Real-world validation of a bleeding prediction algorithm in levonorgestrel intrauterine device users using the MyIUS mobile app.

Objective: This study aimed to validate the real-world performance of the MyIUS mobile-application algorithm in predicting bleeding intensity and regularity in levonorgestrel intrauterine device (LNG-IUD) 52 mg, 19.5 mg, and 13.5 mg users following device insertion.

Study Design: This was an observational real-world performance study conducted in Germany, Denmark, Sweden, Spain, Mexico, and Brazil, including women aged ≥18 who provided electronic written informed consent and had used the MyIUS app for 90 days following LNG-IUD 52 mg, 19.5 mg, or 13.5 mg insertion. At day 90, participants received personalized bleeding predictions for one of three bleeding intensity clusters (predominantly amenorrhea, predominantly spotting, or predominantly bleeding), with those predicted predominantly spotting or predominantly bleeding receiving regular or irregular cycle predictions. After the 270-day data collection period, bleeding data self-reported from the last 180 days were evaluated and compared with the bleeding profile prediction.

Results: Based on 1,734 participants with close-to-complete datasets, the overall multiclass area under the curve (AUC) for the three LNG-IUDs was 0.81 (95% confidence interval [CI], 0.79-0.83) for bleeding intensity prediction, corresponding to sufficient discrimination in algorithm performance based on predefined thresholds. The overall AUC for menstrual cycle regularity prediction was 0.66 (95% CI, 0.63-0.68).

Conclusion: Results validated the bleeding intensity prediction algorithm in a real-world environment, providing evidence to support the global use of MyIUS for individualized insights into bleeding changes following LNG-IUD insertion. Further refinement of the algorithm, especially regarding its performance in predicting cycle regularity, and testing of its clinical utility are warranted.

Implications: This study validated the mobile application-housed bleeding prediction algorithm MyIUS in predicting bleeding intensity in levonorgestrel intrauterine device (LNG-IUD) users following insertion in a real-world setting, supporting the global use of MyIUS for individualized insights into bleeding changes following LNG-IUD insertion.