The Role of Platelet Rich Plasma for Erectile Dysfunction

NCT ID: NCT04357353

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-11-02

Brief Summary

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Purpose of Study: This randomized controlled trial investigates the role that platelet rich plasma injections into the penis may play to improve erectile function in men with erectile dysfunction.

Detailed Description

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Eligibility: Men with erectile dysfunction. Ages 50-80. International Index of Erectile Function score of mild (17-21/25) or moderate (8-16/25).

Intervention and Evaluation:Men who consent to join the trial will be randomized to receive either a single injection PRP or saline to the penis. All patients will have blood drawn in clinic the day of injection. Those randomized to PRP arm will have their own blood prepared and separated into the PRP. This solution of their own blood will be injected back into the penis.

Follow Up: Men will be evaluated at 1 , 3, and 6 months after the injections and then asked to complete the IIEF by phone or by electronic means

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

All arms will have phlebotomy (blood drawn). This group will receive saline injection only.

Group Type SHAM_COMPARATOR

Placebo Sham Injection

Intervention Type OTHER

sham injection

Platelet rich plasma

All arms will have phlebotomy (blood drawn). This group will receive PRP injection only.

Group Type EXPERIMENTAL

Platelet rich plasma

Intervention Type BIOLOGICAL

PRP will be used in the experimental arm.

Interventions

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Platelet rich plasma

PRP will be used in the experimental arm.

Intervention Type BIOLOGICAL

Placebo Sham Injection

sham injection

Intervention Type OTHER

Other Intervention Names

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blood plasma Placebo

Eligibility Criteria

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Inclusion Criteria

* history of mild to moderate erectile dysfunction measured by IIEF

Exclusion Criteria

* history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Deibert, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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0156-20-FB

Identifier Type: -

Identifier Source: org_study_id

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