Abstract
BackgroundUterine artery embolisation (UAE) is an established treatment option for women with symptomatic uterine fibroids who wish to avoid surgery. However the most efficacious embolic agent remains uncertain.MethodsWe conducted a pilot double blind randomized controlled trial comparing Gelfoam with Embospheres in women undergoing UAE. Outcomes recorded at baseline, 24-h, 1 and 6 months included complications, inflammatory, haematological markers and ovarian function. Contrast enhanced MRI (CEMRI) was acquired at baseline, 24-h and 6 months. Pain score (visual analogue) was measured at 24-h, quality of life (UFS-Qol) at baseline, 1 and 6 months. All patients were followed to 6 months.ResultsTwenty patients were randomized 1:1 to receive either Gelfoam (G) or Embospheres (E). The UFS-Qol symptom score improved in both groups at 6 months mean of 64 ± 18 to 23 ± 16 and 54 ± 15 to 32 ± 26 in the E and G groups respectively. UFS-Qol HRQL also improved in both groups at 6 months, mean 41 ± 28 to 79 ± 20 and 53 ± 19 to 78 ± 21 in the E and G groups respectively.Uterine volume at 6 months reduced from 1018 ± 666mls to 622 ± 436 (p = 0.001) and from 1026 ± 756 to 908 ± 720 (p = 0.15) in the E and G groups respectively. There was a significant difference between groups for this parameter p = 0.01. All uterine arteries were patent at 24-h and 6 months. Complete (100%) fibroid infarction rates were 5(50%) and 2(20%) in the E and G groups respectively. None of the other outcome measures showed any between group differences. There were no re-interventions in either group.ConclusionThe only significant between group differences was for a greater reduction in uterine volume at 6 months in the E group. A larger trial (estimate 172 subjects) is required to determine whether other apparent differences are clinically and statistically significant.Trial registrationISRCTN67347987
Highlights
IntroductionWhen symptomatic Uterine artery embolisation (UAE) is an established treatment option for those who wish to avoid conventional surgery (Edwards et al, 2007; Moss et al, 2011)
Uterine fibroids are the most common tumour in women (Wilcox et al, 1994)
Livingston, Scotland) and more permanent options such as Polyvinyl alcohol (PVA) particles ((Contour, Boston Scientific, Hemel Hempstead, UK; PVA (Cook Medical, Bloomington, IN, USA)), Trisacrylgelatin microsphere (Embospheres, Merit Medical Ltd., Coatbridge, Scotland), PVA hydrogel beads with acrylic polymer (Beadblock, Terumo UK Ltd., Surrey, UK.), HydroPearl microspheres (Terumo UK Ltd., Surrey UK) and Hydrogel microspheres coated with Polyzene-F (Embozene, Celonova BioSciences, Basingstoke, UK)
Summary
When symptomatic UAE is an established treatment option for those who wish to avoid conventional surgery (Edwards et al, 2007; Moss et al, 2011). In theory at least it should be suitable for fibroids and Japanese workers have demonstrated its efficacy reporting cumulative rates of symptom control of 96.9% at 1 year, 89.5% at 3 years, and 89.5% at 5 years respectively (Das et al, 2014). In spite of this Gelfoam has not gained widespread acceptance for fibroid embolisation. Uterine artery embolisation (UAE) is an established treatment option for women with symptomatic uterine fibroids who wish to avoid surgery.
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