Autologous PRP and Focal Shock Waves for Erectile Dysfunction

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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).
• Patients with erectile dysfunction of psychological origin.
• Abuse of psychoactive substances (including alcohol).
• Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls.
• Inability to attend therapies and controls.