Status:
COMPLETED
Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction
Lead Sponsor:
Medispec
Collaborating Sponsors:
Rambam Health Care Campus
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the sy...
Detailed Description
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave appl...
Eligibility Criteria
Inclusion
- ED of more than 6 months
- 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
- NPT - normal/flat
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00901056
Start Date
November 1 2008
End Date
March 1 2010
Last Update
January 25 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rambam Medical Center
Haifa, Israel