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

Not Applicable

• Conditions: Erectile Dysfunction Due to General Medical Condition; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Associated With Type 2 Diabetes Mellitus; Erectile Dysfunctions
• Interventions: Drug: PRP injection; Drug: Alprostadil 20 micrograms

• Registration Number: NCT06768177
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2024-04
• Primary Completion: 2024-11-01
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TREATMENT ARM	PRP injection	3 ML OF PRP
COMPARISON ARM	Alprostadil 20 micrograms	CAVERJECT 1 ML

Primary Outcome Measures

Name	Time	Method
Change in erectile function	24 WEEKS	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

Secondary Outcome Measures

Name	Time	Method
EHS	24 WEEKS	Time frame: change from baseline and at 8 weeks, 16 weeks, and 24 weeks Any value above 0 (0 = The penis does not enlarge)
The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP	24 WEEKS	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
The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin	24 WEEKS	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.	24 WEEKS	The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.
SEP	24 WEEKS	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)
GAQ	24 WEEKS	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)
QEQ	24 WEEKS	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
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	3 months after the end of the complete treatment	Change in TSS between PRP vs. prostaglandins at T3 (3 months after the end of the complete treatment)
Change in SHIM	24 WEEKS	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)	24 WEEKS	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)	24 WEEKS	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)	24 WEEKS	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	24 WEEKS	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)

Trial Locations

Locations (1)

Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico; 🇮🇹 Bari, Italy