Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction

Clinical Randomized Multicentric Trial to Evaluate the Comparative Effectiveness and Safety of Three Protocols Using Low-intensity Shock Waves for the Treatment of Erectile Dysfunction

The patients with primary erectile dysfunction (IIEF-EF <26 points), will be randomly assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week; Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality of life will also be evaluated using the SEAR scale.

Inclusion Criteria:

• Men over 18 years of age
• Presence of ED for more than 3 months in over 50% of sexual intercourses.
• Baseline ED domain score under 26 on the IIEF-15 EF domain.
• Patient agrees to participate in the trial by providing signed informed consent.

Exclusion Criteria:

• EHS score of 4.
• Patients with an INR over 3.
• Patients with sickle-cell anemia.
• Patients with clinical suspicion of hypogonadism (AMS over 36).
• Endocrine diseases that present with ED, such as acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency.
• Active vesicular, prostrate or colon cancer.
• Radical prostatectomy or other radical pelvic surgery.
• History of pelvic radiation therapy.
• Patients with ED of psychological origin.
• Spinal cord injury or other neurological diseases associated with ED.
• Anatomical penile dysfunction, penile implant.
• Patients with active infections or lesions on the penis or pubic area.
• Patients with ED secondary to drug therapy (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, medication for Parkinson's disease, antipsychotics).
• Abuse of psychoactive substances.