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Trial registered on ANZCTR


Registration number
ACTRN12622001301752
Ethics application status
Approved
Date submitted
27/09/2022
Date registered
7/10/2022
Date last updated
7/10/2022
Date data sharing statement initially provided
7/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective study of the Safety and Effectiveness of Uterine Artery Embolization for the treatment of Endometriosis (UAE-E) – a Pilot Study
Scientific title
A Prospective study of the Safety and Effectiveness of Uterine Artery Embolization for the treatment of Endometriosis (UAE-E) – a Pilot Study
Secondary ID [1] 308049 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 327741 0
Condition category
Condition code
Reproductive Health and Childbirth 324811 324811 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research project has been designed to provide information on the safety and effectiveness of the Uterine Artery Embolisation (UAE) procedure for the treatment of endometriosis and will be used to determine if a larger study will be undertaken.

Uterine Artery Embolisation (UAE) is accepted in Australia to treat uterine leiomyomas (fibroids). There is also growing literature to support UAE for the treatment of symptomatic adenomyosis (a condition when the tissue that lines the uterus grows into the muscular wall of the uterus). Adenomyosis and endometriosis are both disorders of the endometrial tissue that lines the uterus.

UAE is a procedure where an embolic agent (a gel or glue) is placed in the uterine artery to limit the blood flow to areas of the uterus. It is a minimally invasive procedure performed by an Interventional Radiologist under image guidance. A small incision is made in the groin or the arm and a catheter (a long narrow tube) is placed in the artery and, under image guidance the catheter is directed to the artery to be treated. Once the catheter is in place the embolic agent is placed in the artery and the catheter is removed.

UAE is not approved to treat endometriosis. Therefore, it is an experimental treatment for endometriosis. This means that it must be tested to see if it is an effective treatment for endometriosis.

The procedure will only be done once to participants of this study. Embolisation of uterine arteries (bilateral) using particulate embolic (Boston Scientific Contour PVA Embolization particles). Volume used is dependent on the vessel size, ranging from 3ml-9ml.

The procedure duration will be around 60-90 minutes. The patients will be admitted overnight post procedure for monitoring and further care.

Adherence to the intervention will be done post procedure follow-up and monitoring, and clinical and medical report review.
Intervention code [1] 324497 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332631 0
Safety assessed by the composite number of procedural and post procedural complications as defined by the 2017 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) guidelines.

Risks of Uterine Artery Embolisation

• Hysterectomy
• Non-target embolization
• Contrast agent allergy
Timepoint [1] 332631 0
During procedure, pre-discharge and at six weeks, 3 months, 6 and 12 months through telephone follow-up. Participants should be free from procedural and post procedural complications.

Consultation with the study investigator, recording of SAEs and administration of the BSGE pelvic pain questionnaire will be at 6 weeks, 6 and 12 months post procedure.

Consultation with the referring gynaecology and fertility specialist will be at 3 and 12 months post procedure.

Data will be gathered from the medical procedure notes, follow-up and consultations notes via electronic and paper-based medical record.
Secondary outcome [1] 414156 0
1.Technical success of UAE as defined by visualisation of a significant reduction in perfusion via the uterine artery on angiography at the discretion of the proceduralist. Data will be gathered from the medical procedure notes via electronic medical record.

Timepoint [1] 414156 0
This will be assessed during and immediate after the procedure. Data will be gathered from the medical procedure notes via electronic medical record.
Secondary outcome [2] 414157 0
Any change in pelvic pain at 6 and 12 months as defined by an improvement in the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire.
Timepoint [2] 414157 0
6 and 12 month post procedure through follow-up consultation. Data will be gathered from the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire accomplished and submitted by the participants during follow-up
Secondary outcome [3] 414158 0
Durability of symptom relief at 12 months.
Timepoint [3] 414158 0
12 month post procedure through follow-up consultation. Data will be gathered from the British Society of Gynecologic Endoscopy (BSGE) pelvic pain questionnaire accomplished and submitted by the participants during follow-up

