Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.

December 15, 2023 updated by: Ranjith Ramasamy, MD, University of Miami

A Randomized Control, Double-Blind, Placebo Controlled, Multicenter Clinical Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma Injection Treatment for Erectile Dysfunction.

The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Be Male
  2. Be 30 to 75 years of age (inclusive).
  3. Be able to provide written informed consent.
  4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
  5. Sexually active in a stable, heterosexual relationship of more than three months duration.
  6. IIEF-EF score 11-25 at screening (even if taking a single PDE5).
  7. Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
  8. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

  1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
  2. Previous history of priapism or penile fracture
  3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
  4. Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
  5. Psychogenic ED as determined by study investigator.
  6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
  7. Patients using Intra Cavernous Injection (ICI)for management of ED
  8. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
  9. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
  10. History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
  11. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitor or psychotropic medications.
  12. Hemoglobin a1c >9%.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP group
Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days
Drug: Autologous Platelet Rich Plasma
Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum.
Other Names:
  • PRP
Placebo Comparator: Placebo group
Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
Other: Saline solution
Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving MCID in IIEF-EF.
Time Frame: 1 month, 3 month, 6 month
Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. This outcome is reported as the number of participants who achieve MCID in each treatment group.
1 month, 3 month, 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IIEF-EF Scores
Time Frame: Baseline up to Month 1, Month 3, and Month 6
IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.
Baseline up to Month 1, Month 3, and Month 6
Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)
Time Frame: Baseline to Month 6
Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound.
Baseline to Month 6
Number of Adverse Events
Time Frame: 24 weeks
Incidence of adverse events were reported as all urological and/or reproductive system AEs and all AEs with severity grade 3 or higher. Adverse Events severity was determined using CTCAE v5 criteria.
24 weeks
Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6.
Time Frame: Baseline and Month 6
Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound.
Baseline and Month 6

Collaborators and Investigators

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

Sponsor

University of Miami

Investigators

  • Principal Investigator: Ranjith Ramasamy, MD, University of Miami

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)

May 21, 2020

Primary Completion (Actual)

January 23, 2023

Study Completion (Actual)

April 18, 2023

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200373

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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