Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction (NCT06501144) | Clinical Trial Compass
CompletedNot Applicable
Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
Germany317 participantsStarted 2024-08-08
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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) …
What they're measuring
1
Assessment of the real-world longitudinal effect of the intervention
Timeframe: 6 months after start of the app-based therapy