title: Laparoscopic radiofrequency fibroid ablation: phase II and phase III results.
abstract: OBJECTIVE
  To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA).
  
  
  METHODS
  We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasound-guided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied.
  
  
  RESULTS
  From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P < .001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P < .001) (n = 57), and mean uterine volume decreased from 204.4 cm(3) to 151.4 cm(3) (P = .008) (n = 58). Patients missed a median of 4 days of work (range, 2-10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related quality-of-life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1-29 days). The rate of periprocedural device-related adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment.
  
  
  CONCLUSIONS
  RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.
authors: San Ramon Ob/Gyn, 11030 Bollinger Canyon Rd, Ste 250, San Ramon, CA 94582, USA. drgalen@drgalen.com.
authors: Donald I
authors: DI
authors: Galen
authors: Department of Obstetrics and Gynecology, Hospital Universitario Esperanza, Guatemala City, Guatemala.
authors: Rodolfo Robles
authors: RR
authors: Pemueller
authors: Department of Gynecology and Obstetrics, Hospital Universitario de Nuevo Leon, Monterrey, Mexico.
authors: José Gerardo Garza
authors: JG
authors: Leal
authors: Athena Gynecology Medical Group, Reno, NV, USA.
authors: Karen R
authors: KR
authors: Abbott
authors: Montefiore Medical Center-Einstein Division, Bronx, NY, USA.
authors: Janice L
authors: JL
authors: Falls
authors: Pasadena Premier Women's Health, Pasadena, CA, USA.
authors: James
authors: J
authors: Macer
mesh_terms: D000328:Adult; D017115:Catheter Ablation; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D010535:Laparoscopy; D007889:Leiomyoma / Q000000981:diagnostic imaging / Q000601:surgery*; D008875:Middle Aged; D011247:Pregnancy; D018873:Pregnancy Rate; D011788:Quality of Life; D012189:Retrospective Studies; D018582:Sick Leave; D018084:Ultrasonography, Interventional; D014594:Uterine Neoplasms / Q000000981:diagnostic imaging / Q000601:surgery*