High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis

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

Uterine adenomyosis is a common uterine benign condition. They can cause abnormal menstrual bleeding, and menstrual pain. 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 adenomyosis 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 adenomyosis.

In this proposed study, 10 patients who have symptomatic uterine adenomyosis 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 adenomyosis. 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) and menstrual pain score which evaluate the effect of the adenomyosis on the quality of life of women.

Study Overview

• Status: Unknown
• Conditions: Adenomyosis
• Intervention / Treatment: Procedure: HIFU treatment

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age >40 years old, with no future childbearing plans
• Age >30 years old, who has tubal sterilization
• Significant symptoms related to adenomyosis, intractable to standard medical therapy, or patient considering radiological intervention (uterine fibroid embolization) or surgery.
• Clinical uterine size less than 20 weeks gestation
• Localized adenomyotic lesion or adenomyoma identified of less than 10 cm in diameter as judged by contrast MRI, involving only anterior or posterior uterine wall and not both.
• 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 unable to communicate with researchers during the treatment
• 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 or any pelvic malignancy
• History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion
• Presence of significant sized fibroids which may interfere with the treatment or affect the outcome measures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; HIFU treatment	Procedure: HIFU treatment; High intensity focused ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived symptoms change after HIFU treatment By using the menstrual pain score	By using the menstrual pain score for pain evaluation 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).	The changes from baseline to post 12-month treatment will be captured

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived symptoms change after HIFU treatment By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)	By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL) for symptoms evaluation 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)	The changes from baseline to post12-month treatment will be captured
Efficacy of HIFU in reducing the size of the adenomyotic lesion and the uterus by sonographic measurements.	By sonographic measurements at baseline, post 1-month, post 3-month and post 12-month treatment, the size of the adenomyotic lesion and the uterus will be evaluated by physicians.	The changes from baseline to post 12- month treatment will be captured
Discomfort during procedure by using 10-cm visual analogue scale	By using 10-cm visual analogue scales (0 = no pain, 10 = worst pain). Women will be asked to give the pain score immediately after the HIFU treatment.	immediate after the treatment
Patient satisfaction score after HIFU treatment of uterine adenomyosis	Patients will be asked to give the satisfaction score (0= not satisfactory, 5= very satisfactory) at each follow up (i.e. post treatment 1- month, 3-month, 6-month and 12- month)	Up to 12 months
Risks and adverse effects of HIFU in the treatment of adenomyosis	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- month, 3-month, 6-month and 12- month)	Up to 12 months
Subsequent management after HIFU treatment of uterine adenomyosis	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Queen Mary Hospital, Hong Kong
• Investigators: Principal Investigator: Vincent YT Cheung, MBBS, FRCOG, Queen Mary Hospital, Hong Kong

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimate): November 3, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: uterine adenomyosis
• Additional Relevant MeSH Terms: Uterine Diseases; Adenomyosis
• Other Study ID Numbers: UW16-283