By InvitationNot Applicable

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

Italy60 participantsStarted 2023-04-01

Plain-language 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.

Who can participate

Age range30 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in erectile function

Timeframe: 24 WEEKS

Trial details

NCT IDNCT06768177

SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

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