NCT01317693
Unknown
Phase 3
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
ConditionsErectile Dysfunction
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success
- Last Updated
- 13 years ago
Overview
Brief Summary
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 applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.
Investigators
i_gruenwald
MD
Rambam Health Care Campus
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success
Time Frame: 13 weeks
Secondary Outcomes
- Rigidity Score Questionaire- an increase by at least 1 point is considered success(13 weeks)
Study Sites (1)
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