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

Recruiting

• Conditions: Sexual Dysfunction; Erectile Dysfunction

• Registration Number: NCT06501144
• Lead Sponsor: Kranus Health GmbH

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.

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 Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Study Start: 2024-08-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 285

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the real-world longitudinal effect of the intervention	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CeRa Münster, Centre of Reproductive Medicine and Andrology; 🇩🇪 Münster, Germany