Patients are randomized into 2 groups (A and B), subsequently group A is subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP while group B is subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg. After 4 (four) weeks the groups will be crossed, so group A will be subjected to 6 weekly injections of 1 ml of caverject (alprostadil) 20 mcg while group B will be subjected to a cycle of 6 weekly injections of 3 ml of autologous PRP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
3 ML OF PRP
1 ML
Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Italy
Change in erectile function
Change in erectile function defined as the % of patients in each group achieving MCID in the IIEF-EF domain from baseline to 24 weeks (i.e. 12 weeks after the end of full treatment): * MCID (Minimal clinically important differences) is based on the severity of ED at baseline as: * Improvement of 5 or points more in IIEF score for patients with moderate ED (8-11) at baseline * Improvement of 2 or more points in IIEF score for patients with severe ED (5-7) at baseline
Time frame: 24 WEEKS
EHS
Time frame: change from baseline and at 8 weeks, 16 weeks, and 24 weeks Any value above 0 (0 = The penis does not enlarge)
Time frame: 24 WEEKS
The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP
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 in the IIEF score for patients with severe ED (5-7) at baseline
Time frame: 24 WEEKS
The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin
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
Time frame: 24 WEEKS
The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.
The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.
Time frame: 24 WEEKS
SEP
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)
Time frame: 24 WEEKS
GAQ
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)
Time frame: 24 WEEKS
QEQ
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
Time frame: 24 WEEKS
Change in EDITS between PRP vs. prostaglandins
At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle)
Time frame: 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
Change in TSS between PRP vs. prostaglandins at T3 (3 months after the end of the complete treatment)
Time frame: 3 months after the end of the complete treatment
Change in SHIM
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
Time frame: 24 WEEKS
ECDPD - Peak Systolic Velocity (PSV)
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)
Time frame: 24 WEEKS
ECDPD - Resistance Index (RI)
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)
Time frame: 24 WEEKS
ECDPD - End-Diastolic Velocity (EDV)
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)
Time frame: 24 WEEKS
Adverse events
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)
Time frame: 24 WEEKS
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