Clinical Trial to Evaluate the Efficacy of Intracavernosal Infusion of PRP vs PPP for the Erectile Dysfunction. (PRePED)

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Platelet Rich Plasma, Platelet Poor Plasma Read More

Inclusion Criteria:

• Signed an ethics committee-reviewed and approved informed consent form.
• Subjects must meet all inclusion criteria to be eligible for study enrollment.
• Men between 40 and 75 years old, with a relationship of more than 6 months of duration.
• 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.
• Erectile dysfunction of vascular origin. In case of clinical doubt or incongruence, a Nocturnal Penile Tumescence and Rigidity Test (NPTR) will be performed. In this case, criteria inclusion is having no event in the night with a penile rigidity (tip) of ≥70% during ≥5min.
• Subjects agree to attempt vaginal intercourse at least 4 times every month after the end of the treatment and agree to document the outcome using the Sexual Encounter Profile (SEP) and the Erection Hardness Score (EHS).
• Commitment not to use other treatment for ED during the study (herbal, topical, intraurethral, intracavernosal, etc.).
• Commitment to completing the rest of the questionnaires and other measurement instruments during the study phase.
• Willingness and ability to comply with study procedures, other measurements instruments and visit schedules and able to follow oral and written instructions.

Exclusion Criteria:

• Documented psychogenic erectile dysfunction (with NPTR test: at least one event in the night with a penile rigidity (tip) of ≥70% during ≥5min).
• Erectile dysfunction of neurogenic origin (radical prostatectomy, pelvic surgery, spinal cord injury, multiple sclerosis, diabetes mellitus is not included unless documented diabetic neuropathy).
• Some other current sexual dysfunction (premature ejaculation, etc.).
• Prior implant of penile prosthesis or other penile surgeries different to circumcision, frenuloplasty or condyloma removal.
• Previous history of penile fracture, Peyronie's disease or priapism.
• History of radical prostatic or bladder surgery (radical cystectomy or prostatectomy).
• Previous radiation to pelvis.
• History of symptomatic hypogonadism (testosterone level <346ng/dl) not treated. If treated hypogonadism, testosterone levels non-stable for at least 3 months.
• Major hematologic, renal, or hepatic abnormalities.
• Severe decompensated cardiac and vascular insufficiency, or critical coronary heart disease.
• Poorly controlled hypertension or diabetes mellitus (HbA1c >12%).
• Recent (within previous six months of the inclusion) stroke or myocardial infarction.
• Active peptic ulcer disease.
• Neoplasm of any origin in active treatment or active progression.
• History of psychiatric pathology (depressive syndrome, schizophrenia, bipolar disorder).
• History of alcohol abuse (More than 7 alcohol drink units 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).
• Treatment with oral anticoagulants (dicoumarin or by-products) or antiandrogens.
• Active treatment as nitric oxide (NO) donor drugs.
• Prior positive serology to HBsAg, HCV (by genomic test), HIV-1/2, syphilis.
• Thrombopenia less than 100 x 109 / L.
• Anemia (Hemoglobin <13 g/dl).
• Poor venous access or any other circumstance that preclude an apheresis procedure.
• Lack of sexual practices in recent months (less than 4 attempts in the last three months).
• Lack of commitment on the part of the patient to attend the tests requested.