Outcomes of Levonorgestrel Intrauterine System and Rollerball Ablation in Treatment of Menorrhagia

Abstract

Aim: To compare the efficacy, safety and satisfaction of rollerball ablation (RBA) with that of levonorgestrel intrauterine system (LNGIUS) in control of heavy menstrual bleeding (HMB). Patients and 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. Themain 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 satisfaction, 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 that the results in term of PBAC scores and in hemoglobin were initially with RBA, eventually both two treatmentmodalities shown 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 shows that both LNG - IUS and RBA were effective in control HMB as well as safe and associated with high level of satisfaction and better quality of life than to pretreatment period. Choice between this two treatment modalities should be based on surgeon skill and women preferences.