, and objectively confirmed heavy menstrual bleeding participated in this prospective, international trial of outpatient laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation. Bleeding outcomes were measured by alkaline hematin analysis at baseline and again at 3, 6, and 12 months posttreatment. Validated quality-of-life and patient satisfaction scales and objective measurements of uterine and myoma volume were conducted at 3, 6, and 12 months.
  
  
  RESULTS
  The mean baseline menstrual blood loss of women in the full analysis set (n=127) was 272.7±82.3 mL. At 3-, 6-, and 12-month follow-ups, mean alkaline hematin and associated menstrual blood loss decreased from baseline levels by 31.8%, 40.7%, and 38.3%, respectively (P<.001, paired t test). Symptom severity decreased from a baseline mean transformed score of 61.1 to 26.6 at 12 months postprocedure (P<.001, paired t test). Health-related quality of life improved from a mean transformed score of 37.3 at baseline to 79.5 at 12 months (P<.001, paired t test). At 12 months postprocedure, total mean myoma volume decreased from baseline by 45.1% (measured by magnetic resonance imaging). There was one serious adverse event (one of 135 [0.7%]) requiring readmission 5 weeks postprocedure and one surgical reintervention for persistent bleeding. Ninety-four percent of the women reported satisfaction with the treatment.
  
  
  CONCLUSIONS
  Radiofrequency volumetric thermal ablation of myomas is well tolerated and results in rapid recovery, high patient satisfaction, improved quality of life, and effective symptom relief.
  
  
  BACKGROUND
  : ClinicalTrials.gov, www.clinicaltrials.gov, NCT00874029.
  
  
  METHODS
  II.
authors: Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, Einstein and Moses Divisions, Albert Einstein College of Medicine, New York, New York; the Department of Obstetrics and Gynecology, Division of Gynecology, Wayne State University School of Medicine, Detroit, Michigan; St John's Mercy Hospital, St. Louis, Missouri; Women's Health Research, Phoenix, Arizona; and the University of Pittsburgh Medical School, Magee-Women's Hospital, Pittsburgh, Pennsylvania.
authors: Scott G
authors: SG
authors: Chudnoff
authors: Jay M
authors: JM
authors: Berman
authors: David J
authors: DJ
authors: Levine
authors: Micah
authors: M
authors: Harris
authors: Richard S
authors: RS
authors: Guido
authors: Erika
authors: E
authors: Banks
mesh_terms: D055011:Ablation Techniques / Q000009:adverse effects / Q000379:methods*; D000328:Adult; D000556:Ambulatory Surgical Procedures; D004598:Electrosurgery / Q000009:adverse effects; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D007889:Leiomyoma / Q000000981:diagnostic imaging / Q000601:surgery*; D008875:Middle Aged; D011446:Prospective Studies; D018084:Ultrasonography, Interventional; D014594:Uterine Neoplasms / Q000000981:diagnostic imaging / Q000601:surgery*
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