High-intensity Focused Ultrasound in Treatment of Uterine Fibroid
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|ClinicalTrials.gov Identifier: NCT02954744|
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : March 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibroids||Procedure: HIFU treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Fibroid|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||March 2018|
Experimental: Treatment arm
Procedure: HIFU treatment
High intensity focused ultrasound
- Efficacy of HIFU in reducing the size of the uterine fibroids by sonographic measurements [ Time Frame: The changes from baseline to post12-month treatment will be captured ]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
- Patient satisfaction score after HIFU treatment of uterine fibroid [ Time Frame: Up to 12 months ]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)
- Change of perceived symptoms after HIFU treatment by using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL) [ Time Frame: Up to 12 months ]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).
- Risks and adverse effects of HIFU in the treatment of uterine fibroid [ Time Frame: Up to 12 months ]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)
- Subsequent management after HIFU treatment of uterine fibroid [ Time Frame: Up to 12 months ]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.
- Efficacy of HIFU in reducing the size of the uterine fibroids by MRI measurements [ Time Frame: The changes from baseline to post 6-month treatment will be captured ]By MRI measurements at baseline, post 6-month, the size of the uterine fibroids will be evaluated by physicians
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954744
|Principal Investigator:||Vincent, YT Cheung, MBBS, FRCOG||Queen Mary Hospital, Hong Kong|