Long-term follow-up of a digital health app for erectile dysfunction
Real-world Longitudinal Follow-up Study of a Digital Health Application in Erectile Dysfunction
This study is testing if a digital health app can help men with erectile dysfunction improve their condition and maintain those improvements over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 285 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Kranus Health GmbH Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Münster) |
| Trial ID | NCT06501144 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term effectiveness of a digital health application designed to treat erectile dysfunction in men aged 18 and older. Participants will engage in a 12-week self-management program that includes pelvic floor exercises, cardiovascular training, psychological support, and educational content. They will complete validated questionnaires to track improvements in erectile function, overall health status, and quality of life at multiple follow-up points. The study seeks to determine if participants can maintain an improvement of at least 3 points in their erectile function score three months post-therapy.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with erectile dysfunction of organic origin and an initial IIEF-5 score below 21.
Not a fit: Patients who have undergone prostatectomy, radiation, or have started PDE-5 inhibitor treatment during the therapy period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive, effective treatment option for men suffering from erectile dysfunction.
How similar studies have performed: Other studies have shown promise in using digital health applications for managing erectile dysfunction, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Münster
- CeRa Münster, Centre of Reproductive Medicine and Andrology — Münster, Germany (Recruiting)
Study contacts
- Principal investigator: Sabine Kliesch, MD — CeRA Münster, Centre of Reproductive Medicine and Andrology , department of Clinical and Surgical Andrology, Münster, Germany
- Study coordinator: Laura Wiemer, MD
- Email: reloedstudie@kranus.de
- Phone: 0049 89 12080620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.