N48.4
Conditions
Interventions
Group 1: intervention: multimodal self-management via Kranus Edera App over a 12 week period
Group 2: controll group: Patients on the waiting list for the app, no new treatments for 12 weeks
Sponsors
Kranus Health GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: IIEF = 21 in IIEF-5-questionnaire men over 18 years
Exclusion criteria
Exclusion criteria: Patients with serious cardiac risk factors (moderate to severe risk according to the Princeton classification) unstable or refractory angina pectoris, uncontrolled hypertension, congestive heart failure (NYHA class III-IV), high-risk arrhythmia (exercise-induced ventricular tachycardia, implanted internal cardioverter defibrillator with frequent shocks, and poorly controlled atrial fibrillation), obstructive hypertrophic cardiomyopathy with severe symptoms, and moderate to severe valve disease, particularly aortic stenosis) Patients with myocardial infarction within the last six months s/p. prostatectomy, radiation or seeds of the prostate s/p bigger surgery in the small pelvis with likelihood of nerval damage (eg rectal resection, cystectomy) nerval diseases (eg multiple sclerosis (MS), parkinson´s disease, apoplex, dementia, psychiatric diseases) s/p trauma to the pelvis/penile region/spine Active autoinjection therapy (SKAT, MUSE) Patients with orthopaedic conditions that do not allow to perform the extended pelvic floor exercises
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary endpoints: improvement of the IIEF score (erection score), improvement of qualiity of life (QoLMed questionnaire), improvement of patient activation (PAM13) | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement of bloodpressure, BMI, hip-to-waist ratio | — |
Countries
Germany
Contacts
Public ContactLaura Wiemer
Kranus Health GmbH
Outcome results
None listed