Prospective Evaluation of the Embolic Agent Bead Block in the Treatment of Uterine Leiomyomas with Uterine Artery Embolization: A Phase II Study

Purpose: To assess symptom reduction and follow-up magnetic resonance (MR) imaging findings in patients who have undergone uterine artery embolization (UAE) for symptomatic leiomyomas with the use of Bead Block. Materials and Methods: Symptomatic patients with uterine leiomyomas were treated with UAE with Bead Block. Degree of tumor infarction was assessed 3 months after treatment with contrast material-enhanced MR imaging. Each case was categorized as showing less than 25% infarction, 25%-89% infarction, or at least 90% infarction. Imaging-based failure was defined as tumor infarction of less than 90% (12). Symptom and quality status were determined by scores from symptom and quality of life (QOL) and health-related QOL questionnaires collected 1 and 3 months after embolization. Results: This prospective trial enrolled 23 patients. Three-month follow-up MR imaging was completed in 22 patients. Tumor necrosis of 90% or greater occurred in 10 of 22 patients (45%), and 12 (54%) had partial necrosis of 25%-89%. The QOL subscale evaluation showed significant reduction of symptom severity from baseline to 1 month after treatment (P < .0001), with no significant difference between 1 and 3 months of follow-up (P = .42). Because of the unacceptably high imaging failure rate of 54%, enrollment was terminated before the anticipated 30-patient goal. Conclusions: The use of Bead Block in the manner described resulted in significant clinical improvement. However, there was an unacceptably high rate of imaging failure under the existing protocol. Modification of the existing protocol should be considered.