Platelet-rich Plasma (PRP) Injection for Treatment of Erectile Function

Study Overview
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Brief Summary
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The primary objective of the present study is to investigate and compare the treatment efficacy of PRP injection vs placebo treatment in men with mild-moderate vasculogenic ED, as measured by IIEF.The secondary objective of the present clinical trial is to study the adverse events and safety of the PRP injection treatment in vasculogenic ED patients

Official Title
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The Effect of Platelet-rich Plasma(PRP) Injection Treatment on Erectile Function: a Double-blind, Placebo Controlled Randomized Clinical Trial

Conditions
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Erectile Dysfunction Due to Arterial Insufficiency

Intervention / Treatment
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* Biological: Platelet-Rich Plasma (PRP)
* Biological: Normal saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent to participate. Age 40-70 years. Sexually active in a stable, heterosexual relationship of more than three months duration. Presence of Erectile Dysfunction for at least 6 months. IIEF-ED: 11-25 at visit 1 PDE5i users and report some/good response to PDE5i at the last month before screening. Agree to suspend all ED therapy for the duration of the study. Agree to attempt sexual intercourse at least 4 times every 4 weeks, for the duration of the study without being under the influence of alcohol or recreational drugs. Agree to document the outcome using the Sexual Encounter Profile (SEP) diary, as needed. Exclusion Criteria: Previous major pelvic surgery or pelvic trauma that could impact erectile function, such as radical prostatectomy, radical cystectomy, rectal surgery. Patients with previous TURP surgery without sequelae of iatrogenic ED, may be included. 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 Previous radiation therapy to pelvis. 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. Peyronie's Disease or penile curvature that negatively influences sexual activity. Anatomical or neurological abnormalities in the treatment area. Any untreated medical condition (medical history) Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's Disease. Refusal to suspend ED therapy for duration of study. Subjects who are using Tadalafil as a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded. Men deemed not healthy enough to participate in sexual activity. Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits. Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in 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 SSRI or psychotropic medications. Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit participation in sexual intercourse. Patients with any hematological disorder.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br> | Biological: Platelet-Rich Plasma (PRP)<br>* All subjects of this group will receive 2 sessions of PRP penile injection with 30 +/- 3 day treatment interval, 10 ml of PRP will be injected at each session.<br>|
| Placebo Comparator: Group B<br> | Biological: Normal saline injection<br>* All subjects of this group will receive 2 sessions of normal saline penile injection with 30 +/- 3 day treatment interval for all subjects, 10 ml of normal saline will be injected at each session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % of patients in each group who attain Minimal Clinically Important Difference (MCID) in International Index of Erectile Function -Erectile Function (IIEF-EF) domain from baseline to 24 weeks after final treatment. | MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED at baseline and by 2 or more in the EF domain score of the IIEF for patients with moderate ED at baseline | at 24 weeks follow up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % of patients in each group who attain MCID in IIEF-EF domain from baseline to 12 weeks after final treatment. | MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED at baseline and by 2 or more in the EF domain score of the IIEF for patients with moderate ED at baseline | at 12 weeks follow up visit | 
| The % of patients in each group who attain MCID in IIEF-EF domain from baseline to 4 weeks after final treatment. | MCID is defined according to baseline ED severity as:Improvement by 5 or more in the EF domain score of the IIEF for patients with moderate ED at baseline and by 2 or more in the EF domain score of the IIEF for patients with moderate ED at baseline | at 4 weeks follow up visit | 
| The difference between the PRP group (2 sessions of PRP) and the placebo group in the change of the IIEF-ED score from baseline to 4 weeks after final treatment. | EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction). | baseline and 4 weeks follow up visit | 
| The difference between the PRP group (2 sessions of PRP) and the placebo group in the change of the IIEF-ED score from baseline to 12 weeks after final treatment. | EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction) | baseline and 12 weeks follow up visit | 
| The difference between the PRP group (2 sessions of PRP) and the placebo group in the change of the IIEF-ED score from baseline to 24 weeks after final treatment. | EF domain of the IIEF questionnaire will be completed.IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction) | baseline and 24 weeks follow up visit | 
| The difference between the PRP group (2 sessions of PRP) and the placebo group in the change in Sexual Encounter Profile Question 3 (SEP3) score from baseline to 4 weeks after final treatment. | The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported | baseline and 4 weeks follow up visit | 
| The difference between the PRP group (2 sessions of PRP) and the placebo group in the change in Sexual Encounter Profile Question 3 (SEP3) score from baseline to 12 weeks after final treatment. | The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported | baseline and 12 weeks follow up visit | 
| The difference between the PRP group (2 sessions of PRP) and the placebo group in the change in Sexual Encounter Profile Question 3 (SEP3) score from baseline to 24 weeks after final treatment. | The percent of subjects who answer ''YES'' in question 3 of SEP questionnaire will be reported | baseline and 24 weeks follow up visit | 
| The difference between the PRP group (2 sessions of PRP) and the placebo group in Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire score | EDITS is an 11-item validated questionnaire assessing treatment satisfaction. The 11 items in the EDITS questionnaire are combined into an index score by computing the mean of the 11 item scores and multiplying this value by 25. This results in an EDITS index score with a range of 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction) for an individual patient. | 4,12, 24 weeks follow up visit | 
| The difference between the PRP group (2 sessions of PRP) and the placebo group in the the Pain Visual Analogue Scale (VAS) after each injection treatment session | It will be assessed by the pain VAS, right after each LIST session. Pain VAS is a unidimensional measure of pain intensity . It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]. To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm | at week 0 and 4 | 
| Number of patients with treatment related adverse events | Potential treatment related adverse events after the first PRP injection session and during the 3 month follow up period will be reported | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRP, Platelet-Rich Plasma