Autologous PRP and Focal Shock Waves for Erectile Dysfunction

NCT06433596 | Recruiting

• 2 other identifiers: PRP-SW-032022-002985-34
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

Erectile Dysfunction

Keywords

Erectile dysfunction; Platelet-rich plasma; Shock wave therapy; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in IIEF-EF score

  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 Outcomes (8)

• Change in IIEF-EF score 1- month follow-up

  From enrollment to the first month of follow-up at 13 weeks

• Change in IIEF-EF score 6 months follow-up

  From enrollment to the sixth month of follow-up at 33 weeks

• Minimum clinically significant difference

  From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks

• Change in Erection Hardness Score (EHS)

  From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks

• Ability to penetrate

  From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks

Study Arms (4)

Autologous PRP

EXPERIMENTAL

3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves

Other: Platelet-rich plasma; Other: Sham shock waves therapy

Combined therapy

EXPERIMENTAL

3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.

Other: Platelet-rich plasma; Other: Shock waves therapy

Placebo control

PLACEBO COMPARATOR

3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves

Other: Placebo PRP; Other: Sham shock waves therapy

Shock waves

ACTIVE COMPARATOR

3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.

Other: Shock waves therapy; Other: Placebo PRP

Interventions

Placebo PRP OTHER

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

Placebo control; Shock waves

Sham shock waves therapy OTHER

6 sessions of sham shock waves, 1 per week

Also known as: Placebo therapy

Autologous PRP; Placebo control

Platelet-rich plasma OTHER

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

Also known as: PRP

Autologous PRP; Combined therapy

Shock waves therapy OTHER

6 sessions of focal shock waves, 1 per week

Combined therapy; Shock waves

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The participant must be male by biological sex and their gender identity must be male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Score of 4 on the EHS scale.
• Patients with an international normalized ratio (INR) greater than 3.
• Patients with sickle cell anemia.
• Patients with clinical suspicion of hypogonadism (ADAM positive).
• Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency.
• Active bladder, prostate, or colon cancer.
• Radical prostatectomy or other radical pelvic surgery.
• History of pelvic radiotherapy.
• Spinal cord injury or other neurological disease associated with erectile dysfunction.
• Penile anatomical dysfunction, penile implant.
• Platelet diseases or coagulation disorders.
• Treatment with oral anticoagulants.
• Platelet count outside the normal range (150 to 400 × 109/L).
• Patients with active infections or lesions of the penis or pubic area.
• Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics).

Sponsors & Collaborators

• Boston Medical Group: collaborator
• Elexial Research Limited: lead

Study Sites (1)

Boston Medical Group Spain S.L.U

Madrid, Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Jose Benitez, MD

  Boston Medical Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Sandoval, Master

CONTACT

0034 691336982; csandoval@bostonmedical.com.co

Héctor Corredor, MD

CONTACT

0034 691336982; hcorredor@bostonmedical.com.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 month after publication with no end date

Locations

ES (1)