Three-month treatment with ulipristal acetate prior to laparoscopic myomectomy of large myomas

Abstract

To assess the usefulness of 3-month therapy with UPA prior to laparoscopic myomectomy (LM) of large uterine myomas. Retrospective analysis of a prospectively collected database. The study included premenopausal women who underwent LM because of myomas with the following characteristics: main myoma FIGO type 3, 4 or 5 with diameter ≥ 10 cm; presence of ≤ 3 myomas; main diameters of the other myomas (FIGO type 3, 4, 5 or 6) ≤ 5 cm and ≤ 3 cm. Patients underwent either direct surgery (group S) or received 3-month preoperative therapy with UPA (5 mg/day orally, Esmya; Gedeon Richter; group UPA). Patients who underwent surgery prior to UPA approval and those who refused preoperative treatment with UPA were included in group S. The pictorial blood-loss assessment chart (PBAC) was used to estimate uterine bleeding. 34 women were included in group UPA and 43 patients in group S. The two groups were similar in demographic characteristics, pretreatment menstrual blood loss and characteristics of the myomas. Prior to treatment with UPA, the two study groups had similar main diameter of the largest myoma, volume of the largest myoma and total myoma volume. In the UPA group, all patients completed the 3-month hormonal treatment. At the end of the 3-month treatment, 70.6% of the patients were amenorrheic; 20.6% of the patients had controlled uterine bleeding (PBAC 28-days score < 75) and 12.5% of the patients had PBAC 28-days score < 100. The 3-month UPA treatment caused a mean (± SD) 31.8% (± 10.9%; 95% C.I., 28.1%-35.5%) decrease in the volume of the largest myoma, a 13.5% (± 5.8%; 95% C.I., 11.6%-15.5%) decrease in the main diameter of the largest myoma, a 31.8% (± 10.7%; 95% C.I., 28.2%-35.4%) decrease in the total myoma volume. Hemoglobin levels significantly increased after UPA treatment (p<0.001). Because of the preoperative treatment with UPA, at surgery, patients included in group UPA had lower diameter of the largest myoma (p<0.001), lower volume of the largest myoma (p=0.020), lower total myoma volume (p=0.015) and higher hemoglobin levels (p<0.001) than patients included in group S. No patient required conversion to laparotomy. The operative time was shorter in group UPA than in group S (p<0.001); the suturing time was similar in the two study groups (p=0.076) . Both the intraoperative blood loss (p=0.012) and the hemoglobin drop (p=0.034) were lower in group UPA than in group S. Six patients in group S and no patient in group UPA required postoperative blood transfusion (p=0.031). The incidence of complications was similar in the two study groups (p=0.726). This study shows that a 3-month preoperative treatment with UPA prior to laparoscopic excision of large uterine myomas decreases the intraoperative blood loss, the hemoglobin drop, the need of postoperative blood transfusion and the length of surgery.