CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 59 enrolled
Drug / intervention
Platelet Rich Plasma (PRP) +3 moredrug
Likely dose
Platelet Rich Plasma (PRP) 5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05048667
NCT05048667Phase 1Completed

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

University of Miami·interventional·Posted Sep 17, 2021·Updated May 22, 2026

In Brief

A Phase 1 clinical trial evaluating Shock Wave therapy (SWT), Platelet Rich Plasma (PRP), and 2 other interventions for Erectile Dysfunction. Completed, enrolled 59 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedSep 17, 2021
Enrollment StartJun 27, 2022
Primary CompletionMar 14, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.8 years ago

Interventions

Shock Wave therapy (SWT)device

Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.

Platelet Rich Plasma (PRP)drug

5 mL PRP will be administered via intracavernous injection

Sham SWTother

Sham Shockwave Therapy will be administered in the sham arm.

Placebo Salineother

5 mL Placebo saline will be administered via intracavernous injection in the sham arm.