Platelet-rich Plasma(PRP) Injection in ED

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05241964
• Other study ID #: 202008061RIPC
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: November 29, 2022

Study information

• Verified date: September 2021
• Source: National Taiwan University Hospital
• Contact: I-Ni Chiang, MD
• Phone: +886919077219
• Email: inichiang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 29, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• PRP

Intervention

Biological:
• PRP
4~6ml autologous platelet rich plasma injection every 14±2 days for a total of 5 injections.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duplex - Peak systolic velocity(PSV)	To assess penile hemodynamics - Penile arterial blood velocity record (cm/s)	0,16 weeks
Secondary	Duplex - Resistance index(RI)	To assess penile hemodynamics - Penile vascular resistance Index	0,16 weeks