Platelet-rich Plasma(PRP) Injection in ED

Not Applicable

• Conditions: Erectile Dysfunction; PRP
• Interventions: Biological: PRP

• Registration Number: NCT05241964
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-03-22
• Status Verified: 2021-09
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16
• Primary Completion: 2022-09-22
• Study Completion: 2022-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRP	PRP	PRP injection

Primary Outcome Measures

Name	Time	Method
International Index of Erectile Function(IIEF-5)	Change from 0 week at 4,8,12,24,48 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Erection Hardness Score(EHS)	Change from 0 week at 4,8,12,24,48 weeks	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; 1. Penis is larger, but not hard; 2. Penis is hard, but not hard enough for penetration; 3. Penis is hard enough for penetration, but not completely hard; 4. Penis is completely hard and fully rigid
Duplex - Peak systolic velocity(PSV)	0,16 weeks	To assess penile hemodynamics - Penile arterial blood velocity record (cm/s)
Duplex - Resistance index(RI)	0,16 weeks	To assess penile hemodynamics - Penile vascular resistance Index

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan