Brief Title
High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis
Official Title
Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Adenomyosis
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.
Study Type
Interventional
Primary Outcome
Perceived symptoms change after HIFU treatment By using the menstrual pain score
Secondary Outcome
Perceived symptoms change after HIFU treatment By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)
Condition
Adenomyosis
Intervention
HIFU treatment
Study Arms / Comparison Groups
Treatment arm
Description: HIFU treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
10
Start Date
August 2016
Completion Date
June 2021
Primary Completion Date
March 2021
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
Gender
Female
Ages
30 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Vincent YT Cheung, MBBS, FRCOG, ,
Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT02954757
Organization ID
UW16-283
Responsible Party
Principal Investigator
Study Sponsor
Queen Mary Hospital, Hong Kong
Study Sponsor
Vincent YT Cheung, MBBS, FRCOG, Principal Investigator, Queen Mary Hospital, Hong Kong
Verification Date
September 2020