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

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: Male

Summary

Randomized, double-blind clinical trial to evaluate efficacy, feasibility and safety with two groups in a 1:1 ratio; where the control group corresponds to patients who will receive Platelet Poor plasma and an experimental group where patients will receive Platelet Rich Plasma, both collected by apheresis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puerta de Hierro University Hospital

Criteria

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.