Robert J Rubino1, Andrea S Lukes2. 1. Rubino OBGYN Group, West Orange, New Jersey. Electronic address: Rubinoobgyn@yahoo.com. 2. Carolina Women's Research and Wellness Center, Durham, North Carolina.
Abstract
STUDY OBJECTIVE: To examine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure. DESIGN: Randomized, prospective, comparative setting clinical trial (Canadian Task Force classification II-2). SETTING:Nine outpatient obstetrics and gynecology practices and hospitals in the United States. PATIENTS: Women 18 to 55 years of age with polyps and/or type 0 or I myomas ≥1.5 and ≤3.0 cm. INTERVENTIONS: Treatment of polyps and fibroids with the MyoSure device. MEASUREMENTS AND MAIN RESULTS:A total of 118 lesions (76 polyps, 42 myomas) were removed. Among the 118 pathologies removed, 53 were removed in an office setting (28 myomas, 25 polyps), and 55 were removed in an ambulatory surgical center (ASC) setting (14 myomas, 41 polyps). The mean percentage of pathology removed was 95.9 ± 6.8% for fibroids and 99.9 ± 0.7% for polyps. Symptom severity as measured by the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scale improved significantly (p < .01) between baseline (mean score of 67.5 ± 15.4) and 12 months postprocedure (mean score of 22.3 ± 22.6). The Health-Related Quality of Life (HRQOL) scale also improved significantly (p < .01) between baseline (mean score 38.7 ± 23.3) and 12 months postprocedure (mean score of 83.9 ± 24.4). Both the office and ASC groups demonstrated a statistically significant (p < .01) improvement in UFS-QOL and HRQOL. CONCLUSION: For women with intrauterine polyps and/or myomas who experienced abnormal uterine bleeding, hysteroscopic morcellation with the MyoSure device provided significant, durable health-related, quality-of-life improvements up to 12 months postprocedure. These findings were the same for patients treated in both an office-based setting and ASCs.
RCT Entities:
STUDY OBJECTIVE: To examine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure. DESIGN: Randomized, prospective, comparative setting clinical trial (Canadian Task Force classification II-2). SETTING: Nine outpatient obstetrics and gynecology practices and hospitals in the United States. PATIENTS: Women 18 to 55 years of age with polyps and/or type 0 or I myomas ≥1.5 and ≤3.0 cm. INTERVENTIONS: Treatment of polyps and fibroids with the MyoSure device. MEASUREMENTS AND MAIN RESULTS: A total of 118 lesions (76 polyps, 42 myomas) were removed. Among the 118 pathologies removed, 53 were removed in an office setting (28 myomas, 25 polyps), and 55 were removed in an ambulatory surgical center (ASC) setting (14 myomas, 41 polyps). The mean percentage of pathology removed was 95.9 ± 6.8% for fibroids and 99.9 ± 0.7% for polyps. Symptom severity as measured by the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scale improved significantly (p < .01) between baseline (mean score of 67.5 ± 15.4) and 12 months postprocedure (mean score of 22.3 ± 22.6). The Health-Related Quality of Life (HRQOL) scale also improved significantly (p < .01) between baseline (mean score 38.7 ± 23.3) and 12 months postprocedure (mean score of 83.9 ± 24.4). Both the office and ASC groups demonstrated a statistically significant (p < .01) improvement in UFS-QOL and HRQOL. CONCLUSION: For women with intrauterine polyps and/or myomas who experienced abnormal uterine bleeding, hysteroscopic morcellation with the MyoSure device provided significant, durable health-related, quality-of-life improvements up to 12 months postprocedure. These findings were the same for patients treated in both an office-based setting and ASCs.
Authors: Jan Bosteels; Steffi van Wessel; Steven Weyers; Frank J Broekmans; Thomas M D'Hooghe; M Y Bongers; Ben Willem J Mol Journal: Cochrane Database Syst Rev Date: 2018-12-05
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