Platelet Rich Plasma (PRP) as Terapeutical Option in Erectil Disfunction (DE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRP injection, Alprostadil 20 micrograms.
- Who it may be relevant to
- Registry conditions: Erectile Dysfunction Due to General Medical Condition, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Erectile Dysfunctions. Basic parameters: from 30 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug PRP injection
3 ML OF PRP - Drug Alprostadil 20 micrograms
1 ML
Primary outcome measures
- Change in erectile function [Time frame: 24 WEEKS]
Secondary outcome measures (12)
- EHS [Time frame: 24 WEEKS]
- 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]
- 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]
- 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]
- SEP [Time frame: 24 WEEKS]
- GAQ [Time frame: 24 WEEKS]
- QEQ [Time frame: 24 WEEKS]
- 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)]
- Change in TSS between PRP vs. prostaglandins [Time frame: 3 months after the end of the complete treatment]
- Change in SHIM [Time frame: 24 WEEKS]
- ECDPD - Peak Systolic Velocity (PSV) [Time frame: 24 WEEKS]
- ECDPD - Resistance Index (RI) [Time frame: 24 WEEKS]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- Policlinico di Bari - Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari
Identifiers
NCT: NCT06768177 · PRP vs CAVERJECT - 2023