Using PRP and Shock Waves to Treat Erectile Dysfunction

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

This study is testing if a new treatment that combines platelet-rich plasma therapy with shock wave therapy can help men with mild to moderate erectile dysfunction feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Elexial Research Limited (Academic / other)
• Locations: 1 site (Madrid)
• Trial ID: NCT06433596 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of combining autologous platelet-rich plasma (PRP) therapy with focal shock wave therapy (SWT) for treating men with moderate or mild to moderate erectile dysfunction. Participants will be randomly assigned to receive either the combined therapy or a placebo, and their erectile function will be assessed using standardized questionnaires. The study will monitor the safety and efficacy of the treatment over a period of 9 weeks, with follow-up evaluations at 1, 3, and 6 months post-treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are men over 18 years old with moderate or mild to moderate erectile dysfunction lasting more than 3 months.

Not a fit: Patients with severe erectile dysfunction or certain medical conditions such as active cancer or hormonal deficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for men suffering from erectile dysfunction.

How similar studies have performed: Other studies have shown promise in using similar approaches, but this specific combination of therapies is relatively novel.

Eligibility criteria

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.

Where this trial is running

Madrid

• Boston Medical Group Spain S.L.U — Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: Jose Benitez, MD — Boston Medical Group
• Study coordinator: Carolina Sandoval, Master

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