Evaluation of high-intensity focused ultrasound ablation for uterine fibroids: an IDEAL prospective exploration study

BJOG. 2018 Feb;125(3):354-364. doi: 10.1111/1471-0528.14689. Epub 2017 Jun 5.


Objective: To evaluate the clinical outcomes of high-intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial.

Design: Prospective multicentre patient choice cohort study (IDEAL Exploratory study) of HIFU, myomectomy or hysterectomy for treating symptomatic uterine fibroids.

Setting: 20 Chinese hospitals.

Population or sample: 2411 Chinese women with symptomatic fibroids.

Methods: Prospective non-randomised cohort study with learning curve analysis (IDEAL Stage 2b Prospective Exploration Study).

Main outcome measures: Complications, hospital stay, return to normal activities, and quality of life (measured with UFS-Qol and SF-36 at baseline, 6 and 12 months), and need for further treatment. Quality-of-life outcomes were adjusted using regression modelling. HIFU treatment quality was evaluated using LC-CUSUM to identify operator learning curves. A health economic analysis of costs was performed.

Results: 1353 women received HIFU, 472 hysterectomy and 586 myomectomy. HIFU patients were significantly younger (P < 0.001), slimmer (P < 0.001), better educated (P < 0.001), and wealthier (P = 0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (P = 0.002 and P = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (P < 0.001). Median time for hospital stay was 4 days (interquartile range, 0-5 days), 10 days (interquartile range, 8-12.5 days) and 8 days (interquartile range, 7-10 days).

Conclusions: HIFU caused substantially less morbidity than surgery, with similar longer-term QoL. Despite group baseline differences and lack of blinding, these findings support the need for a randomised controlled trial (RCT) of HIFU treatment for fibroids. The IDEAL Exploratory design facilitated RCT protocol development.

Tweetable abstract: HIFU had much better short-term outcomes than surgery for fibroids in 2411-patient Chinese IDEAL format study.

Keywords: Fibroid; learning curve; trial methodology; ultrasound.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • China / epidemiology
  • Cohort Studies
  • Female
  • High-Intensity Focused Ultrasound Ablation* / adverse effects
  • High-Intensity Focused Ultrasound Ablation* / methods
  • High-Intensity Focused Ultrasound Ablation* / statistics & numerical data
  • Humans
  • Hysterectomy* / adverse effects
  • Hysterectomy* / methods
  • Hysterectomy* / statistics & numerical data
  • Leiomyoma* / epidemiology
  • Leiomyoma* / pathology
  • Leiomyoma* / psychology
  • Leiomyoma* / therapy
  • Length of Stay / statistics & numerical data
  • Middle Aged
  • Outcome and Process Assessment, Health Care
  • Postoperative Complications* / epidemiology
  • Postoperative Complications* / etiology
  • Prospective Studies
  • Quality of Life*
  • Recovery of Function
  • Uterine Myomectomy* / adverse effects
  • Uterine Myomectomy* / methods
  • Uterine Myomectomy* / statistics & numerical data
  • Uterine Neoplasms* / epidemiology
  • Uterine Neoplasms* / pathology
  • Uterine Neoplasms* / psychology
  • Uterine Neoplasms* / therapy