High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis

NCT ID: NCT02954757

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-06-30

Brief Summary

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.

Conditions

Adenomyosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

HIFU treatment

Group Type: EXPERIMENTAL

HIFU treatment

Intervention Type: PROCEDURE

High intensity focused ultrasound

Interventions

HIFU treatment

High intensity focused ultrasound

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Vincent YT Cheung

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincent YT Cheung, MBBS, FRCOG

Role: PRINCIPAL_INVESTIGATOR

Queen Mary Hospital, Hong Kong

Locations

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

UW16-283

Identifier Type: -

Identifier Source: org_study_id