Platelet-rich Plasma(PRP) Injection in ED

February 14, 2022 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:
          • Phone Number: +886919077219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PRP
PRP injection
Biological: PRP
4~6ml autologous platelet rich plasma injection every 14±2 days for a total of 5 injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Function(IIEF-5)
Time Frame: 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).
Change from 0 week at 4,8,12,24,48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erection Hardness Score(EHS)
Time Frame: 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
Change from 0 week at 4,8,12,24,48 weeks
Duplex - Peak systolic velocity(PSV)
Time Frame: 0,16 weeks
To assess penile hemodynamics - Penile arterial blood velocity record (cm/s)
0,16 weeks
Duplex - Resistance index(RI)
Time Frame: 0,16 weeks
To assess penile hemodynamics - Penile vascular resistance Index
0,16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: I-Ni Chiang, MD, Taipei Veteran General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2021

Primary Completion (ANTICIPATED)

September 22, 2022

Study Completion (ANTICIPATED)

November 29, 2022

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

February 14, 2022

First Posted (ACTUAL)

February 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202008061RIPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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