NCT05048667

Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction

Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Shock Wave therapy (SWT)	Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
DRUG	Platelet Rich Plasma (PRP)	5 mL PRP will be administered via intracavernous injection
OTHER	Sham SWT	Sham Shockwave Therapy will be administered in the sham arm.
OTHER	Placebo Saline	5 mL Placebo saline will be administered via intracavernous injection in the sham arm.

Timeline

• Start date: 2022-06-27
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2021-09-17
• Last updated: 2025-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study