Treatment of women with heavy menstrual bleeding
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The objective of this study was to compare the reintervention rate of women who opted for treatment with the levonorgestrel-releasing intrauterine system LNG-IUS to women who opted for endometrial ablation. Furthermore, the difference in reintervention rate between women in this observational cohort and women who were randomised was compared, with the hypothesis that women who actively decide on treatment have lower reintervention rates compared to women in a RCT.

An observational cohort study alongside a multicentre randomised controlled trial (RCT) was conducted, with a follow-up time of 24 months, in 26 hospitals and nearby general practices in the Netherlands. Women suffering from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future fertility desire, were eligible for this trial. Women who declined randomisation were asked to participate in the observational cohort. The outcome measure was reintervention rate at 24 months of follow-up.

276 women were followed in the observational cohort of which 87 women preferred an initial treatment with levonorgestrel-releasing intrauterine system and 189 women preferred an initial treatment with endometrial ablation. At 24 months of follow-up women in the levonorgestrel-releasing intrauterine system-group were more likely to receive a reintervention compared to the women in the ablation group, 28/81 (35%) versus 25/178 (14%). No differences in reintervention rates were found between women in the observational cohort and women in the RCT.

Women who receive a levonorgestrel-releasing intrauterine system are more likely to undergo an additional intervention compared to women who receive endometrial ablation. Reintervention rates of women in the cohort and RCT population were comparable. The results of this study endorse the findings of the RCT and will contribute to shared decision making in women with heavy menstrual bleeding.