An interventional study of HIFU treatment in Fibroids, sponsored by Queen Mary Hospital, Hong Kong. Completed. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Queen Mary Hospital, Hong Kong · Not applicable, Interventional, and Treatment
Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU) therapy is receiving increasing interest in the management of uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by various research groups have shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of uterine fibroids.
In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study inclusion criteria will be invited to participate in the study which involves the use of HIFU in the management of the fibroid. Background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. Subjects will also be asked to complete an eight-item section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which evaluate the effect of the fibroid on the quality of life of women.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 20 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Queen Mary Hospital, Hong Kong is the lead sponsor of 24 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
HIFU treatment
Procedure: HIFU treatment
High intensity focused ultrasound
Efficacy of HIFU in reducing the size of the uterine fibroids by sonographic measurements
By sonographic measurements at baseline, post 1-month, post 3-month, and post 12-month, the size of the uterine fibroids will be evaluated by physicians
Time frame: The changes from baseline to post12-month treatment will be captured
Patient satisfaction score after HIFU treatment of uterine fibroid
Patients will be asked to give the satisfaction score (0= not satisfactory, 5= very satisfactory) at each follow up (i.e. post treatment 1 months, 3 months, 6 months and 12 months)
Time frame: Up to 12 months
Change of perceived symptoms after HIFU treatment by using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)
By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL) at each follow up (i.e. from baseline to post 1- month, post 1-month to post 3-month, post 3-month to post 6-month, post 6-month to post 12-month treatment will be captured).
Time frame: Up to 12 months
Risks and adverse effects of HIFU in the treatment of uterine fibroid
Patient will be evaluated for abnormal laboratory values and/or adverse events that are related to treatment at each follow up (i.e. post treatment 1 months, 3 months, 6 months and 12 months)
Time frame: Up to 12 months
Subsequent management after HIFU treatment of uterine fibroid
By physician's judgment at each follow up (i.e. at post treatment 1 months, 3 months, 6 months and 12 months), the need for subsequent additional treatments (such as hysterectomy, uterine artery embolization, or any type of hormonal treatment) will be evaluated.
Time frame: Up to 12 months
Efficacy of HIFU in reducing the size of the uterine fibroids by MRI measurements
By MRI measurements at baseline, post 6-month, the size of the uterine fibroids will be evaluated by physicians
Time frame: The changes from baseline to post 6-month treatment will be captured
No study locations are listed for this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Queen Mary Hospital, Hong Kong