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| Name | Class |
|---|---|
| Centre of Reproductive Medicine and Andrology, department of Clinical and Surgical Andrology, Münster | UNKNOWN |
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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:
Participants will:
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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the real-world effect of the intervention on overall improvement of patients' health status | Assessment of overall improvement of patients' health status using the PGI-I questionnaire | 6 months after start of the app-based therapy |
| Assessment of the real-world effect of the intervention on disease-related quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Other outcome measures/variables |
Derived variables
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Inclusion Criteria:
Exclusion Criteria:
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.
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Kliesch, MD | CeRA Münster, Centre of Reproductive Medicine and Andrology , department of Clinical and Surgical Andrology, Münster, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CeRa Münster, Centre of Reproductive Medicine and Andrology | Münster | Germany | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35925101 | Background | 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. | |
| 38853028 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 10, 2026 | |
| Reset | Jul 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2026 | Jul 6, 2026 |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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Assessment of disease-related quality of life using the QOL-Med questionnaire |
| 6 months after start of the app-based therapy |
| 6 months after start of the app-based therapy |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |