Erectile Dysfunction
Conditions
Keywords
IIEF score, ED
Brief summary
The objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.
Interventions
DEVICEshock waves
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Sponsors
Storz Medical AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Erectile dysfunction for more than 6 months * Informed consent * Positive effect of phosphodiesterase type 5 inhibitor (PDE5i) * IIEF-15 score less than 20 * No neurological disease * Stable partnership for more than 3 months * Age 18-75
Exclusion criteria
* Total prostatectomy * Another reason for ED except for vascular disorder * Clinically significant hematological disease * Heart stroke, Arrythmia during the last 6 months * Cancer during the last 5 years * Intake of antiandrogen * ED treatment with the last 7 days * IIEF score higher than, equal to 20 * Previous shockwave treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire) | up to 6 months post treatment |
Secondary
| Measure | Time frame |
|---|---|
| Quality of erection (Quality of Erection Questionnaire) | At screening, 1, 3 and 6 months post treatment |
Countries
Germany
Outcome results
None listed