Objective: To compare the long-term results of uterine artery embolisation (UAE) with surgery for women with symptomatic uterine fibroids.
Design: Pragmatic, open, multicentre, randomised trial.
Setting: Twenty-seven participating UK secondary care centres.
Sample: Women aged ≥18 years with symptomatic fibroids who were considered to justify surgical treatment.
Methods: In total, 157 women were randomised (in a 2:1 ratio): 106 to UAE and 51 to surgery (hysterectomy 42; myomectomy nine).
Main outcome measures: Quality of life at 5 years, as assessed by the Short Form General Health Survey (SF-36). Secondary measures included complications, adverse events and the need for further intervention.
Results: There were no significant differences between groups in any of the eight components of the SF-36 scores at 5 years (minimum P = 0.45). Symptom score reduction and patient satisfaction with either treatment was very high, with no group difference. Rates of adverse events were similar in both groups (19% embolization and 25% surgery; P = 0.40). The 5-year intervention rate for treatment failure or complications was 32% (UAE arm) and 4% (surgery arm), respectively. The initial cost benefit of UAE over surgery at 12 months was substantially reduced because of subsequent interventions, with treatments being cost neutral at 5 years.
Conclusions: We have found that UAE is a satisfactory alternative to surgery for fibroids. The less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients. The choice should lie with the informed patient.
© 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.