Digital Medical Device Companion (MyIUS) for New Users of Intrauterine Systems: App Development Study

Area of Science:

• Digital Health
• Women's Health
• Contraception

Background:

• Levonorgestrel-releasing intrauterine systems can alter menstrual bleeding patterns.
• Women need individualized information and support for postplacement bleeding changes.
• Current support methods for managing bleeding changes are limited.

Purpose of the Study:

• To develop the MyIUS mobile app, a digital companion for women using intrauterine systems.
• To provide individualized information on expected bleeding patterns and ongoing support.
• To address the unmet need for managing postplacement bleeding changes.

Main Methods:

• The MyIUS app, a medical device, uses an AI-based algorithm to predict bleeding intensity and regularity.
• Developed through a phased approach by a multidisciplinary team.
• Incorporated user feedback from women and healthcare professionals during design.

Main Results:

• The MyIUS app was found useful by healthcare professionals and easy to use by women.
• Pilot country launch planned to gather performance metrics for future updates.
• A real-world performance study will validate the algorithm and app compliance.

Conclusions:

• The MyIUS app provides a valuable tool for individualized counseling and discussions on contraceptive choices.
• It may benefit both women and healthcare professionals managing bleeding patterns.
• Further validation of the app and its prediction algorithm in real-world settings is necessary.