Clincosm LogoSign in Get a demo

The Role of Platelet Rich Plasma for Erectile Dysfunction

Sponsor
University of Nebraska (Other)
Overall Status
Recruiting
CT.gov ID
NCT04357353
Collaborator
(none)
179
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Platelet rich plasma
  • Drug: Placebo Sham Injection
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
179 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Role of Platelet Rich Plasma for Erectile Dysfunction
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Placebo

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

Drug: Placebo Sham Injection
sham injection
Experimental: PRP

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

Drug: Platelet rich plasma
PRP will be used in the experimental arm.

Outcome Measures

Primary Outcome Measures

  1. Erectile Function Change [at 1, 3 and 6 months]

    The rate of change in erectile function measured by IIEF

Other Outcome Measures

  1. Side Effects [at 1, 3 and 6 months]

    any side effects noted by men

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • history of mild to moderate erectile dysfunction measured by IIEF
Exclusion Criteria:
  • history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nebraska Medicine Omaha Nebraska United States 68198

Sponsors and Collaborators

  • University of Nebraska

Investigators

  • Principal Investigator: Chris Deibert, MD, MPJH, University of Nebraska

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher Deibert, Assistant Professor Urology, University of Nebraska
ClinicalTrials.gov Identifier:
NCT04357353
Other Study ID Numbers:
  • 156-20-FB
First Posted:
Apr 22, 2020
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Erectile Dysfunction

Study Results

No Results Posted as of Aug 19, 2021