Vascular Erectile Dysfunction MedDRA version: 20.0 Level: PT Classification code 10061461 Term: Erectile dysfunction System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Platelet Rich Plasma
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Platelet rich plasma
Other descriptive name: AUTOLOGOUS PLASMA
Concentra
Sponsors
Fundación de Investigación Biomédica Hospital Puerta de Hierro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects must meet all inclusion criteria to be eligible for study enrollment. 2. Men between 40 and 75 years old, with a relationship of more than 6 months of duration. 3. Erectile dysfunction for at least 6 months with an IIEF-EF (while using the higher tolerated dose of PDE5-Is) between 5 and 16 points, inclusive. 4. Erectile dysfunction of vascular origin. This will be determined by clinical history and pathological intracavernosal vasoactive testing (E0-E3 after 15-30 minutes of ICI of alprostadil 20mcg). In case of doubtful results (E4-E5 after 15-30 minutes of ICI of alprostadil 20mcg), a pathological Doppler ultrasound (PSV =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: 1. Documented psychogenic erectile dysfunction (with NPTR test: at least one event in the night with a penile rigidity (tip) of =70% during =5min). 2. Erectile dysfunction of neurogenic origin (radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, diabetes mellitus is not included unless documented diabetic neuropathy). 3. Some other current sexual dysfunction (premature ejaculation, etc.). 4. Prior implant of penile prosthesis or other penile surgeries different to circumcision, frenuloplasty or condyloma removal. 5. Previous history of penile fracture, Peyronie’s disease or priapism. 6. History of radical prostatic or bladder surgery (radical cystectomy or prostatectomy). 7. Previous radiation to pelvis. 8. History of symptomatic hypogonadism (testosterone level 12%). 12. Recent (within previous six months of the inclusion) stroke or myocardial infarction. 13. Active peptic ulcer disease 14. Neoplasm of any origin in active treatment or active progression. 15. History of psychiatric pathology (depressive syndrome, schizophrenia, bipolar disorder). 16. History of alcohol abuse (More than 7 alcohol units drink a week or more than 3 per occasion) or drug abuse (any drug consumption different to alcohol or tobacco, used more than three times per month). 17. Treatment with oral anticoagulants (dicoumarin or by-products) or antiandrogens. 18. Active treatment as nitric oxide (NO) donor drugs. 19. Prior positive serology to HBsAg, HCV (by genomic test), HIV-1/2, syphilis. 20. Thrombopenia less than 100 x 109 / L. 21. Anemia (Hemoglobin <13 g/dl). 22. Poor venous access or any other circumstance (e.g. virological results) that preclude an apheresis procedure. 23. Lack of sexual practices in recent months (less than 4 attempts in the last three months). 24. Lack of commitment on the part of the patient to attend the tests requested.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of intracavernous injection of leukodeplected PRP collected by apheresis and stored as platelet lysate in the treatment of vascular erectile dysfunction in comparison to PPP measured by the improved in the IIEF-EF score after 28 weeks.;Secondary Objective: - To evaluate the clinical safety of intracavernous injection of leukodeplected PRP collected by apheresis and stored as platelet lysate, in the treatment of vascular erectile dysfunction - To determine the synergic efficacy of leukodeplected PRP collected by apheresis and stored as platelet lysate on the therapeutic response to oral administration of PDE5 inhibitors. - To analyze the cytokines and growth factors concentration (EGF, FGF-2, IFN gamma, IL-6, IL-10, TNF-alfa, VEGFA, TGF-beta1, IGF-1, PDGF-BB, GDF-11 and IL- 8) in the PRP and PPP of each patient and their relationship with the clinical response to PRP.;Primary end point(s): The main planned analysis will compare difference increments between both treatment groups (referred to our study as PRP V9(PT) IIEF-EF- V3IIEF-EF vs PPP V9(PT)IIEF-EF - V3IIEF-EF) after 4 weeks of the end of the treatment.;Timepoint(s) of evaluation of this end point: 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The adverse events incidence related to apheresis and PRP and PPP infusion during the study period. 2. The percentage of patients in each group who achieve a minimal clinical difference (5 or 7 points, depending of baseline grade of ED, in the IIEF-EF between V9(PT) and V3. 3. The percentage of patients in each group who achieve a minimal clinical difference (5 or 7 points in the IIEF-EF between V10 and V1-baseline) at 8 weeks after the end of the treatment. 4. The percentage of patients in each group who achieve a minimal clinical difference (5 or 7 points in the IIEF-EF between V11a and V3) at 16 weeks after the end of the treatment. 5. The percentage of patients in each group who achieve a minimal clinical difference (5 or 7 points in the IIEF-EF between V12a and V3) at 28 weeks after the end of the treatment. 6. The change of the other domains of IIEF questionnaire (orgasmic function, sexual desire, intercourse satisfaction, overall satisfaction) from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment. 7. The change of the Global Assessment Questionnaire (GAQ 1 and 2) from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment. 8. The change of the Sexual Encounter Profile Questions 2 and 3 (SEP 2 and SEP3, MCID=21.4% and 23%, respectively)) from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment. 9. The percentage of patients who achieve MCID in the Erection Hardness Score (EHS, MCID=1) from baseline to 4, 8 (V10 vs V1), 16 and 28 weeks after the end of the treatment. 10. The change of the Peak Systolic Velocity (PSV) of the cavernosal arteries from baseline to 28 weeks after the end of the treatment. 11. The percentage of patients who achieve a positive intracavernosal vasoactive test from baseline to 28 weeks after the end of the treatment. 12. The difference between the two groups in the change of the girth and length of the stretched flaccid and erected peni | — |
Countries
Spain
Contacts
Public ContactGustavo Adolfo Centeno Soto
Servicio de Farmacología Clínica. Hospital Universitario Puerta de Hierro Majadahonda
Outcome results
None listed