The Role of Platelet Rich Plasma for Erectile Dysfunction

Phase 3

Terminated

• Conditions: Erectile Dysfunction
• Interventions: Other: Placebo Sham Injection; Biological: Platelet rich plasma

• Registration Number: NCT04357353
• Lead Sponsor: University of Nebraska

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-19
• Study First Posted: 2020-04-22
• Study Start: 2021-04-01
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

• history of mild to moderate erectile dysfunction measured by IIEF

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Sham Injection	All arms will have phlebotomy (blood drawn). This group will receive saline injection only.
Platelet rich plasma	Platelet rich plasma	All arms will have phlebotomy (blood drawn). This group will receive PRP injection only.

Primary Outcome Measures

Name	Time	Method
Erectile Function Change	at 1, 3 and 6 months	The rate of change in erectile function measured by IIEF

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States