OBJECTIVE: To determine the feasibility (safety, potential efficacy and cost effectiveness) of a miniature endoscopic bipolar electrosurgical intrauterine system in the treatment of symptomatic submucous fibroids. STUDY DESIGN: A total of 37 women with symptomatic submucous fibroids were identified on outpatient hysteroscopy. All underwent hysteroscopic excision or ablation using a bipolar intrauterine system (Versapoint). The main outcomes measures were change in uterine bleeding symptoms measured on a continuous and ordinal scale, patient satisfaction, time of work and use of health service resources at 6 months following treatment. RESULTS: 36/37 (97%) women returned completed outcome questionnaires. The mean amount of abnormal uterine bleeding was reduced at 6 months compared to immediately prior to treatment (P=0.0001). Improvement in bleeding symptoms was reported by 28/36 (78%) women and satisfaction with treatment by 33/36 (92%) women. All procedures were successfully completed, there were no serious operative complications and at 6 months no repeat hysteroscopic procedures were necessary. The mean cost of diagnosis and treatment of submucous fibroids using an endoscopic bipolar intrauterine system was 40% cheaper at 6 months follow-up than a hysterectomy or open myomectomy ( pound 1266 versus pound 2123). CONCLUSION:Hysteroscopic treatment of symptomatic submucous fibroids appears to be safe, efficacious and cost effective. It seems feasible to launch a randomised controlled trial to confirm these provisional results in both the short and longer term.
RCT Entities:
OBJECTIVE: To determine the feasibility (safety, potential efficacy and cost effectiveness) of a miniature endoscopic bipolar electrosurgical intrauterine system in the treatment of symptomatic submucous fibroids. STUDY DESIGN: A total of 37 women with symptomatic submucous fibroids were identified on outpatient hysteroscopy. All underwent hysteroscopic excision or ablation using a bipolar intrauterine system (Versapoint). The main outcomes measures were change in uterine bleeding symptoms measured on a continuous and ordinal scale, patient satisfaction, time of work and use of health service resources at 6 months following treatment. RESULTS: 36/37 (97%) women returned completed outcome questionnaires. The mean amount of abnormal uterine bleeding was reduced at 6 months compared to immediately prior to treatment (P=0.0001). Improvement in bleeding symptoms was reported by 28/36 (78%) women and satisfaction with treatment by 33/36 (92%) women. All procedures were successfully completed, there were no serious operative complications and at 6 months no repeat hysteroscopic procedures were necessary. The mean cost of diagnosis and treatment of submucous fibroids using an endoscopic bipolar intrauterine system was 40% cheaper at 6 months follow-up than a hysterectomy or open myomectomy ( pound 1266 versus pound 2123). CONCLUSION: Hysteroscopic treatment of symptomatic submucous fibroids appears to be safe, efficacious and cost effective. It seems feasible to launch a randomised controlled trial to confirm these provisional results in both the short and longer term.