Status:
UNKNOWN
Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Erectile Dysfunction
Eligibility:
MALE
20-80 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
At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form, and will be aske...
Eligibility Criteria
Inclusion
- ED for more than six months in duration.
- At least 50% unsuccessful sexual intercourses for 4 attempts at 4 different days.
- Previous positive experience with PDE5iswithin the past six months.
- A minimum of two sexual attempts per month.
- An IIEF-ED domain score of ≥19, post screening PDE5i intake.
- An IIEF-ED domain score of ≥17 and a Rigidity score ≥ 3 , post screening with PDE5i intake
- A Rigidity score ≥ 3 post screening PDE5i intake.
- A stable heterosexual relationship with the same partner for more than three months.
- Delta IIEF-ED domain score ≤5 points on visit 1 (after 1 month wash out) compared to the IIEF-ED domain score on screening.
Exclusion
- Prior prostate surgery.
- Any cause of ED other than of vascular etiology.
- Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities including Peyrone's disease.
- Clinically significant chronic hematological disease.
- Cardiovascular conditions that prevent sexual activity.
- History of heart attack, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study.
- Cancer within the past five years.
- Use of anti-androgens, or oral or injectable androgens
- Use of any other treatments for ED that includes oral medications, vacuum devices, constrictive devices, injections, or urethral suppositories within seven days of screening.
- Hormonal, neurologic, or psychological pathology.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01442077
Start Date
November 1 2011
End Date
November 1 2013
Last Update
January 18 2012
Active Locations (1)
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1
Rambam Medical Center
Haifa, Israel