Platelet-rich Plasma(PRP) Injection in ED

N/AUnknownNCT05241964

National Taiwan University Hospital30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction PRP

Interventions

PRPBIOLOGICAL

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Change from 0 week at 4,8,12,24,48 weeks

Secondary Outcomes

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 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

Time frame: 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)

Time frame: 0,16 weeks

Duplex - Resistance index(RI)

To assess penile hemodynamics - Penile vascular resistance Index

Time frame: 0,16 weeks

Central Contacts

I-Ni Chiang, MD

CONTACT

+886919077219 inichiang@gmail.com

Data from ClinicalTrials.gov

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