Erectile Dysfunction
Conditions
Brief summary
Purpose of Study: This randomized controlled trial investigates the role that platelet rich plasma injections into the penis may play to improve erectile function in men with erectile dysfunction.
Detailed description
Eligibility: Men with erectile dysfunction. Ages 50-80. International Index of Erectile Function score of mild (17-21/25) or moderate (8-16/25). Intervention and Evaluation:Men who consent to join the trial will be randomized to receive either a single injection PRP or saline to the penis. All patients will have blood drawn in clinic the day of injection. Those randomized to PRP arm will have their own blood prepared and separated into the PRP. This solution of their own blood will be injected back into the penis. Follow Up: Men will be evaluated at 1 , 3, and 6 months after the injections and then asked to complete the IIEF by phone or by electronic means
Interventions
BIOLOGICALPlatelet rich plasma
PRP will be used in the experimental arm.
sham injection
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* history of mild to moderate erectile dysfunction measured by IIEF
Exclusion criteria
* history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Function Change | at 1, 3 and 6 months | The rate of change in erectile function measured by IIEF |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | at 1, 3 and 6 months | any side effects noted by men |
Countries
United States
Outcome results
None listed