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Completed

NCT Number: NCT02954744

High-intensity Focused Ultrasound in Treatment of Uterine Fibroid

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.

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Key information

Conditions

Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HIFU treatment

Procedure

High intensity focused ultrasound

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Queen Mary Hospital, Hong Kong

Other

Registry information

Official study title

Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Fibroid

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Nov 3, 2016
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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