HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids

NCT06692335 | Recruiting DMC

• 1 other identifier: CREC 2024.176
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Fibroids (UF)

Keywords

symptomatic uterine fibroid; Menorrhagia; Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

• Change of quality of life by Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL) from baseline to 3 months after HIFU or myomectomy

  The efficacy of treatment using the Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL), changes from baseline to 3 months post-treatment

  From enrollment to the end of treatment at 3 months

• Change of quality of life by Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL) from baseline to 6 months after HIFU or myomectomy

  The efficacy of treatment using the Uterine Fibroid Symptom health-related Quality of Life questionnaire (UFS-QOL), changes from baseline to 6 months post-treatment

  From enrolment to the end of treatment at 6 months

Secondary Outcomes (10)

• Change of health-related quality of life by Short Form-12 questionnaire (SF-12) from baseline to 3 months after HIFU or myomectomy

  From enrolment to the end of treatment at 3 months

• Change of health-related quality of life by Short Form-12 questionnaire (SF-12) from baseline to 6 months after HIFU or myomectomy

  From enrolment to the end of treatment at 6 months

• Change of Pictorial Blood loss Assessment Chart (PBAC) score from baseline to 3 months after HIFU or myomectomy

  From enrolment to the end of treatment at 3 months

• Change of Pictorial Blood loss Assessment Chart (PBAC) score from baseline to 6 months after HIFU or myomectomy

  From enrolment to the end of treatment at 6 months

• Change of scores by Client Satisfaction questionnaire (CSQ-8) from baseline to 3 months after HIFU or myomectomy

  From enrolment to the end of treatment at 3 months

Study Arms (2)

HIFU group

ACTIVE COMPARATOR

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.

Procedure: High-Intensity Focused Ultrasound (HIFU)

Myomectomy group

PLACEBO COMPARATOR

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.

Procedure: myomectomy

Interventions

High-Intensity Focused Ultrasound (HIFU) PROCEDURE

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.

HIFU group

myomectomy PROCEDURE

Laparoscopic or open or hysteroscopic myomectomy will be performed.

Myomectomy group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Menorrhagia; Dysmenorrhea

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Shing Chee Chan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shing Chee Chan

CONTACT

852-35052803; symphorosa@cuhk.edu.hk

LAI LOI LEE

CONTACT

852-35052583; loretalee@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and Honorary Clinical Professor

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): June 13, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)