A Randomized Controlled Trial of High-Intensity Focused Ultrasound (HIFU) Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
The Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Shing Chee Chan
symphorosa@cuhk.edu.hk
852-35052803
Backup
LAI LOI LEE
loretalee@cuhk.edu.hk
852-35052583
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 112
Treatments
Active_comparator: HIFU group
All women in the HIFU group will undergo pelvic MRI scans, including T1- and T2-weighted imaging, for fibroid localization and treatment planning. 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, with treatment energy tailored to participant feedback and ultrasound imaging.~Post-procedure, participants will be monitored for 4-6 hours, with discharge criteria including dietary tolerance and urination. Data on pain, skin condition, and adverse events will be collected.~Before discharge, participants will complete a Client Satisfaction questionnaire and will receive analgesics, along with instructions to document menstrual cycles using the PBAC chart.
Placebo_comparator: Myomectomy group
Myomectomy will be performed using laparoscopic, open, or hysteroscopic techniques by accredited HKCOG gynecologists.~Key metrics such as blood loss, intraoperative and postoperative complications, whether the endometrial cavity was entered, length of hospital stay, need for blood transfusion, and readmissions will be meticulously recorded. A complete blood count will be assessed approximately 6 hours post-surgery. Patients will be monitored for blood pressure and pulse per departmental protocol.~Typically, those undergoing hysteroscopic myomectomy are discharged the same day, while laparoscopic or open myomectomy patients are discharged within 1 to 3 days.~Before discharge, women will complete a Client Satisfaction questionnaire and will receive analgesics, along with instructions to document their menstrual cycle, flow, and dysmenorrhea using the PBAC chart.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov