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Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids

Phase 1
30 Years
47 Years
Open (Enrolling)
Uterine Fibroids

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Trial Information

Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids

The usual management for symptomatic uterine fibroid is surgery (myomectomy or
hysterectomy), in the current study, uterine artery embolization (UAE) is a form of
non-surgical and minimally invasive treatment, High-Intensity-Focused-Ultrasound (HIFU) is a
form of non-invasive treatment that can be completed as an out-patient within hours.
Embolization causes ischaemia and shrinkage of the fibroid and therefore symptomatic
relieve. HIFU is a medical technology that has been used for cancer treatment. Energy is
delivered from outside the body in a non-invasive manner to produce heat energy that causes
necrosis and shrinkage of the uterine fibroid thereby relieves the symptoms due to the
fibroid. It does not involve radiation. The clinical effectiveness of HIFU for uterine
fibroid is unknown, however, based on the knowledge of the clinical effectiveness of HIFU on
liver cancer and pancreatic cancer, there is reasonable ground to believe that HIFU is
effective for uterine fibroid.

Inclusion Criteria:

- Female gender

- Age between 30 and 47

- Pre or peri menopausal with FSH less than 40 mIU/ml

- Weight less than 140kg (or 310lbs) and BMI less than 33

- Cervical cytology no more severe than low grade SIL

- Negative urine pregnancy test

- Uterine size less than 24 weeks based on physical exam assessment

- History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain.
Excessive uterine bleeding will be evidenced by either one of the following-profuse
bleeding with flooding or clots or repetitive periods lasting for more than 8 days;
or anemia due to acute or chronic blood loss OR pelvic discomfort caused by
leiomyomata, either acute and severe or chronic lower abdominal or low back pressure
or bladder pressure with urinary frequency not due to urinary tract infection

- Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to
12 cm on imaging.

- Good health other than history of leiomyomas. Chronic medications may be acceptable
at the discretion of the research team.

- No future fertility wish.

- Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of
contraception and are willing to continue using them throughout the study.

- Willing and able to give informed consent.

- Willing and able to comply with study requirements.

- Normal menstrual cycle with endometrial pathology excluded

- Normal renal function

- Normal liver function

- Platelet count greater than 50 K/microL

- Normal coagulation profile

Exclusion Criteria:

- Significant abnormalities in the history, physical or laboratory examination

- History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus,

- Other pelvic mass indicated by history or MR imaging such as endometriosis, ovarian
tumor, acute or chronic pelvic inflammatory disease

- Desire for future pregnancy

- Pregnant or Positive pregnancy test

- Lactation

- Unexplained vaginal bleeding

- Untreated severe cervical dysplasia

- Intrauterine device

- Need for interval use of narcotics

- Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or
scar tissue or surgical clips in the direct path of the HIFU

- Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than
25% of the maximal fibroid diameter.

- Genetic causes of leiomyomata

- Known recent rapid growth of fibroids, defined as a doubling in size in 6 months

- Patient unwilling to receive non-surgical treatment

- Contraindication to MRI due to severe claustrophobia or implanted metallic device.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment success rate

Outcome Description:

Technical success of treatment procedure and absence of symptoms of fibroid

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Simon CH Yu, MD, FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong


Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:




Start Date:

May 2009

Completion Date:

Related Keywords:

  • Uterine Fibroids
  • Leiomyoma
  • Myofibroma