Platelet-Rich Plasma Alone Versus PRP Plus Low-Intensity Shock Wave Therapy for Erectile Dysfunction

Effect of Platelet-Rich Plasma Injection Alone Versus Combined Platelet-Rich Plasma and Low-Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

Erectile dysfunction is a common condition that may result from vascular, neurological, hormonal, psychological, or medication-related factors. Platelet-rich plasma (PRP) and low-intensity extracorporeal shock wave therapy (Li-ESWT) are regenerative treatment approaches that may improve erectile function through mechanisms involving angiogenesis, tissue repair, and improvement of penile vascular function.

This randomized prospective study will compare the efficacy and safety of PRP injection alone with combined PRP injection and Li-ESWT in men with erectile dysfunction. A total of 80 participants will be randomly assigned to two groups. One group will receive PRP injections alone, while the other group will receive PRP injections combined with Li-ESWT. Participants will be followed after treatment to assess changes in erectile function, erection hardness, penile blood flow, patient satisfaction, and treatment-related adverse events.

The study hypothesis is that adding Li-ESWT to PRP therapy will result in greater improvement in erectile function than PRP therapy alone.

Inclusion Criteria:

• Male participants aged 30-65 years.
• Diagnosis of erectile dysfunction for at least 3 months.
• Mild to moderate erectile dysfunction, defined by an International Index of Erectile Function-5 (IIEF-5) score of 8-21.
• In a stable heterosexual relationship for at least 6 months.
• Sexually active, with at least one sexual attempt per week.

Exclusion Criteria:

• Severe erectile dysfunction, defined as IIEF-5 score <8.
• Primary psychogenic erectile dysfunction based on clinical history with or without psychosexual assessment.
• Anatomical penile abnormalities, including Peyronie's disease.
• History of radical pelvic surgery or pelvic radiotherapy.
• Uncontrolled diabetes mellitus, defined as HbA1c >9%.
• Uncontrolled hypertension, defined as blood pressure >160/100 mmHg.
• Recent myocardial infarction or stroke within the previous 6 months.
• Unstable angina.
• New York Heart Association class III-IV heart failure.
• Severe hepatic impairment.
• Severe renal impairment.
• Hypogonadism, defined as total testosterone <300 ng/dL.
• Hyperprolactinemia.
• Untreated thyroid disease.
• Current use of nitrates or nitric oxide donors.
• Current use of alpha-blockers, unless the participant is on a stable low dose.
• Current use of other phosphodiesterase type 5 inhibitors.