PRP for the Treatment of Erectile Dysfunction (ED)

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction

Treatments: Biological: Autologous Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04350125

18-010364

Details and patient eligibility

About

Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).

Enrollment: 4 patients

Sex: Male

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Platelet Rich Plasma Treatment

Experimental group

Description:

Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections.

Treatment:

Biological: Autologous Platelet Rich Plasma