Clinical trial NCT02954757: High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis
Official title: Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Adenomyosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenomyosis
Keywords: uterine adenomyosis
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 10
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Perceived symptoms change after HIFU treatment By using the menstrual pain score
timeFrame: The changes from baseline to post 12-month treatment will be captured
Secondary outcomes:
measure: Perceived symptoms change after HIFU treatment By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)
timeFrame: The changes from baseline to post12-month treatment will be captured
measure: Efficacy of HIFU in reducing the size of the adenomyotic lesion and the uterus by sonographic measurements.
timeFrame: The changes from baseline to post 12- month treatment will be captured
measure: Discomfort during procedure by using 10-cm visual analogue scale
timeFrame: immediate after the treatment
measure: Patient satisfaction score after HIFU treatment of uterine adenomyosis
timeFrame: Up to 12 months
measure: Risks and adverse effects of HIFU in the treatment of adenomyosis
timeFrame: Up to 12 months
measure: Subsequent management after HIFU treatment of uterine adenomyosis
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
Study officials:
affiliation: Queen Mary Hospital, Hong Kong
name: Vincent YT Cheung, MBBS, FRCOG
role: PRINCIPAL_INVESTIGATOR
References: