High-intensity Focused Ultrasound in Treatment of Uterine Fibroid

NCT02954744 | Completed DMC

• 1 other identifier: UW11-204
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibroids

Keywords

uterine fibroid

Outcome Measures

Primary Outcomes (1)

• Efficacy of HIFU in reducing the size of the uterine fibroids by sonographic measurements

  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

  The changes from baseline to post12-month treatment will be captured

Secondary Outcomes (5)

• 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

• Risks and adverse effects of HIFU in the treatment of uterine fibroid

  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

Study Arms (1)

Treatment arm

EXPERIMENTAL

HIFU treatment

Procedure: HIFU treatment

Interventions

HIFU treatment PROCEDURE

High intensity focused ultrasound

Treatment arm

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Vincent, YT Cheung, MBBS, FRCOG

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: November 3, 2016
• Study Start: March 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 5, 2018

Record last verified: 2018-03