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Autologous PRP and Focal Shock Waves for Erectile Dysfunction

NCT06433596 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-05-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Platelet-rich plasma (PRP) combined with Shock-wave therapy (SWT) works to treat moderate or mild to moderate erectile dysfunction. It will also learn about the safety of this combined therapy.

The main questions it aims to answer are:

* Does Combined therapy PRP + SWT improve erection in men with moderate or mild to moderate erectile dysfunction?
* What medical problems do participants have when receiving Combined therapy PRP + SWT?

Researchers will compare Combined therapy PRP + SWT to placebo therapy (a look-alike substance that contains no PRP) to see if Combined therapy PRP + SWT works to treat moderate or mild to moderate erectile dysfunction.

Participants will:

* Take a lab test to evaluate their platelets
* Answer some questionnaires to assess your erectile function
* Receive Combined therapy PRP + SWT (3 sessions PRP + 6 sessions SWT) or placebo therapy for 9 weeks
* Visit the clinic one month, 3 months, and 6 months after finishing the treatment for checkups and tests

Conditions

Interventions

OTHER

Platelet-rich plasma

3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9

OTHER

Shock waves therapy

6 sessions of focal shock waves, 1 per week

OTHER

Placebo PRP

3 injections of 10 cc of saline solution, weeks 1, 5 and 9

OTHER

Sham shock waves therapy

6 sessions of sham shock waves, 1 per week

Sponsors & Collaborators

  • Boston Medical Group

    collaborator INDUSTRY

  • Elexial Research Limited

    lead OTHER

Principal Investigators

  • Jose Benitez, MD · Boston Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2026-08-31
Completion
2027-02-28

Countries

  • Spain

Study Locations

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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 NCT06433596 on ClinicalTrials.gov