N48.4
Conditions
Interventions
Group 1: Intervention group: Patients receive access to the digital health application Promano for an initial study period of 12 weeks (primary endpoint), in addition to their usual standard care.
Gro
Sponsors
Promano-Health GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General inclusion criteria: - Biologically male adults (aged =18 years) - Confirmed diagnosis of ED of organic origin (ICD-10 code: N48.4) - IIEF-EF domain score <26 - Good knowledge of German (at least level B2 or comparable) - Ability to use an application installed on a smartphone or other Internet-enabled mobile device - Own mobile device that meets the technical requirements for using the Promano app Study-specific inclusion criteria: - No mobility restrictions that would prevent the performance of app-specific physical exercises - Written consent of the study participant after receiving information - Living in Germany
Exclusion criteria
Exclusion criteria: General exclusion criteria: - Cognitive impairment or mental illness that could interfere with compliance with study requirements or consent to participate in the study - Inability or unwillingness to use the app (e.g., blindness, limited informal self-determination) - Persons in a dependent relationship/employment relationship with the sponsor or investigator Specific exclusion criteria: - Autoinjection therapy (SKAT) or another form of PGE1 application to the penis (MUSE, VITAROS) currently or within 8 weeks prior to study start - Medication for erectile dysfunction, such as phosphodiesterase type 5 inhibitors, currently or within 8 weeks prior to study entry - Active or planned participation in other intervention studies for the treatment of ED in the last 6 months or during the study period - Use of another smartphone application for the treatment of ED in the last 6 months or planned use of another app-based program for the treatment of ED Additional medical exclusion criteria: • Symptomatic angina pectoris • Symptomatic heart failure NYHA III-IV or cardiomyopathies (e.g., HOCM) • High-risk cardiac arrhythmias: ventricular tachycardia, bradyarrhythmia absoluta (heart rate 150 bpm), untreated QT prolongation with survived sudden cardiac death (self-reported) • Moderate to severe heart valve disease (valvulopathies, self-reported, e.g., symptomatic mitral regurgitation 3, aortic stenosis 3) • Untreated blood pressure above 170/100 mmHg • Pre-existing symptomatic higher-grade chronic lung disease (fibrosis, pneumoconiosis, adult allergic diseases such as farmer's lung, severe pulmonary emphysema, COPD = grade III) • Heart attack or stroke in the last 6 weeks • Condition following surgery that has resulted in injury to both nerve bundles (neurovascular bundles) and other penile neural structures, significantly limiting activity (e.g., prostatectomy, rectal resection) • Neurological or psychiatric disorders with potential impairment of neuro(vascular) function (e.g., multiple sclerosis, Parkinson's disease, dementia) • End-stage renal failure with hemodialysis treatment (ICD code N18.5)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean individual change in erectile function (EF domain score) after 12 weeks of treatment in the intervention group compared with the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean individual change after 12 weeks of treatment in the intervention group compared with the control group with regard to: – disease-related quality of life (QoL-Med score) – patient activation and health literacy (PAM-13 score) | — |
Countries
Germany
Contacts
Public ContactMichael Mathers
Urologie Castrop
Outcome results
None listed