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

February 12, 2026 updated by: Kranus Health GmbH

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

317

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Germany
      • Münster, Germany, Germany, 48149
        • CeRa Münster, Centre of Reproductive Medicine and Andrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study will include adults with erectile dysfunction who have started the 3-month therapy with the app-based therapeutic within the last 6 months

Description

Inclusion Criteria:

  • Men with erectile dysfunction of organic origin (ICD 10 code N48.4) and IIEF-5 score < 21 as determined at therapy start with Kranus EDERA
  • Completion of the 12-week app-based therapy with Kranus EDERA
  • Improvement in the IIEF-5 score of ≥ 3 points after completion of the Kranus EDERA therapy compared to the score at the start of the therapy
  • Age over 18

Exclusion Criteria:

  • Failure to provide informed consent
  • Started a new therapy with Kranus EDERA between the end of the last therapy cycle and patient survey
  • Started PDE-5 inhibitor treatment during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
  • Underwent prostatectomy (removal of the prostate gland), radiation or seeds of the prostate gland during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
  • Performed auto-injection therapy (SKAT, MUSE) during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
  • Obtained a penile implant during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
  • Underwent major surgery in the small pelvis with probable impairment of the neurovascular supply (e.g., rectum resection, urinary bladder removal) during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
  • Nervous diseases (e.g., multiple sclerosis (MS), Parkinson's disease, stroke, dementia, psychiatric diseases) acquired during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
  • Developed pronounced circulatory disorders (peripheral arterial occlusive disease) during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
  • Trauma involving the pelvis/penis/spine during the Kranus EDERA therapy or between the end of the last therapy cycle and patient survey
  • Any other newly developed diseases potentially affecting erectile function (e.g., leading to a longer period of hospitalization) during the Kranus EDERA therapy or between the end of the therapy cycle and patient survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the real-world longitudinal effect of the intervention
Time Frame: 6 months after start of the app-based therapy
The primary endpoint is the rate of patients maintaining an IIEF-5 score improvement of ≥ 3 points compared to baseline (start of app-based therapy) after the app-based therapy
6 months after start of the app-based therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the real-world effect of the intervention on overall improvement of patients' health status
Time Frame: 6 months after start of the app-based therapy
Assessment of overall improvement of patients' health status using the PGI-I questionnaire
6 months after start of the app-based therapy
Assessment of the real-world effect of the intervention on disease-related quality of life
Time Frame: 6 months after start of the app-based therapy
Assessment of disease-related quality of life using the QOL-Med questionnaire
6 months after start of the app-based therapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other outcome measures/variables
Time Frame: 6 months after start of the app-based therapy
  • Demographics and patient characteristics (specified in the study protocol)

  • IIEF-5

    •. PGI-I

  • QOL-MED
  • BMI changes
  • Responders (A priori responder definition of patients with the minimal important difference (MID) of an ≥ 3 points IIEF-5 score improvement to assess the maintenance of a therapeutic effect according to the hypothesis this study aims to investigate)

Derived variables

  • Changes of IIEF-5 from baseline
  • Changes of IIEF-5 from baseline
  • Changes of IIEF-5 from end of therapy
6 months after start of the app-based therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kranus Health GmbH

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2024

Primary Completion (Actual)

September 5, 2025

Study Completion (Actual)

September 8, 2025

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RELOED01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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