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Platelet-rich Plasma(PRP) Injection in ED

Primary Purpose

Erectile Dysfunction, PRP

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PRP
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP

Arm Description

PRP injection

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Duplex - Peak systolic velocity(PSV)
To assess penile hemodynamics - Penile arterial blood velocity record (cm/s)
Duplex - Resistance index(RI)
To assess penile hemodynamics - Penile vascular resistance Index

Full Information

First Posted
October 6, 2021
Last Updated
February 14, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05241964
Brief Title
Platelet-rich Plasma(PRP) Injection in ED
Official Title
A Prospective Trial of Autologous Platelet-rich Plasma Injection in Erectile Dysfunction Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
September 22, 2022 (Anticipated)
Study Completion Date
November 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, PRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP
Arm Type
Experimental
Arm Description
PRP injection
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
4~6ml autologous platelet rich plasma injection every 14±2 days for a total of 5 injections.
Primary Outcome Measure Information:
Title
International Index of Erectile Function(IIEF-5)
Description
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 Outcome Measure Information:
Title
Erection Hardness Score(EHS)
Description
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
Time Frame
Change from 0 week at 4,8,12,24,48 weeks
Title
Duplex - Peak systolic velocity(PSV)
Description
To assess penile hemodynamics - Penile arterial blood velocity record (cm/s)
Time Frame
0,16 weeks
Title
Duplex - Resistance index(RI)
Description
To assess penile hemodynamics - Penile vascular resistance Index
Time Frame
0,16 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I-Ni Chiang, MD
Phone
+886919077219
Email
inichiang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Ni Chiang, MD
Organizational Affiliation
Taipei Veteran General hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I-NI CHIANG, MD
Email
inichiang@gmail.com
Phone
+886919077219

12. IPD Sharing Statement

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Platelet-rich Plasma(PRP) Injection in ED

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