Abstract
The aim of the study is to evaluate the feasibility, tolerability, and clinical outcomes of uterine artery embolization (UAE) using gelfoam (G) alone versus embospheres + gelfoam (E + G) in women with symptomatic uterine fibroids. Prospective, patient blinded, randomized controlled pilot study (Level-I). University Affiliated Teaching Hospital. Fifty-nine women with symptomatic uterine fibroids; G (n = 31) vs. E + G (n = 28). Fluoroscopy-guided trans-femoral artery UAE was performed under intravenous sedation, local anesthesia, and overnight patient-controlled analgesia (PCA) pump using either gelfoam pledgets alone or gelfoam plus embospheres (500-700 mu m). Baseline, 3, 6, and 12 month dominant fibroid and total uterine volume as well as menstrual blood loss and satisfaction scores were compared between the groups. The mean and standard deviation (SD) of uterine volume (cm(3)) for G vs G + E at baseline and at 3, 6, and 12 months were 801 (538) vs.565 (370), 535 (226) vs. 426 (322), 485 (401) vs. 401 (249), and 467 (438) vs. 343 (227), while the mean (SD) of the dominant fibroid volume (cm(3)) during the same time periods were 268 (291) vs. 227 (213), 190 (290) vs. 137 (168), 132 (168) vs. 93 (101), and 118 (169) vs. 81 (99), respectively, with no statistical difference (NS) between the two groups at any interval. The corresponding mean (SD) Ruta scores assessing uterine blood loss at the same time periods were 19.2 (6.8) vs. 21.6 (6.1, NS), 11.5 (7.2) vs. 8.1 (5.2, NS), 13.2 (8.3) vs. 6.4 (4.0, p < 0.001), and 10.5 (7.9) vs. 5.8 (3.6, p < 0.01) for G-alone and E + G, respectively. At 12 months, 71 vs. 79 % of patients were satisfied/very satisfied with their treatment (NS). UAE with gelfoam alone was feasible, tolerable, and equally effective to embospheres + gelfoam in reducing uterine and fibroid volume while it normalized menstrual blood loss.