A randomised trial comparing the levonorgestrel intrauterine system and thermal balloon ablation for heavy menstrual bleeding

Abstract

Objective To compare the levonorgestrel intrauterine system (LNG‐IUS) (Mirena^®; Schering Co., Turku, Finland) and thermal balloon ablation (Thermachoice™; Gynecare Inc., Menlo Park, CA, USA) for the treatment of heavy menstrual bleeding. Design An open, pragmatic, prospective randomised trial. Setting A menstrual disorders clinic at National Women's Hospital, Auckland, New Zealand. Population Seventy‐nine women with heavy menstrual bleeding randomised to the LNG‐IUS (40 women) or the thermal balloon ablation (39 women). Methods Women were randomised to treatment with the LNG‐IUS or thermal balloon ablation and followed up by a postal and telephone questionnaire. Main outcome measures Menstrual loss measured by a pictorial bleeding assessment chart (PBAC) at 3, 6, 12 and 24 months. Patient satisfaction, quality of life and menstrual symptoms were assessed by questionnaire administered at 3, 6, 12 and 24 months. Treatment side effects and treatment failures were also recorded. Results Both the treatments resulted in a significant reduction in PBAC scores. At 12 and 24 months, median PBAC scores were significantly lower in women treated with the LNG‐IUS compared with women treated by thermal balloon ablation (11.5 versus 60.0 at 12 months [P= 0.002]; 12.0 versus 56.5 [P= 0.002] at 24 months). At 24 months, nine (35%) women still using the LNG‐IUS had amenorrhoea compared with one (5%) woman successfully treated by thermal balloon ablation (P= 0.025). There were no significant differences in patient satisfaction between two treatments during follow up. Treatment failed in 11 (28%) women using the LNG‐IUS and in 10 (26%) women treated with thermal balloon ablation. Overall, women in both groups showed an increased quality of life as a result of the treatment, with Short Form‐36 scores increasing from 63.7 at randomisation to 76.1 at 24 months. Conclusions At 12 and 24 months of follow up, women with heavy menstrual bleeding treated with the LNG‐IUS have significantly lower PBAC scores than women treated with thermal balloon ablation. Both the treatments resulted in a significant increase in overall quality of life, but there were no significant differences between either treatment in quality of life, patient satisfaction or the number of women requesting an alternative treatment during 24 months of follow up.