Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
NCT Number: NCT06501144
Acronym: RELOED
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Erectile Dysfunction|Sexual Dysfunction
Sponsor: Kranus Health GmbH
Collaborators: Universität Münster
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 306
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-13
Completion Date: 2025-01-31
Locations: CeRa Münster, Münster, Germany

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.

Primary Outcome Measures: Assessment of the real-world longitudinal effect of the intervention, Rate of patients maintaining an improvement of at least 3 IIEF-5 points (vs baseline) of erectile dysfunction at a 3 months (± 1 week) follow-up past termination of the 3 months program using the IIEF-5 questionnaire (= 6 months after start of the therapy).

The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity. Based on IIEF, ED severity is classified into five categories: no ED (score 22-25), mild (17-21), mild to moderate (12-16), moderate (8-11), and severe (5-7). Higher scores mean a better outcome., 3 months (± 1 week) follow-up past termination of the 3 months program
Secondary Outcome Measures: Assessment of the real-world effect of the intervention on overall improvement of patients' health status, Assessment of overall improvement of patients' health status at a 3 months (± 1 week) follow-up past termination of the 3 months program using the PGI-I questionnaire (= 6 months after start of the therapy).

The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). The scale has a minimum value of 1 and a maximum value of 7 (very much better). Higher scores mean a better outcome., 3 months (± 1 week) follow-up past termination of the 3 months program|Assessment of the real-world effect of the intervention on disease-related quality of life, Assessment of disease-related quality of life at a 3 months (± 1 week) follow-up past termination of the 3 months program using the QOL-Med questionnaire (= 6 months after start of the therapy).

The questionnaire consists of of 18 questions and can be answered with 1-4 on a likert scale (4 -'Very much, 3 -'Moderately',2 --'A little', 1 not at all' ). It is then transformed in to a scale from 0-100 with 0 meaning the lowest quality of life and 100 the best quality of life., 3 months (± 1 week) follow-up past termination of the 3 months program