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

NCT06501144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 317

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Centre of Reproductive Medicine and Andrology, department of Clinical and Surgical Andrology, Münster

    collaborator UNKNOWN

  • Kranus Health GmbH

    lead INDUSTRY

Principal Investigators

  • Sabine Kliesch, MD · CeRA Münster, Centre of Reproductive Medicine and Andrology , department of Clinical and Surgical Andrology, Münster, Germany

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-08
Primary Completion
2025-09-05
Completion
2025-09-08

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06501144 on ClinicalTrials.gov