Combined Treatment of Platelet-rich Plasma (PRP) and Low-intensity Extracorporeal Shockwave Therapy (Li-ESWT) on Erectile Dysfunction (ED)

October 4, 2022 updated by: Ming-Che Liu, MD, Taipei Medical University Hospital

A Clinical Study of the Combined Treatment of Platelet-rich Plasma and Low-intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction

The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

According to statistics from the Taiwan Society of Andrology, 18 to 25 years old male population in Taiwan having erectile dysfunction (ED) trouble is as high as 5 to 10 percent. At the same time, statistics from the Taiwan Sexual Dysfunction Counseling Training Committee show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction. Erectile dysfunction is the most common sexual dysfunction in men and is believed to be related to nerve or blood vessel damage, and often significantly affects the patients' quality of life.

PRP is the abbreviation of "platelet-rich plasma". It can release growth factors and cytokines in the body to further promote tissue repair. The results of pre-clinical and clinical trials show that PRP can promote the repair of cavernous tissue, protect erection function of nerve, and stimulate the regeneration of nerve.

Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a non-invasive treatment. Under this treatment, it will help body producing angiogenesis-related proteins, stimulating the formation of small blood vessels, generating new blood vessels at the site to be treated, and increasing the perfusion flow of local tissues. Li-ESWT has been clinically shown to have a significant effect on erectile dysfunction.

The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University Hospital
        • Principal Investigator:
          • Ming-Che Liu, MD

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Impotence for more than three months
  • International index of erectile function, (IIEF) less than 21( including 21)
  • Erectile hardness score, (EHS) less than 3( including 3)
  • Age over 30 years old

Exclusion Criteria:

  • Hypogonadism
  • Bleeding tendency
  • Could not cooperate with the treatment
  • AIDS, syphilis and condyloma victim
  • Received radical prostatectomy
  • Prostate cancer or pelvis malignant tumor victim
  • Gonad dysfunction
  • Penis deformities
  • Penile prosthesis implantation
  • Psychiatric disease victim
  • Neural disease ( multiple myeloma , brain atrophy, etc)
  • Pacemaker implantation
  • Not suitable join this trial judged by Investigator
  • Alcohol or drug abuse

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP and Li-ESWT treatment
Participants diagnosed with erectile dysfunction will receive the combined treatment of platelet-rich plasma and low-intensity extracorporeal shockwave therapy.
Combination product: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy

The patient who encounters sexual dysfunction and visits our Outpatient Department (OPD) could enter this trial if he meets the inclusion criteria and exclusion criteria.

  1. To fill the questionnaires of International index of erectile function (IIEF) and erectile hardness score (EHS) before starting treatment.
  2. Li-ESWT treatment weekly for three weeks and PRP injection at the same day after the last Li-ESWT treatment.
  3. Coming back at the fourth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
  4. Li-ESWT treatment weekly for three weeks starts on fifth week and PRP injection at the same day after the last Li-ESWT treatment.
  5. Coming back at the eighth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
  6. Coming back at the twelfth week and check is there any side effect and fill the questionnaires of IIEF and EHS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Erectile Function
Time Frame: Baseline, the 4th week, 8th week, and 12th weeks
Using the International Index of Erectile Function (IIEF) questionnaire.
Baseline, the 4th week, 8th week, and 12th weeks
The Change in Erectile Function
Time Frame: Baseline, the 4th week, 8th week, and 12th weeks
Using the Erectile Hardness Scale (EHS) questionnaire to evaluate the efficacy of combined treatment of PRP and Li-ESWT
Baseline, the 4th week, 8th week, and 12th weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidents of Side Effects
Time Frame: the 4th week, 8th week, and 12th weeks
To observe whether there are side effects
the 4th week, 8th week, and 12th weeks

Collaborators and Investigators

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

Sponsor

Taipei Medical University Hospital

Investigators

  • Principal Investigator: Ming-Che Liu, MD, Taipei Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 28, 2020

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201907013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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