None listed
Conditions
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.
Interventions
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 i
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.
Sponsors
The Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed