Randomised comparative trial of thermal balloon ablation and levonorgestrel intrauterine system in patients with idiopathic menorrhagia

Abstract

To compare the effectiveness of thermal balloon ablation (TBA) and levonorgestrel intrauterine system (LNG-IUS) in the management of idiopathic menorrhagia and changes in pictorial blood loss assessment chart (PBAC) scores in patients who had failed on oral medical treatment. Phase III, single-centre, open randomised controlled trial. Following full screening and evaluation of 104 women, 33 were randomised to TBA and 33 to LNG-IUS. Primary outcomes were changes in PBAC scores from baseline to 12 months. Secondary outcomes were changes in haemoglobin and serum ferritin, at six months, continuation with treatment and hysterectomy rates at two years and changes in PBAC scores at three, six and nine months. All patients randomised had a PBAC score of > or = 120. At all assessment times, median PBAC scores were less than baseline, the greatest reductions being seen at 12 months for both treatments. When the median PBAC for the LNG-IUS (26 (0-68)) was significantly different to the median PBAC for the TBA cohort (62 (0-142)) P < 0.001. Irregular bleeding problems were the most common reason for discontinuation of the LNG-IUS and resulted in more women (39.8%) seeking other treatment by two years than the TBA (23.1%) (P < 0.05) and more undergoing a hysterectomy (20.7% vs 13.3%, respectively) (p > 0.05). Patient acceptability of the LNG-IUS and TBA was similar at 12 and 24 months in terms of their perceived satisfaction of effect on menorrhagia. Both TBA and LNG-IUS achieved significant decreases in PBAC scores, with those for the LNG-IUS being significantly greater at 12 months. However, prolonged days of bleeding resulted in fewer women continuing with the LNG-IUS at two years.