Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
NCT ID: NCT00901056
Last Updated: 2011-01-25
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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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2008-11-30
2010-03-31
Brief Summary
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The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treated Group
This group will receive actual shockwave treatment
Extracorporeal Shockwave Therapy
Energy Density - 0.02 - 0.15 mJ/mm2
Interventions
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Extracorporeal Shockwave Therapy
Energy Density - 0.02 - 0.15 mJ/mm2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
* Positive response to PDE-5 inhibitors
* IIEF-5 domain score of 12-20 denoting mild to severe ED
* Non-Neurological pathology
* Stable heterosexual relationship for more than 3 months
Exclusion Criteria
* Prior prostatectomy surgery
* Any cause of ED other than vascular related
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Cardiovascular conditions that prevent sexual activity
* History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
* Cancer within the past 5 years.
* Anti-androgens, oral or injectable androgens
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
18 Years
MALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Medispec
INDUSTRY
Responsible Party
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Rambam Medical Center
Principal Investigators
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Yoram Vardi, Professor
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam Medical Center
Haifa, , Israel
Countries
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Other Identifiers
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ED-ESWT
Identifier Type: -
Identifier Source: org_study_id
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