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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Invitation-only

Conditions: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunctions; Erectile Dysfunction Due to General Medical Condition

Treatments: Drug: Alprostadil 20 micrograms; Drug: PRP injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06768177

PRP vs CAVERJECT - 2023

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

TREATMENT ARM

Experimental group

Description:

3 ML OF PRP

Treatment:

Drug: PRP injection

COMPARISON ARM

Placebo Comparator group

Description:

CAVERJECT 1 ML

Treatment:

Drug: Alprostadil 20 micrograms