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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05241964
Other study ID # 202008061RIPC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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