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

NCT05048667 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-05-22

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Miami

    lead OTHER

Principal Investigators

  • Emad Ibrahim, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2025-03-14
Completion
2025-03-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05048667 on ClinicalTrials.gov