Clinical Trials

Inclusion Criteria:

• The patient must have given his informed and signed written consent.
• The patient is a male.
• Between 45 and 65 years of age.
• 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).

Eligibility last updated 11/30/22. Questions regarding updates should be directed to the study team contact.