Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Fibroid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Efficacy of HIFU in reducing the size of the uterine fibroids by sonographic measurements
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >40 years old, with no future childbearing plans
- •Age >30 years old, who has tubal sterilization
- •Significant fibroids symptoms
- •Clinical uterine size less than 20 weeks gestation
- •Dominant fibroid less than 10 cm in diameter without areas of necrosis as judged by contrast MRI
- •No laparotomy scars
- •Women should be able to give consent
Exclusion Criteria
- •Other pelvic or uncontrolled systemic diseases
- •Confirmed or suspected pregnancy
- •Patients who are contraindicated for MRI examination
- •Patients with thick abdominal wall (>5 cm, as measured by MRI)
- •Presence or history of acute pelvic inflammatory disease
- •History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion
- •Cervical fibroids, subserous or submucous fibroids with pedicle, <3.5 cm posterior wall fibroid, fibroids suspicious of malignancy (rapidly growing)
Arms & Interventions
Treatment arm
HIFU treatment
Intervention: HIFU treatment (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Risks and adverse effects of HIFU in the treatment of uterine fibroid(Up to 12 months)
- Patient satisfaction score after HIFU treatment of uterine fibroid(Up to 12 months)
- Change of perceived symptoms after HIFU treatment by using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)(Up to 12 months)
- Subsequent management after HIFU treatment of uterine fibroid(Up to 12 months)
- Efficacy of HIFU in reducing the size of the uterine fibroids by MRI measurements(The changes from baseline to post 6-month treatment will be captured)
Investigators
Dr. Vincent YT Cheung
Dr
Queen Mary Hospital, Hong Kong