Aim: To compare the efficacy, safety and satisfaction of Rollerball ablation (RBA) with that of levonorgestrel intrauterine system (LNG-IUS) in control of heavy menstrual bleeding (HMB).
Patients & Methods: An open label prospective randomized controlled trial was conducted between October 2014 and March 2017 in Benha University Hospital, Benha, Egypt. Eighty four eligible women with functional HMB (aged 35 years and 45 years, uterine size 10 weeks gestational size, uterocervical length 10 cm) were randomly assigned (1 : 1), 42 women in each group, to undergo RBA procedures or LNG- IUS insertions by closed envelops method and followed up to 24 months after the procedures. The main outcomes were menstrual blood loss as assessed by pictorial bleeding assessment chart (PBAC) and hemoglobin values (g/dl) at 3, 6, 12, 24 months. Also, women's satisfaction, and patients' quality of life were evaluated by questionnaire administered at 3, 6, 12, 24 months. Treatment modality side effects, safety and treatment failures were also assessed.
Results: Both treatment modalities resulted in a significant reduction of PBAC scores and elevation of hemoglobin values. Also, both treatments were associated with higher significant satisfaction, and quality of life. Despite the fact that the results in terms of PBAC scores and in hemoglobin were initially with RBA, eventually both two treatment modalities showed no significant difference at 12, 24 months. Follow up both the treatment modalities were associated with comparable treatment failure rates (13%).
Conclusions: Women treated with both LNG-IUS and RBA for HMB follow up to 24 months showed that both LNG - IUS and RBA were effective in control of HMB as well as safe and associated with high level of satisfaction and better quality of life than to pretreatment period. Choice between these two treatment modalities should be based on surgeon skill and women preferences.
Keywords: levonorgestral intrauterine system - heavy menstrual bleeding - rollorball ablation - endometrial ablation - menorrhagia. |
