HIFU Versus Myomectomy for the Treatment of Symptomatic Uterine Fibroids
ConditionUterine Fibroids (UF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorChinese University of Hong Kong
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
High-Intensity Focused Ultrasound (HIFU)
Procedure/SurgeryThe 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.
myomectomy
Procedure/SurgeryLaparoscopic or open or hysteroscopic myomectomy will be performed.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: HIFU groupActive comparator 1 intervention
Group B: Myomectomy groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From enrollment to the end of treatment at 3 months2
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
Time frame
From enrolment to the end of treatment at 6 monthsSecondary outcomes
1
Change of health-related quality of life by Short Form-12 questionnaire (SF-12) from baseline to 3 months after HIFU or myomectomy
The efficacy of treatment in health-related quality of life by Short Form-12 questionnaire (SF-12), changes from baseline to 3 months
Time frame
From enrolment to the end of treatment at 3 months2
Change of health-related quality of life by Short Form-12 questionnaire (SF-12) from baseline to 6 months after HIFU or myomectomy
The efficacy of treatment in health-related quality of life by Short Form-12 questionnaire (SF-12), changes from baseline to 6 months
Time frame
From enrolment to the end of treatment at 6 months3
Change of Pictorial Blood loss Assessment Chart (PBAC) score from baseline to 3 months after HIFU or myomectomy
The efficacy of treatment in PBAC score, changes from baseline to 3 months post-treatment
Time frame
From enrolment to the end of treatment at 3 months4
Change of Pictorial Blood loss Assessment Chart (PBAC) score from baseline to 6 months after HIFU or myomectomy
The efficacy of treatment in PBAC score, changes from baseline to 6 months post-treatment
Time frame
From enrolment to the end of treatment at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov