Randomized controlled trial of Uterine Artery Embolization versus High-Intensity-Focused-Ultrasound for treatment of patients with uterine fibroids

Last Updated on 23 September, 2011
Sponsor:
Vascular and Interventional Radiology Foundation (www.virf.org)
Department of Imaging and Interventional Radiology, the Chinese University of Hong Kong 

 Study design and purpose

This is a prospective randomized controlled trial that has been approved by the Clinical Research Ethics Committee of the Faculty of Medicine of the Chinese University of Hong Kong. This trial is conducted in accordance to the Declaration of Helsinki and Declaration of Good Clinical Practice (ICH-GCP). Two hundred and sixty patients known to have uterine fibroid will be recruited. This study is aimed to evaluate the clinical effectiveness and adverse effects of HIFU as compared to uterine artery embolization in treating patients with uterine fibroid.

What are the benefits?

The treatment modalities in this study are minimally invasive (embolization) or non-invasive (HIFU) in nature. Study subjects in the current study will be treated with these active interventions as an alternative to the more invasive surgical intervention. If the treatment is found useful for the patient, subsequent treatment will be provided to the study subjects free of charge.

Eligibility criteria

In general, patient who has uterine fibroid and clinically requires surgical intervention but patient would like to consider alternative active interventions to surgery or has medical contraindication against surgery will be recruited. Specifically, the inclusion criteria are:

  1. Female gender
  2. Age between 30 and 47
  3. Pre or peri menopausal
  4. Weight less than 140kg (or 310lbs) and BMI less than 33
  5. Cervical cytology no more severe than low grade SIL
  6. Negative urine pregnancy test
  7. Uterine size less than 24 weeks based on physical exam assessment
  8. History of uterine leiomyoma causing symptoms of bleeding, urinary frequency, pelvic or lower abdominal discomfot or pain.
  9. Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 12 cm on imaging.
  10. Excellent health other than history of leiomyomas.
  11. No future fertility wish.
  12. Willing and able to give informed consent.
  13. Willing and able to comply with study requirements.

Study location
Prince of Wales Hospital

Principal investigators
Professor Simon Chun-Ho Yu
Professor Anil Ahuja