Clinical trial NCT06768177: Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)
Official title: Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Erectile Dysfunction Due to General Medical Condition
Erectile Dysfunction Following Radical Prostatectomy
Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Erectile Dysfunctions
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in erectile function
timeFrame: 24 WEEKS
Secondary outcomes:
measure: EHS
timeFrame: 24 WEEKS
measure: The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP
timeFrame: 24 WEEKS
measure: The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin
timeFrame: 24 WEEKS
measure: The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.
timeFrame: 24 WEEKS
measure: SEP
timeFrame: 24 WEEKS
measure: GAQ
timeFrame: 24 WEEKS
measure: QEQ
timeFrame: 24 WEEKS
measure: Change in EDITS between PRP vs. prostaglandins
timeFrame: At T1 (2 weeks after the end of the first cycle) and T2 (2 weeks after the end of the second cycle)
measure: Change in TSS between PRP vs. prostaglandins
timeFrame: 3 months after the end of the complete treatment
measure: Change in SHIM
timeFrame: 24 WEEKS
measure: ECDPD - Peak Systolic Velocity (PSV)
timeFrame: 24 WEEKS
measure: ECDPD - Resistance Index (RI)
timeFrame: 24 WEEKS
measure: ECDPD - End-Diastolic Velocity (EDV)
timeFrame: 24 WEEKS
measure: Adverse events
timeFrame: 24 WEEKS
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico
Study officials:
References: