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

NCT04502875 | Unknown Phase 2 DMC

• 1 other identifier: PRePED
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Keywords

Platelet Rich Plasma; Platelet Poor Plasma

Outcome Measures

Primary Outcomes (1)

• Difference of increments between PRP and PPP treatment assessed by IIEF scale

  Difference of increments between both treatment groups assesed by International Index Erectile Function (IIEF) scale (referred to the investigator's study as mean PRP V9(PT)IIEF-EF - V3IIEF-EF vs mean PPP V9(PT)IIEF-EF - V3IIEF-EF) after 4 weeks of the end of the treatment.

  28 weeks

Secondary Outcomes (3)

• Incidence of adverse events related with the use of PRP/PPP

  28 weeks

• Synergic efficcacy of PRP and PDE5 inhibitors

  28 weeks

• Concentration of cytokines and growth factors in the PRP and PPP

  28 weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Intracavernosal infusion of Platelet Rich Plasma

Drug: PRP

Control Arm

ACTIVE COMPARATOR

Intracavernosal infusion of Platelet Poor Plasma

Drug: PPP

Interventions

PRP DRUG

Platelet Rich Plasma (PRP) is an autologous blood component derivate from the own patient blood, with a high concentration in platelets. The liquid fraction obtained after the soft centrifugation of Whole Blood (WB) collected with anticoagulant, in a way that most of the red cells and leukocytes are sedimented and removed, but most of the platelets are kept in the supernatant plasma. The platelet concentration in PRP is not well defined.

Treatment Arm

PPP DRUG

PPP is the liquid fraction obtained after the hard centrifugation of WB collected with any anticoagulant. PPP does not contain cells. (Hematocrit lower than 1% and leukocytes below 1 x 109/L) x but contains WB proteins (including clotting factors), ions, microelements and water. PPP can be also being collected using an apheresis technique.

Control Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed an ethics committee-reviewed and approved informed consent form.
• 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.
• 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.

You may not qualify if:

• 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%).
• 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).

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Puerta de Hierro University Hospital

Majadahonda, Madrid, 28222, Spain

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Juan Martinez-Salamanca, Md, PhD

  Urologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Ignacio Martínez-Salamanca, MD, PhD

CONTACT

+34 91 191 71 95; jims@lyxurologia.com

Gustavo Centeno, MD, PhD

CONTACT

91 191 6026; gustavoadolfo.centeno@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 PPP and an experimental group where patients will receive PRP, both collected by apheresis.

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: August 6, 2020
• Study Start: February 10, 2020
• Primary Completion: February 28, 2022
• Study Completion: August 31, 2022
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)