Clinical trial NCT02954744: High-intensity Focused Ultrasound in Treatment of Uterine Fibroid
Official title: Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Fibroid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibroids
Keywords: uterine fibroid
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Efficacy of HIFU in reducing the size of the uterine fibroids by sonographic measurements
timeFrame: The changes from baseline to post12-month treatment will be captured
Secondary outcomes:
measure: Patient satisfaction score after HIFU treatment of uterine fibroid
timeFrame: Up to 12 months
measure: Change of perceived symptoms after HIFU treatment by using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)
timeFrame: Up to 12 months
measure: Risks and adverse effects of HIFU in the treatment of uterine fibroid
timeFrame: Up to 12 months
measure: Subsequent management after HIFU treatment of uterine fibroid
timeFrame: Up to 12 months
measure: Efficacy of HIFU in reducing the size of the uterine fibroids by MRI measurements
timeFrame: The changes from baseline to post 6-month treatment will be captured
Other outcomes:
Locations:
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Vincent, YT Cheung, MBBS, FRCOG
role: PRINCIPAL_INVESTIGATOR
References: