Platelet-rich Plasma(PRP) Injection in ED

Study Overview
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Brief Summary
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RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. In theory, it is possibility of curing ED.

Detailed Description
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There are many reasons of erectile dysfunction(ED). If left untreated, there is a major impact on relationships, self-esteem, and overall health. RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. Its mechanism is to promote the regeneration of blood vessels in the cavernous body of the penis, increase blood circulation, and then help erection, increase penile stiffness and improve the phenomenon of premature ejaculation. The main purpose of this study is to study the safety and effectiveness of PRP injection for the treatment of ED.

Official Title
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A Prospective Trial of Autologous Platelet-rich Plasma Injection in Erectile Dysfunction Treatment

Conditions
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Erectile Dysfunction, PRP

Intervention / Treatment
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* Biological: PRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Between 20 and 70 years old Sexual dysfunction exists for at least 6 months IIEF-5 score 8-2 Sign an informed consent form Exclusion Criteria: Ever radical prostatectomy or extensive pelvic surgery Radiation therapy to the pelvic area within 12 months before recruiting Cancer Nervous system diseases that affect erectile function Have any blood disease History of coronary artery disease

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>PRP injection | Biological: PRP<br>* 4 6ml autologous platelet rich plasma injection every 14±2 days for a total of 5 injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function(IIEF-5) | The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild (12-21), and no ED (22-25). | Change from 0 week at 4,8,12,24,48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erection Hardness Score(EHS) | EHS can be a helpful tool to evaluate ED - a man's inability to get or maintain an erection firm enough for sex. To select one of the following options: 0 Penis does not enlarge Penis is larger, but not hard Penis is hard, but not hard enough for penetration Penis is hard enough for penetration, but not completely hard Penis is completely hard and fully rigid | Change from 0 week at 4,8,12,24,48 weeks | 
| Duplex - Peak systolic velocity(PSV) | To assess penile hemodynamics - Penile arterial blood velocity record (cm/s) | 0,16 weeks | 
| Duplex - Resistance index(RI) | To assess penile hemodynamics - Penile vascular resistance Index | 0,16 weeks |