Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)

Official Title
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A Randomized Control, Double-Blind, Placebo Controlled, Multicenter Clinical Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma Injection Treatment for Erectile Dysfunction.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Autologous Platelet Rich Plasma
* Other: Saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be Male Be 30 to 75 years of age (inclusive). Be able to provide written informed consent. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent. Sexually active in a stable, heterosexual relationship of more than three months duration. IIEF-EF score 11-25 at screening (even if taking a single PDE5). Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs. Agree to comply with all study related tests/procedures. Exclusion Criteria: Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting. Previous history of priapism or penile fracture Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%). Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded. Psychogenic ED as determined by study investigator. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area. Patients using Intra Cavernous Injection (ICI)for management of ED Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study. History of consistent treatment failure with PDE5 inhibitors for therapy of ED. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitor or psychotropic medications. Hemoglobin a1c >9%.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP group<br>Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days | Drug: Autologous Platelet Rich Plasma<br>* Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.<br>* Other names: PRP;|
| Placebo Comparator: Placebo group<br>Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days. | Other: Saline solution<br>* Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL s each injected to the right and left corpus cavernosum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving MCID in IIEF-EF | Treatment efficacy of PRP will be assessed via the percentage of participants achieving mild clinically important difference (MCID) in their IIEF-EF scores from baseline to 4 weeks after final treatment. International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED. | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving MCID in IIEF-EF | Treatment efficacy of PRP will be assessed via the percentage of participants achieving MCID in their IIEF-EF scores from baseline to 2 and 24 weeks after final treatment. IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED. | 24 weeks | 
| Change in IIEF-EF Scores | IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function. | Baseline up to Week 9, Baseline up to Week 17, Baseline up to Week 29 | 
| Change in doppler ultrasound parameters | Change in Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) assessed in cm/sec via ultrasound. | Baseline, Up to 29 weeks | 
| Incidence of adverse events | Safety will be evaluated via the incidence of adverse events as assessed by treating physician | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ED