Erectile Dysfunction Clinical Trial
— LI-ESWTOfficial title:
The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication
Verified date | September 2011 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Post Radical prostatectomy - ED of more than 6 months - Rigidity score = 2 during PDE5i therapy - Stable heterosexual relationship for more than 3 months - Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 . Exclusion Criteria: - Prior surgery or radiotherapy in pelvic region - Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities - Clinically significant chronic hematological disease - Anti-androgens, oral or injectable androgens - Cardiovascular conditions that prevent sexual activity |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | neuro-urology unit, Rambam Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus | Medispec |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IIEF-ED Domain score | Change of 5 points and above in IIEF-ED Domain score | 17 weeks after first visit | No |
Secondary | Rigidity scale | a change to 3 or 4 points in the rigidty scale | 17 weeks after first visit | No |
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