The Role of Platelet Rich Plasma for Erectile Dysfunction

University of Nebraska

Status and phase: Terminated; Phase 3

Conditions: Erectile Dysfunction

Treatments: Other: Placebo Sham Injection; Biological: Platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04357353

0156-20-FB

Details and patient eligibility

About

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.

Full description

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

Enrollment: 13 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• history of mild to moderate erectile dysfunction measured by IIEF

Exclusion criteria

• history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

Placebo

Sham Comparator group

Description:

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

Treatment:

Other: Placebo Sham Injection

Platelet rich plasma

Experimental group

Description:

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

Treatment:

Biological: Platelet rich plasma