Status:
COMPLETED
Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
Lead Sponsor:
Kranus Health GmbH
Collaborating Sponsors:
Centre of Reproductive Medicine and Andrology, department of Clinical and Surgical Andrology, Münster
Conditions:
Erectile Dysfunction
Sexual Dysfunction
Eligibility:
MALE
18+ years
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 ...
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 compone...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 8 2025
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT06501144
Start Date
August 8 2024
End Date
September 8 2025
Last Update
September 15 2025
Active Locations (1)
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1
CeRa Münster, Centre of Reproductive Medicine and Andrology
Münster, Germany, 48149