Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
4 participants
INTERVENTIONAL
2022-03-04
2023-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Platelet Rich Plasma Treatment
Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections.
Autologous Platelet Rich Plasma
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.
Interventions
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Autologous Platelet Rich Plasma
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
45 Years
65 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Gregory A. Broderick
Principal Investigator
Principal Investigators
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Gregory Broderick, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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18-010364
Identifier Type: -
Identifier Source: org_study_id
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