Status:
UNKNOWN
Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Erectile Dysfunction
Eligibility:
MALE
20-85 years
Phase:
PHASE3
Brief Summary
Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients...
Detailed Description
In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is appl...
Eligibility Criteria
Inclusion
- ED of more than 6 months
- Rigidity score \< 3 during PDE5i therapy
- SHIM \<21 during PDE5i therapy
- Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months
Exclusion
- Prior prostatectomy surgery
- Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
- Clinically significant chronic hematological disease
- Anti-androgens, oral or injectable androgens
- Radiotherapy in pelvic region
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01262157
Start Date
April 1 2010
End Date
January 1 2012
Last Update
May 19 2011
Active Locations (1)
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1
Rambam Medical Center
Haifa, Israel, Israel, 31096