Effectiveness of a hysteroscopic tissue removal system device for hysteroscopic myomectomy on patients’ quality of life: a randomized clinical trial

PURPOSE: To evaluate the quality of life in patients treated for submucosal leiomyomas after hysteroscopic myomectomy compared to medical therapy. This is the first prospective randomized analysis comparing outcomes of medical therapy versus hysteroscopic myomectomy using the TruClear™ hysteroscopic tissue removal system to treat heavy menstrual bleeding from submucosal leiomyoma(s). METHODS: Setting: private practice and community-based hospital; subjects: female patients with symptomatic submucosal leiomyomas from 2014 to 2017. A total of 69 patients enrolled, with 47 completed. Statistical analysis used: randomization, linear mixed-effects modeling, hypothesis testing, and intent-to-treat analysis. 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. Main outcome measured: 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, 28.9, 28.6, and 32.2, respectively. CONCLUSION: Although there was no statistical difference in the change degree of improvement of overall quality of life among patients with symptomatic submucosal leiomyomas who received medical or surgical treatments in the study, there were greater differences in improvements in health-related quality of life scores over time after surgical treatment.