Clinical Trial: High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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.


Detailed Summary:
Sponsor: Queen Mary Hospital, Hong Kong

Current Primary Outcome: Perceived symptoms change after HIFU treatment By using the menstrual pain score [ Time Frame: The changes from baseline to post 12-month treatment will be captured ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Perceived symptoms change after HIFU treatment By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL) [ Time Frame: The changes from baseline to post12-month treatment will be captured ]
    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)
  • Efficacy of HIFU in reducing the size of the adenomyotic lesion and the uterus by sonographic measurements. [ Time Frame: The changes from baseline to post 12- month treatment will be captured ]
    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.
  • Discomfort during procedure by using 10-cm visual analogue scale [ Time Frame: immediate after the treatment ]
    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.
  • Patient satisfaction score after HIFU treatment of uterine adenomyosis [ 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- month, 3-month, 6-month and 12- month)
  • Risks and adverse effects of HIFU in the treatment of adenomyosis [ 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- month, 3-month, 6-month and 12- month)
  • Subsequent management after HIFU treatment of uterine adenomyosis [ 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.


Original Secondary Outcome: Same as current

Information By: Queen Mary Hospital, Hong Kong

Dates:
Date Received: October 20, 2016
Date Started: August 2016
Date Completion: December 2019
Last Updated: January 27, 2017
Last Verified: January 2017