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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
Sponsor:
Information provided by (Responsible Party):
Dr. Vincent YT Cheung, Queen Mary Hospital, Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Fibroids Procedure: HIFU treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment arm
HIFU treatment
 Procedure: HIFU treatment
High intensity focused ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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).

  3. 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)

  4. 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.

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Queen Mary Hospital, Hong Kong
Investigators
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Principal Investigator: Vincent, YT Cheung, MBBS, FRCOG Queen Mary Hospital, Hong Kong
More Information
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Responsible Party: Dr. Vincent YT Cheung, Dr, Queen Mary Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT02954744    
Other Study ID Numbers: UW11-204
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Keywords provided by Dr. Vincent YT Cheung, Queen Mary Hospital, Hong Kong:
uterine fibroid
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases