Uterine fibroids (leiomyoma) Cancer Leiomyoma of uterus, unspecified
Conditions
Interventions
Uterine artery embolisation performed using either:
1. Contour Non-spherical polyvinyl alcohol (PVA), Boston Scientific, USA. CE 0197
OR
2. Embozene M
Sponsors
St George's Healthcare NHS Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Symptomatic fibroids admitted for uterine artery embolisation 2. Female participants aged 18-55 years
Exclusion criteria
Exclusion criteria: 1. Recent or ongoing pelvic inflammatory disease 2. Severe radiographic contrast medium allergy. 3. Significant adenomyosis, as identified by transvaginal ultrasound or MRI. Concurrent adenomyosis where fibroids are believed to the predominant cause of symptoms will be eligible. 4. Positive pregnancy test 5. Refusal to accept hysterectomy, in the event of an intra-operative complication. 6. Suspected malignancy 7. Age< 18 8. Unable to provide informed consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity (Scotland) Act 2000. 9. A non English speaker where translation or interpretation facilities are insufficient to guarantee informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To confirm whether microsphere embolic particles (Embozenes) improve patient?s quality of life compared with the standard agent of non-spherical PVA (Contour PVA). This is measured using the validated Uterine Fibroid Symptom and Health-related Quality of Life questionnaire (UFS-QOL). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Contrast-enhanced MRI performed before and 6 months after UAE 2. Percentage Fibroid infarction - total fibroid burden and dominant fibroid infarction 3. Uterine and dominant fibroid volume reductions | — |
Countries
England, United Kingdom
Outcome results
None listed