Autologous PRP and Focal Shock Waves for Erectile Dysfunction

May 7, 2026 updated by: Elexial Research Limited

Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this clinical trial is to evaluate the effectiveness of intracavernosal autologous platelet-rich plasma therapy, compared with placebo, for the treatment of moderate or mild to moderate erectile dysfunction, measured as improvement in the IIEF-EF questionnaire score.

Study design: Randomized, double-blind, placebo-controlled clinical trial, phase III. The study will include four groups:

  • G1 - Autologous PRP: Autologous Platelet Rich Plasma (PRP) + placebo shock waves
  • G2 - combined therapy: Autologous PRP + focal shock waves
  • G3 - placebo control: Placebo PRP + placebo shock waves

  • G4 - shock waves: PRP placebo + shock waves

    116 subjects will be included, who will be randomized in a 1:1:1:1 ratio in the four groups described above.

The change in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) score, the change in the Erection Hardness Score (EHS), and the adverse events will be evaluated at the end of treatment, and 1, 3, and 6 months of follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Boston Medical Group Spain S.L.U

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Men over 18 years of age.
  2. Erectile dysfunction present for more than 3 months in more than 50% of intercourse.
  3. Baseline score of the IIEF-EF questionnaire between 11 and 21.
  4. Stable heterosexual relationship of at least 6 months.
  5. Commitment to have at least 3 vaginal sexual relations per month after completing treatment.
  6. Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
  7. A patient who agrees to voluntarily enter the study by signing an informed consent.

Exclusion Criteria:

  1. Score of 4 on the EHS scale.
  2. Patients with an international normalized ratio (INR) greater than 3.
  3. Patients with sickle cell anemia.
  4. Patients with clinical suspicion of hypogonadism (ADAM positive).
  5. Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency.
  6. Active bladder, prostate, or colon cancer.
  7. Radical prostatectomy or other radical pelvic surgery.
  8. History of pelvic radiotherapy.
  9. Spinal cord injury or other neurological disease associated with erectile dysfunction.
  10. Penile anatomical dysfunction, penile implant.
  11. Platelet diseases or coagulation disorders.
  12. Treatment with oral anticoagulants.
  13. Platelet count outside the normal range (150 to 400 × 109/L).
  14. Patients with active infections or lesions of the penis or pubic area.
  15. Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics).
  16. Patients with erectile dysfunction of psychological origin.
  17. Abuse of psychoactive substances (including alcohol).
  18. Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls.
  19. Inability to attend therapies and controls.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Autologous PRP
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves
Other: Platelet-rich plasma
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
Other Names:
  • PRP
Other: Sham shock waves therapy
6 sessions of sham shock waves, 1 per week
Other Names:
  • Placebo therapy
Experimental: Combined therapy
3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.
Other: Platelet-rich plasma
3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
Other Names:
  • PRP
Other: Shock waves therapy
6 sessions of focal shock waves, 1 per week
Placebo Comparator: Placebo control
3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves
Other: Sham shock waves therapy
6 sessions of sham shock waves, 1 per week
Other Names:
  • Placebo therapy
Other: Placebo PRP
3 injections of 10 cc of saline solution, weeks 1, 5 and 9
Active Comparator: Shock waves
3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in IIEF-EF score
Time Frame: From enrollment to the third month of follow-up at 21 weeks
Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline and week 21 (3 months after completion of treatment)
From enrollment to the third month of follow-up at 21 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in IIEF-EF score 1- month follow-up
Time Frame: From enrollment to the first month of follow-up at 13 weeks
Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline measurement and measurement at week 13
From enrollment to the first month of follow-up at 13 weeks
Change in IIEF-EF score 6 months follow-up
Time Frame: From enrollment to the sixth month of follow-up at 33 weeks
Change in IIEF-EF score between baseline measurement and measurement at week 33
From enrollment to the sixth month of follow-up at 33 weeks
Minimum clinically significant difference
Time Frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points)
From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Change in Erection Hardness Score (EHS)
Time Frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Change in EHS between baseline measurement and measurement at weeks 13, 21, and 33
From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Ability to penetrate
Time Frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Proportion of patients who accomplish to penetrate after treatment, evaluated by the change in the EHS from 1 or 2 at baseline to 3 or 4 in weeks 13, 21 and 33.
From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Quality of sexual life
Time Frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Change in the score of the sexual quality of life questionnaire (SLQQ) between the baseline measurement and the measurement at weeks 13, 21 and 33.
From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Global assessment
Time Frame: From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Change in the score of the global assessment questionnaire (GAQ) at weeks 13, 21 and 33.
From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
Adverse events incidence
Time Frame: From the first intervention to end of follow-up at 33 weeks
Incidence of PRP-related adverse events during the study
From the first intervention to end of follow-up at 33 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elexial Research Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Medical Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose Benitez, MD, Boston Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRP-SW-03
  • 2022-002985-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data (IPD) collected throughout the trial, except personal identification data of the participants

IPD Sharing Time Frame

Beginning 1 month after publication with no end date

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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