HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids
A Randomized Controlled Trial of High-Intensity Focused Ultrasound (HIFU) Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids
Chinese University of Hong Kong
112 participants
Feb 6, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if High-Intensity Focused Ultrasound (HIFU) is as effective as myomectomy for treating symptomatic uterine fibroids in women aged 18 to 50. The main questions it aims to answer are: Is HIFU as effective as myomectomy in improving quality of life for women with uterine fibroids? How do the recovery times and complications compare between HIFU and myomectomy? Researchers will compare the outcomes of women receiving HIFU treatment to those undergoing myomectomy to see if HIFU offers similar or better results with fewer complications. Participants will: Undergo an initial medical assessment, including ultrasounds and blood tests. Receive either HIFU treatment or myomectomy based on random assignment. Complete questionnaires about their symptoms and quality of life before treatment and at follow-up visits (3 and 6 months post-treatment). Be monitored for any complications and recovery progress during follow-up.
Eligibility
Inclusion Criteria7
- Age 18 - 50 years-old
- Pre or peri menopausal with FSH less than 25 mIU/ml
- BMI \< 33 kg/m2 or abdominal wall thickness \< 5 cm
- Uterine size ≤18 weeks based on physical exam assessment
- Dominant intramural fibroid ≥ 3cm and ≤ 10cm on imaging
- Symptomatic fibroids cause menorrhagia, pressure, or pelvic pain
- Willing and able to give informed consent
Exclusion Criteria14
- Patient with other pelvic mass indicated by history or magnetic resonance imaging (MRI) such as endometriosis, abnormal adnexal mass, ovarian tumor, acute or chronic pelvic inflammatory disease
- Morbid obesity
- Inability to lie in a prone position for more than 2 hours
- Extensive abdominal scar on the acoustic channel
- Women with pregnancy, lactation or menopause
- Uterine premalignant or malignant pathologies or pathology other than uterine fibroid cannot be ruled out through detailed clinical assessment and investigation including MRI
- Rapid growth of fibroids, defined as a doubling in size in 6 months
- History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
- Coagulation problem or using medication which affect clotting function
- History of pelvic irradiation
- Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than 25% of the maximal fibroid diameter
- Cervical/ broad ligament fibroid
- Contraindication to MRI due to severe claustrophobia or implanted metallic device.
- Co-existing adenomyosis
Interventions
The HIFU treatment will utilize the Haifu JC 200 system under real-time ultrasound guidance, with participants positioned prone in a water-filled generator chamber. Conscious sedation will be administered using fentanyl and midazolam, adjusted based on pain tolerance. Acoustic output power will range from 300 to 400W.
Laparoscopic or open or hysteroscopic myomectomy will be performed.
Locations(1)
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NCT06692335