Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding

BackgroundHeavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system endometrial ablation are 2 frequently applied treatments in women with heavy bleeding.ObjectiveThis study aimed to compare effectiveness bleeding.Study DesignThis multicenter, randomized controlled, noninferiority trial was performed 26 hospitals a network general practices Netherlands. Women bleeding, aged 34 years older, without pregnancy wish or intracavitary pathology were randomly allocated treatment either (Mirena) ablation, bipolar radiofrequency device (NovaSure). primary outcome blood loss at 24 months, measured Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality life, sexual function.ResultsWe registered 645 as eligible, whom 270 provided informed consent. Of these, 132 (baseline score, 616) 138 630). At mean scores 64.8 group 14.2 (difference, 50.5 points; 95% confidence interval, 4.3–96.7; noninferiority, P=.87 [25 point margin]). Compared 14 (10%) group, (27%) underwent surgical (relative risk, 2.64; 1.49–4.68). There no significant difference satisfaction life between groups.ConclusionBoth strategies lead large decrease comparable after treatment. Nevertheless, there favor we could not demonstrate starting system. who start system, reversible less invasive treatment, an increased risk needing additional compared ablation. results this will enable physicians provide evidence make well-informed decision treatments. Heavy bleeding. This function. We groups. Both