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• W2126473256 abstract "This study is designed to demonstrate whether or not Bead Block™ (BB) is as effective an agent for Uterine Artery Embolization (UAE) as Embosphere™ (ES). Patients were prospectively randomized to UAE using BB or ES. Patients were not informed of which material was used for their embolization. All embolizations were performed by a single operator with extensive UAE experience, to the same defined endpoint. Particle size was selected according to the best available current protocols for the two agents. Contrast-enhanced pelvic MRIs were obtained before the procedure (baseline), within 7 days of the procedure, at 3 months post-procedure, and at 6 months post-procedure. Fibroid perfusion was scored by an independent reader who was blinded to the embolic agent used (study is double-blind). UFS-QOL scores are collected at baseline and again 3, 6, and 12 months post-procedure. Clinical follow-up is at 2 weeks post procedure and again at 1, 3, 6, and 12 months post procedure. The study protocol calls for 44 patients to achieve appropriate statistical power as a non-inferiority comparison of the two agents. To date 22 patients have been treated, and follow-up is complete to the 6-month point for those 22 patients. 10 patients have been treated with ES, and 12 with BB. There has been 1 technical failure (patient with unilateral agenesis of the uterine artery). There have been no significant complications. All patients have had either complete (ES group 9/10, BB group 12/12) or almost complete (ES group 1/10, BB group 0/12) infarction. All patients have had essentially complete resolution of symptoms with improvement in QOL scores (Symptoms, Overall QOL, and Subscales) averaging > 40 points from baseline in both groups. There is no significant difference between the two groups in terms of symptom relief. Current statistical analysis indicates that the current data supports the noninferiority hypothesis that BB is equally effective as an embolic agent for UAE compared to ES at the p=.05 (α=80%) level. Completion of the study with enrollment and treatment of another 22 patients over the next 6-12 months is planned." @default.
• W2126473256 created "2016-06-24" @default.
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• W2126473256 date "2008-02-01" @default.
• W2126473256 modified "2023-10-17" @default.
• W2126473256 title "Abstract No. 147: Randomized Trial of Bead Block™ vs Embosphere™ for Uterine Artery Embolization for Fibroid Disease – Interim Results" @default.
• W2126473256 doi "https://doi.org/10.1016/j.jvir.2007.12.163" @default.
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