Eligibility
Key inclusion criteria
1. Completed family – no desire for future pregnancies or fertility treatment.
2. Pre-menopausal with regular menstrual periods.
3. Pelvic endometriosis as confirmed by laparoscopy.
4. Symptoms of endometriosis impacting quality of life as evidenced by BSGE pelvic pain questionnaire and including one of the following:
a) period-related pain (dysmenorrhoea) affecting daily activities and quality of life
b) deep pain during or after sexual intercourse
c) period-related or cyclical gastrointestinal symptoms, in particular, painful bowel movements
d) period-related or cyclical urinary symptoms, in particular, blood in the urine or pain passing urine
5. Signed study participant information and consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Desire for future pregnancies or fertility treatment.
2. Perimenopausal by clinical criteria or irregular periods.
3. Previous hysterectomy or previous uterine artery embolisation.
4. Other co-morbidities that are likely to be causing chronic abdominal or pelvic pain.
5. Iodine contrast allergy
6. Active pelvic infection or inflammatory disease
7. Severe renal insufficiency
8. Gynaecological malignancy
9. ECOG 0-1

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Six patients will be recruited for this pilot study. Basic statistics (total numbers and percentages) will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/10/2022
Actual
Date of last participant enrolment
Anticipated
24/10/2023
Actual
Date of last data collection
Anticipated
24/10/2024
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23221 0
The Alfred - Melbourne
Recruitment hospital [2] 23222 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 38588 0
3004 - Melbourne
Recruitment postcode(s) [2] 38589 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 312305 0
Hospital
Name [1] 312305 0
The Alfred Hospital
Country [1] 312305 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commercial Road, Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 313858 0
None
Name [1] 313858 0
Not applicable
Address [1] 313858 0
Not applicable
Country [1] 313858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311674 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 311674 0
55 Commercial Road, Melbourne Victoria 3004
Ethics committee country [1] 311674 0
Australia
Date submitted for ethics approval [1] 311674 0
27/05/2022
Approval date [1] 311674 0
12/09/2022
Ethics approval number [1] 311674 0
226/22

Summary
Brief summary
Uterine Artery Embolisation (UAE) is accepted in Australia to treat uterine leiomyomas (fibroids). There is also growing literature to support UAE for the treatment of symptomatic adenomyosis (a condition when the tissue that lines the uterus grows into the muscular wall of the uterus). Adenomyosis and endometriosis are both disorders of the endometrial tissue that lines the uterus.

UAE is a procedure where an embolic agent (a gel or glue) is placed in the uterine artery to limit the blood flow to areas of the uterus. It is a minimally invasive procedure performed by an Interventional Radiologist under image guidance. A small incision is made in the groin or the arm and a catheter (a long narrow tube) is placed in the artery and, under image guidance the catheter is directed to the artery to be treated. Once the catheter is in place the embolic agent is placed in the artery and the catheter is removed.

UAE is not approved to treat endometriosis. Therefore, it is an experimental treatment for endometriosis. This means that it must be tested to see if it is an effective treatment for endometriosis.

In this trial, the researcher would like validate that embolisation is a safe procedure and will provide improvement in the symptoms of endometriosis for patients with endometriosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121950 0
Dr Jim Koukounaras
Address 121950 0
The Alfred Hospital
55 Commercial Road, Melbourne Victoria 3004
Country 121950 0
Australia
Phone 121950 0
+61 3 90762054
Fax 121950 0
Email 121950 0
j.koukounaras@alfred.org.au
Contact person for public queries
Name 121951 0
Dr Helen Kavnoudias
Address 121951 0
The Alfred Hospital
55 Commercial Road, Melbourne Victoria 3004
Country 121951 0
Australia
Phone 121951 0
+61 3 90762126
Fax 121951 0
Email 121951 0
h.kavnoudias@alfred.org.au
Contact person for scientific queries
Name 121952 0
Dr Helen Kavnoudias
Address 121952 0
The Alfred Hospital
55 Commercial Road, Melbourne Victoria 3004
Country 121952 0
Australia
Phone 121952 0
+61 3 90762126
Fax 121952 0
Email 121952 0
h.kavnoudias@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate data will be available upon request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17195Ethical approval    384723-(Uploaded-27-09-2022-16-09-39)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Prospective Pilot Study of the Safety and Effectiveness of Uterine Artery Embolization for the Treatment of Endometriosis: The UAE-E Study.2023https://dx.doi.org/10.1055/s-0043-1768942
N.B. These documents automatically identified may not have been verified by the study sponsor.