Abstract
Background: This is the first prospective randomized analysis comparing outcomes of medical therapy versus hysteroscopic myomectomy using the TruClearTM hysteroscopic tissue removal system to treat heavy menstrual bleeding from sub-mucosal leiomyoma(s). Objective: To evaluate the quality of life in patients treated for submucosal leiomyomas after hysteroscopy myomectomy compared to medical therapy. Study Design: Setting: private practice and community-based hospital; subjects: female patients with symptomatic submucosal leiomyomas from 2014-2017. A total of 69 patients enrolled, with 47 completed. Statistical analysis used: randomized clinical trial. Each patient was randomized to oral contraceptive pills/progesterone releasing intrauterine device or hysteroscopic myomectomy. Each patient was to complete the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) questionnaire at baseline, one month, three months, and greater than or equal to six months after treatment. Primary outcome was the health-related quality of life (HR-QOL), as reflected from UFS-QOL scores. Contrasts were constructed from a linear mixed-effects model to compare the two treatment groups for changes from baseline in UFS-QOL scores. Results: UFS-QOL scores were similar at baseline between the two treatment groups. There was an overall improvement in all UFS-QOL scores within each group. Higher improvement scores were noted in the surgical group compared to the medical group for almost all UFS-QOL scores. At ≥6 months, in comparison to the medically managed patients, the most considerable score improvements for the surgical group were reported in HR-QOL concern, activities, self-consciousness and symptom severity scores having mean change scores (95% CIs) of 35.3 (22.3 – 48.2), 28.9 (16.3 – 41.5), 28.6 (15.0 – 42.1), and 32.2 (21.5 – 43.0), respectively. Conclusion: Patients with submucosal leiomyomas who received medical or surgical treatment reported similar improvement in overall HR-QOL scores.
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