HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids

Launched by CHINESE UNIVERSITY OF HONG KONG · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for women aged 18 to 50 who have symptomatic uterine fibroids, which are non-cancerous growths in the uterus that can cause issues like heavy bleeding and pelvic pain. The trial compares High-Intensity Focused Ultrasound (HIFU), a non-invasive treatment that uses sound waves to target fibroids, to myomectomy, a surgical procedure that removes the fibroids. Researchers want to find out if HIFU is just as effective as myomectomy in improving the quality of life for these women, as well as how the recovery times and potential complications of each treatment compare.

To participate in the trial, women need to be pre-menopausal and meet certain health criteria, including a body mass index (BMI) under 33 and specific size requirements for their fibroids. Participants will start with a medical assessment, then be randomly assigned to receive either HIFU or myomectomy. Throughout the trial, they will fill out questionnaires about their symptoms and well-being, and their recovery will be monitored for any complications. This study is currently recruiting participants and aims to provide valuable information about the best treatment options for symptomatic uterine fibroids.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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