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.
© 2017 Royal College of Obstetricians and Gynaecologists.