Hysteroscopic Office Myomectomy Evaluation (HOME)

Abstract

Compare safety and effectiveness of a new tissue removal system used by community gynecologists in office and hospital settings. Prospective, randomized, comparative site of treatment study. Eight outpatient private gynecology clinics and hospitals. 41 (100% AUB) patients undergoing hysteroscopic resection of intrauterine fibroids and/or polyps ≤ 3 cm. Mean patient age was 42 years. 34% were nulliparous; 51% had a previous vaginal delivery. The mean pre-treatment Uterine Fibroid Symptom Quality of Life (UFS-QOL, 5 level ordered response, 1 = Not at All to 5 = A Very Great Deal) symptom score was 30. Fibroid/polyp removal using the MyoSure™ Tissue Removal System (6.25 mm diameter hysteroscope and 3.0 mm diameter morcellator) and sterile saline for uterine distension. Women were randomized to undergo treatment in an office setting using a cervical block (61%) or hospital setting using IV sedation (39%). In these 41 women, a total of 23 fibroids (mean diameter 1.9 cm) and 29 polyps (mean diameter 1.4 cm) were removed. There was no difference in clinical outcomes between office and hospital-based treatments. Mean percent pathology removed was 98% per hysteroscopic evaluation. Mean resection time was 3.2 minutes. The cervical block was effective in 100% of office cases with a mean pain score of 2.1 (11-level ordered responses, No Pain = 0 and Worst = 10). Mean physician satisfaction with the device was 4.6 (5-level ordered responses, Very Dissatisfied to Very Satisfied). Of those 24 women that completed 90 day follow up, mean UFS-QOL score was 18, reflecting a 12 point improvement over baseline (p<.0001). There were no SAEs reported throughout 90 day follow-up. The MyoSure™ Tissue Removal System is well tolerated by women and can safely and effectively remove intrauterine fibroids and polyps ≤ 3cm in both office and hospital settings.