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Clinical Trials/DRKS00029182
DRKS00029182CompletedPhase 3

Prospective randomized trial to evaluate a multimodal digital app in the treatment of erectile dysfunction - EDDIG

Kranus Health GmbH0 sites241 target enrollmentStarted: June 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
241

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized controlled study
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to one (—)
Sex
Male

Inclusion Criteria

  • IIEF = 21 in IIEF-5-questionnaire
  • men over 18 years

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

Investigators

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