Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)

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 Overview

• Status: Enrolling by invitation
• Conditions: Erectile Dysfunctions; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Due to General Medical Condition; Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: PRP injection; Drug: Alprostadil 20 micrograms

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Moderate to severe erectile dysfunction (IIEF-5 score below 17)
• Patients previously treated with first- and second-line therapies for ED
• Patients who have undergone radical pelvic surgery with nerve sparing
• Good pharmacological blood pressure control
• Well-controlled diabetes on medication
• Current or former smokers
• Good renal function even with the use of medications
• Well-controlled hypertriglyceridemia and/or hypercholesterolemia even with the use of medications
• BMI less than or equal to 35
• Normal levels of FSH, LH, PRL, Total Testosterone, and TSH

Exclusion Criteria:

• Patients on antidepressant, anxiolytic, sedative, or antipsychotic medications.
• Consumers of more than 500 g of alcohol per day.
• BMI greater than 35
• Altered levels of FSH, LH, PRL, Total Testosterone, and TSH.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TREATMENT ARM; 3 ML OF PRP	Drug: PRP injection; 3 ML OF PRP
Placebo Comparator: COMPARISON ARM; CAVERJECT 1 ML	Drug: Alprostadil 20 micrograms; 1 ML

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 WEEKS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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.	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)	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)	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	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)	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)	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	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)	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)	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)	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)	24 WEEKS

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction; Platelet Aggregation Inhibitors; Vasodilator Agents; Urological Agents; Alprostadil
• Other Study ID Numbers: PRP vs CAVERJECT - 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No