NCT06501144

Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 317 (actual)
• Sponsor: Kranus Health GmbH · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to assess the long-term effectiveness of a digital health application for treating erectile dysfunction in men aged 18 and older. The main questions it aims to answer are: * Will participants maintain an improvement of their erectile function, that means maintain an improvement of at least 3 points in the IIEF-5 score at 3 months post-therapy? * How does the application affect overall health status and disease-related quality of life? Participants will: * Complete validated questionnaires (IIEF-5, PGI-I, QOL-Med) to track erectile function, overall health status, and quality of life at up to two follow-up points after using the app with a 3-month self-management program combining cardiovascular training, pelvic floor exercises, psychological support, and educational content. * Provide information on demographics, risk factors, and other relevant health characteristics for subgroup analysis.

Detailed description

The intervention that needs to be completed prior participation in this study involves a digital therapy program delivered via a smartphone or tablet application. This program includes several components aimed at addressing different aspects for the treatment of erectile dysfunction: * Pelvic Floor Exercises * Cardiovascular Exercises * Physiotherapeutic Exercises * Mental or sexual therapeutic Exercises * Educational Content Overall, the digital therapy program is designed to provide comprehensive support for men with erectile dysfuntion, addressing both physical and psychological aspects of the condition to improve symptom severity, quality of life, and patient activation.

Conditions

• Erectile Dysfunction
• Sexual Dysfunction

Timeline

• Start date: 2024-08-08
• Primary completion: 2025-09-05
• Completion: 2025-09-08
• First posted: 2024-07-15
• Last updated: 2026-02-13

Locations

1 site across 1 country: Germany