Back to resultsThe Role of Platelet Rich Plasma for Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Platelet rich plasma
Placebo Sham Injection
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- history of mild to moderate erectile dysfunction measured by IIEF
Exclusion Criteria:
- history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)
Sites / Locations
- Unversity of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Placebo
Platelet rich plasma
Arm Description
All arms will have phlebotomy (blood drawn). This group will receive saline injection only.
All arms will have phlebotomy (blood drawn). This group will receive PRP injection only.
Outcomes
Primary Outcome Measures
Erectile Function Change
The rate of change in erectile function measured by IIEF
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04357353
Brief Title
The Role of Platelet Rich Plasma for Erectile Dysfunction
Official Title
The Role of Platelet Rich Plasma for Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
All arms will have phlebotomy (blood drawn). This group will receive saline injection only.
Arm Title
Platelet rich plasma
Arm Type
Experimental
Arm Description
All arms will have phlebotomy (blood drawn). This group will receive PRP injection only.
Intervention Type
Biological
Intervention Name(s)
Platelet rich plasma
Other Intervention Name(s)
blood plasma
Intervention Description
PRP will be used in the experimental arm.
Intervention Type
Other
Intervention Name(s)
Placebo Sham Injection
Other Intervention Name(s)
Placebo
Intervention Description
sham injection
Primary Outcome Measure Information:
Title
Erectile Function Change
Description
The rate of change in erectile function measured by IIEF
Time Frame
at 1, 3 and 6 months
Other Pre-specified Outcome Measures:
Title
Side Effects
Description
any side effects noted by men
Time Frame
at 1, 3 and 6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only men suffer from erectile dysfunction
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
history of mild to moderate erectile dysfunction measured by IIEF
Exclusion Criteria:
history or prostate cancer treatment (prostatectomy, radiation, brachytherapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Deibert, MD, MPH
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Platelet Rich Plasma for Erectile Dysfunction
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