Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)
NCT ID: NCT02068417
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
40 participants
INTERVENTIONAL
2011-10-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Shock wave treatment
Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)
shock waves
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Placebo Shock wave treatment
Shock waves are prohibited to enter the body by placebo stand-off.
shock waves
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Interventions
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shock waves
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
MALE
No
Sponsors
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Storz Medical AG
INDUSTRY
Responsible Party
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Locations
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Bethanien Krankenhaus Chemnitz gemeinnützige GmbH
Chemnitz, , Germany
Countries
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Other Identifiers
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STU10/002
Identifier Type: -
Identifier Source: org_study_id
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