AdenomyosisNCT02954757
High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis
A study testing HIFU treatment in people with Adenomyosis, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- HIFU treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2016to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Adenomyosis
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
- Being tested
- HIFU treatment
- Keywords
- uterine adenomyosis
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU treatmentProcedure or surgery
High intensity focused ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | HIFU treatment Receives: Procedure: HIFU treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived symptoms change after HIFU treatment By using the menstrual pain score
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).
Measured: The changes from baseline to post 12-month treatment will be captured
Secondary outcomes (6)
Perceived symptoms change after HIFU treatment By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL)
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)
Measured: The changes from baseline to post12-month treatment will be captured
Efficacy of HIFU in reducing the size of the adenomyotic lesion and the uterus by sonographic measurements.
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.
Measured: The changes from baseline to post 12- month treatment will be captured
Discomfort during procedure by using 10-cm visual analogue scale
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.
Measured: immediate after the treatment
Patient satisfaction score after HIFU treatment of uterine adenomyosis
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)
Measured: Up to 12 months
Risks and adverse effects of HIFU in the treatment of adenomyosis
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)
Measured: Up to 12 months
Subsequent management after HIFU treatment of uterine adenomyosis
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vincent YT Cheung, Queen Mary Hospital, Hong Kong
- Investigators
- Vincent YT Cheung, MBBS, FRCOG, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954757
- Sponsor's protocol ID
- UW16-283
- Status last verified
- Sep 2020
- First submitted
- 20 Oct 2016
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Adenomyosis
- ClinicalTrials.gov ID
- NCT02954757
- Acronym / sponsor ID
- UW16-283
- Conditions
- Adenomyosis
- Keywords
- uterine adenomyosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Procedure: HIFU treatmentHIFU treatment |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFU treatmentHigh intensity focused ultrasound | Procedure or surgery | Treatment arm |
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).
6 secondary outcomes
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
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
Discomfort during procedure by using 10-cm visual analogue scale
Time frame: immediate after the treatment
Patient satisfaction score after HIFU treatment of uterine adenomyosis
Time frame: Up to 12 months
Risks and adverse effects of HIFU in the treatment of adenomyosis
Time frame: Up to 12 months
Subsequent management after HIFU treatment of uterine adenomyosis
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent YT Cheung, MBBS, FRCOG principal investigator
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU treatment in people with Adenomyosis, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.