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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Autologous Platelet Rich Plasma

Saline solution

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring ED

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Be Male
Be 30 to 75 years of age (inclusive).
Be able to provide written informed consent.
Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
Sexually active in a stable, heterosexual relationship of more than three months duration.
IIEF-EF score 11-25 at screening (even if taking a single PDE5).
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.
Agree to comply with all study related tests/procedures.

Exclusion Criteria:

Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
Previous history of priapism or penile fracture
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%).
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.
Psychogenic ED as determined by study investigator.
Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
Patients using Intra Cavernous Injection (ICI)for management of ED
Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
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.
History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
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.
Hemoglobin a1c >9%.

Sites / Locations

University of Miami Miller School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRP group

Placebo group

Arm Description

Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days

Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.

Outcomes

Primary Outcome Measures

Percentage of participants achieving MCID in IIEF-EF

Treatment efficacy of PRP will be assessed via the percentage of participants achieving mild clinically important difference (MCID) in their IIEF-EF scores from baseline to 4 weeks after final treatment. International Index of Erectile Function - Erectile Function Subdomain Score (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. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.

Secondary Outcome Measures

Percentage of participants achieving MCID in IIEF-EF

Treatment efficacy of PRP will be assessed via the percentage of participants achieving MCID in their IIEF-EF scores from baseline to 2 and 24 weeks after final treatment. 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. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.

Change in IIEF-EF Scores

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.

Change in doppler ultrasound parameters

Change in Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) assessed in cm/sec via ultrasound.

Incidence of adverse events

Safety will be evaluated via the incidence of adverse events as assessed by treating physician

Full Information

NCT ID

NCT04396795

First Posted

April 3, 2020

Last Updated

April 20, 2023

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT04396795

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 21, 2020 (Actual)

Primary Completion Date

January 23, 2023 (Actual)

Study Completion Date

April 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

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

Erectile Dysfunction

Keywords

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRP group

Arm Type

Experimental

Arm Description

Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.

Intervention Type

Drug

Intervention Name(s)

Autologous Platelet Rich Plasma

Other Intervention Name(s)

PRP

Intervention Description

Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.

Intervention Type

Other

Intervention Name(s)

Saline solution

Intervention Description

Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL s each injected to the right and left corpus cavernosum

Primary Outcome Measure Information:

Title

Percentage of participants achieving MCID in IIEF-EF

Description

Time Frame

9 weeks

Secondary Outcome Measure Information:

Title

Percentage of participants achieving MCID in IIEF-EF

Description

Time Frame

24 weeks

Title

Change in IIEF-EF Scores

Description

Time Frame

Baseline up to Week 9, Baseline up to Week 17, Baseline up to Week 29

Title

Change in doppler ultrasound parameters

Description

Change in Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) assessed in cm/sec via ultrasound.

Time Frame

Baseline, Up to 29 weeks

Title

Incidence of adverse events

Description

Safety will be evaluated via the incidence of adverse events as assessed by treating physician

Time Frame

24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be Male Be 30 to 75 years of age (inclusive). Be able to provide written informed consent. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent. Sexually active in a stable, heterosexual relationship of more than three months duration. IIEF-EF score 11-25 at screening (even if taking a single PDE5). 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. Agree to comply with all study related tests/procedures. Exclusion Criteria: Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting. Previous history of priapism or penile fracture 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%). 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. Psychogenic ED as determined by study investigator. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area. Patients using Intra Cavernous Injection (ICI)for management of ED Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease. 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. History of consistent treatment failure with PDE5 inhibitors for therapy of ED. 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. Hemoglobin a1c >9%.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ranjith Ramasamy, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami Miller School of Medicine

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24080861

Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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

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