A Prospective study of the Safety and Effectiveness of Uterine Artery Embolization for the treatment of Endometriosis (UAE-E) – a Pilot Study

Not Applicable

• Conditions: Endometriosis; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12622001301752
• Lead Sponsor: The Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-07
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 6

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>Risks of Uterine Artery Embolisation<br><br>• Hysterectomy<br>• Non-target embolization<br>• Contrast agent allergy<br>[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. <br><br>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.<br><br>Consultation with the referring gynaecology and fertility specialist will be at 3 and 12 months post procedure. <br><br>Data will be gathered from the medical procedure notes, follow-up and consultations notes via electronic and paper-based medical record. ]