The purpose of this research study is to evaluate whether the combination of Shock Wave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function by improving vasodilation, and endothelial function
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
5 mL PRP will be administered via intracavernous injection
Sham Shockwave Therapy will be administered in the sham arm.
University of Miami Miller School of Medicine
Miami, Florida, United States
Change in IIEF-EF Scores
International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function.
Time frame: Baseline, Month 3, Month 6
Percentage of participants achieving MCID in IIEF-EF
IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. Mild Clinically Important Difference (MCID) is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.
Time frame: Baseline, Month 3, Month 6
Penile Blood Flow
Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography
Time frame: Baseline, Month 6
Circulating Angiogenic Factor levels
Circulating angiogenic factor levels including Vascular Endothelial Growth Factor (VEGF), Stromal Cell Derived Factor-1 (SDF-1 alpha) and Stem cell Factor (SCF), all reported in pg/mL, will be assessed via blood samples
Time frame: Baseline, Month 3, Month 6
Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors
The number of participants reporting a decrease or discontinue in use of PDE5 inhibitors will be reported
Time frame: Baseline, Month 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
5 mL Placebo saline will be administered via intracavernous injection in the sham arm.