Back to resultsPRP for the Treatment of Erectile Dysfunction (ED)
Primary Purpose
Erectile Dysfunction
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- The patient must have given his informed and signed written consent
- The patient has ED for longer than 1 year but less than 5 years.
- The subject has a stable partner for at least 3 months.
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV > 25 cm/sec
Exclusion Criteria:
The patient is participating in another study that may interfere with the results or conclusions of this study
- History of radical prostatectomy or pelvic cancer surgery
- Prior history of pelvic malignancies
- Prior pelvic radiation therapy
- Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
- Psychiatric disease which effects erectile function
- The patient is taking blood thinners
- History of Diabetes Mellitus
- History of Coronary Artery Disease
- Evidence Based Criteria: Doppler Clinical Exam ( PSV < 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies)
- Biochemical evidence of Hypogonadism (total Testosterone < 300 ng/dL)
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Platelet Rich Plasma Treatment
Arm Description
Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections.
Outcomes
Primary Outcome Measures
Treatment-related adverse events
Number of participants to experience treatment-related adverse events defined as reaction in the skin (e.g., swelling, erythema, and warmth), injection site discomfort, penile pain, change in penile appearance, novel sexual concerns and any systemic reactions seen by the investigators, or concerns expressed by patients.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04350125
Brief Title
PRP for the Treatment of Erectile Dysfunction (ED)
Official Title
A Pilot Study Evaluating the Use of Autologous Platelet-rich Plasma (PRP) for the Treatment of Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).
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 1
Interventional Study Model
Sequential Assignment
Model Description
Subjects treated in this study will be divided into 3 cohorts of 5. After the first cohort of 5 subjects have been treated and evaluated for safety, the second cohort of 5 subjects will proceed with treatment followed by review of events for safety. If determined safe to proceed the third cohort of 5 subjects will proceed with treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Plasma Treatment
Arm Type
Experimental
Arm Description
Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections.
Intervention Type
Biological
Intervention Name(s)
Autologous Platelet Rich Plasma
Intervention Description
One 4-5mL platelet rich plasma injection administered to each side of the intracavernosal space on the right and left side of the corpus cavernosum at the base of the penis, every two weeks for 6 weeks.
Primary Outcome Measure Information:
Title
Treatment-related adverse events
Description
Number of participants to experience treatment-related adverse events defined as reaction in the skin (e.g., swelling, erythema, and warmth), injection site discomfort, penile pain, change in penile appearance, novel sexual concerns and any systemic reactions seen by the investigators, or concerns expressed by patients.
Time Frame
35 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must have given his informed and signed written consent
The patient has ED for longer than 1 year but less than 5 years.
The subject has a stable partner for at least 3 months.
The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV > 25 cm/sec
Exclusion Criteria:
The patient is participating in another study that may interfere with the results or conclusions of this study
History of radical prostatectomy or pelvic cancer surgery
Prior history of pelvic malignancies
Prior pelvic radiation therapy
Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
Psychiatric disease which effects erectile function
The patient is taking blood thinners
History of Diabetes Mellitus
History of Coronary Artery Disease
Evidence Based Criteria: Doppler Clinical Exam ( PSV < 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies)
Biochemical evidence of Hypogonadism (total Testosterone < 300 ng/dL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Broderick, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Tamayo Perez
Phone
904-953-8257
Email
TamayoPerez.Michel@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
PRP for the Treatment of Erectile Dysfunction (ED)
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