High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis

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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