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

NCT06501144 | Completed

• 1 other identifier: RELOED01
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 1

Brief 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

Sexual Dysfunction; Erectile Dysfunction

Keywords

Erectile Dysfunction; Digital Health; App-based Therapy; Digital Therapeutics; Real World Evidence; Mobile Health; Behavioral Interventions; Quality of Life; Lifestyle Changes; Urology

Outcome Measures

Primary Outcomes (1)

• Assessment of the real-world longitudinal effect of the intervention

  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 Outcomes (2)

• Assessment of the real-world effect of the intervention on overall improvement of patients' health status

  6 months after start of the app-based therapy

• Assessment of the real-world effect of the intervention on disease-related quality of life

  6 months after start of the app-based therapy

Other Outcomes (1)

• Other outcome measures/variables

  6 months after start of the app-based therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Because this study investigates the effects of a therapy program on erectile dysfunction, eligibility requires participants to have male primary genital anatomy, regardless of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kranus Health GmbH: lead
• Centre of Reproductive Medicine and Andrology, department of Clinical and Surgical Andrology, Münster: collaborator

Study Sites (1)

CeRa Münster, Centre of Reproductive Medicine and Andrology

Münster, Germany, 48149, Germany

Location

Related Publications (2)

• Wiemer L, Bartelheimer T, Raschke R, Miller K. [First data from a digital health app for erectile dysfunction]. Urologie. 2022 Sep;61(9):971-981. doi: 10.1007/s00120-022-01872-x. Epub 2022 Jun 20. German.

  PMID: 35925101 BACKGROUND

• Kliesch S, Cremers JF, Krallmann C, Epplen R, Scheffer B, Schubert T, Schubert M, Dreger NM, Raschke R, Khaljani E, Maxeiner A, Miller K, Wiemer L, Zitzmann M. App-based Therapy of Erectile Dysfunction Using a Digital Health Application (EDDIG Study): A Randomized, Single-blind, Controlled Trial. Eur Urol Focus. 2024 Dec;10(6):1003-1010. doi: 10.1016/j.euf.2024.05.020. Epub 2024 Jun 8.

  PMID: 38853028 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Sabine Kliesch, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: August 8, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 8, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-09

Locations

DE (1)