Erectile Dysfunction Clinical Trial
— LI-ESWTOfficial title:
The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication
Verified date | December 2012 |
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 swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.
Status | Completed |
Enrollment | 29 |
Est. completion date | October 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus | Medispec |
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 from visit 1 | No |
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