MCID (Minimal Clinically Important Differences) is defined on the severity of ED at baseline as:

• An improvement of 5 or more points in the IIEF score for patients with moderate ED (8-11) at baseline
• An improvement of 2 or more points

The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.

Change in SEP:

• Response to questions 2 and 3 (SEP-Q2: Were you able to insert your penis into your partner's vagina? / SEP-Q3: Did your erection last long enough to allow you to have successful intercourse?)
• Change from baseline (= "YES" response) o At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)

Response to GAQ questions 1 and 2 (GAQ-Q1: Has the treatment you are taking improved your erectile function? / GAQ-Q2: If yes, has the treatment improved your ability to engage in sexual activity?) Change at T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) o Change from baseline (= "YES" response)

At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment) o Improvement of 2 or more in the score

At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle)

Change in TSS between PRP vs. prostaglandins at T3 (3 months after the end of the complete treatment)

Change in SHIM

• At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
• Improvement of 2 or more points in the score

ECDPD - Peak Systolic Velocity (PSV):

• To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
• Recording of arterial penile velocity (cm/s) o Improvement in cm/s (any > 30 cm/s)

ECDPD - Resistance Index (RI):

• To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
• Penile vascular resistance index (ratio) o Improvement (any increase up to the normal value - 0.9)

ECDPD - End-Diastolic Velocity (EDV):

• To assess penile hemodynamics from baseline to T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)
• Recording of residual flow in a vessel at the end of the diastolic phase (cm/s)
• Improvement in cm/s (any decrease in cm/s)

Adverse events: Number of participants who experienced treatment-related adverse events.

Defined as: skin reaction (e.g., swelling, erythema, and warmth), discomfort at the injection site, penile pain, change in penile appearance, new sexual problems, and any systemic reaction observed by investigators or concerns expressed by patients o At T1 (2 weeks after the end of the first cycle), T2 (2 weeks after the end of the second cycle), and T3 (3 months after the end of the complete treatment)