European journal of obstetrics, gynecology, and reproductive biology · 2025
Model for the prediction of therapeutic failures of the 52 mg levonorgestrel intrauterine device.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Pujol Alex, Castañeda-Vozmediano Raúl, Bordés María, Plaza Javier
Аннотация
INTRODUCTION: The 52 mg levonorgestrel intrauterine device (LNG-IUD) is used for contraception and the treatment of heavy menstrual bleeding. However, it may be associated with complications such as expulsion, early removal, and, in some cases, hysterectomy. Few studies have evaluated the clinical factors predicting these failures.
OBJECTIVE: To develop a predictive model using indications for LNG-IUD use (contraception or treatment of PALM-COEIN conditions) to predict risk of failure (expulsion, early removal, and hysterectomy).
METHODS: A retrospective observational study of 651 women undergoing Mirena® LNG-IUD implantation between 2008 and 2020. Indications for insertion were analyzed. Survival models (Cox, Fine-Gray) assessed risk of expulsion and early removal, while logistic regression modeled risk of hysterectomy.
RESULTS: The LNG-IUD remained effective for an average of 3.3 ± 2.0 years, with failure rates of 11.7 % (expulsion), 14.1 % (early removal), and 4.8 % (hysterectomy). In multivariate analysis, submucosal leiomyomas and malignancy-hyperplasia significantly increased the risk of expulsion (HR 2.85 and 2.51; sHR 2.71 and 2.64, respectively), while other leiomyoma types (HR 2.2) and ovulatory-endometrial dysfunction (HR 1.9; sHR 1.61) were associated with early removal. Hysterectomy risk was notably higher in patients with submucosal (OR 7.04) and other leiomyomas (OR 5.79).
CONCLUSIONS: This study, the first to assess LNG-IUD effectiveness using survival analysis, identifies leiomyomas, malignancy-hyperplasia, and ovulatory-endometrial dysfunction as key predictors of failure. These findings could improve patient selection and management, potentially reducing major surgeries.
OBJECTIVE: To develop a predictive model using indications for LNG-IUD use (contraception or treatment of PALM-COEIN conditions) to predict risk of failure (expulsion, early removal, and hysterectomy).
METHODS: A retrospective observational study of 651 women undergoing Mirena® LNG-IUD implantation between 2008 and 2020. Indications for insertion were analyzed. Survival models (Cox, Fine-Gray) assessed risk of expulsion and early removal, while logistic regression modeled risk of hysterectomy.
RESULTS: The LNG-IUD remained effective for an average of 3.3 ± 2.0 years, with failure rates of 11.7 % (expulsion), 14.1 % (early removal), and 4.8 % (hysterectomy). In multivariate analysis, submucosal leiomyomas and malignancy-hyperplasia significantly increased the risk of expulsion (HR 2.85 and 2.51; sHR 2.71 and 2.64, respectively), while other leiomyoma types (HR 2.2) and ovulatory-endometrial dysfunction (HR 1.9; sHR 1.61) were associated with early removal. Hysterectomy risk was notably higher in patients with submucosal (OR 7.04) and other leiomyomas (OR 5.79).
CONCLUSIONS: This study, the first to assess LNG-IUD effectiveness using survival analysis, identifies leiomyomas, malignancy-hyperplasia, and ovulatory-endometrial dysfunction as key predictors of failure. These findings could improve patient selection and management, potentially reducing major surgeries.