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Enrolling by Invitation

NCT Number: NCT06768177

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.

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Key information

Conditions

Erectile Dysfunction Due to General Medical Condition Erectile Dysfunction Erectile Dysfunction Associated With Type 2 Diabetes Mellitus Erectile Dysfunction Following Radical Prostatectomy Erectile Dysfunctions Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP injection

Drug

3 ML OF PRP

Alprostadil 20 micrograms

Drug

1 ML

Primary outcomes

  1. Change in erectile function

    Time frame: 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 outcomes

  1. EHS

    Time frame: 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)

  2. The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with PRP

    Time frame: 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

  3. The percentage of patients in each group who achieve MCID in the IIEF-EF domain from baseline after treatment with prostaglandin

    Time frame: 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

  4. 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

    The difference in the IIEF score from baseline to the end of treatment between the PRP group and the prostaglandin-treated group.

  5. SEP

    Time frame: 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)

  6. GAQ

    Time frame: 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)

  7. QEQ

    Time frame: 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

  8. Change in EDITS between PRP vs. prostaglandins

    Time frame: 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)

  9. Change in TSS between PRP vs. prostaglandins

    Time frame: 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)

  10. Change in SHIM

    Time frame: 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

  11. ECDPD - Peak Systolic Velocity (PSV)

    Time frame: 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)

  12. ECDPD - Resistance Index (RI)

    Time frame: 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)

  13. ECDPD - End-Diastolic Velocity (EDV)

    Time frame: 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)

  14. Adverse events

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 10, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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