Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this research study is to evaluate whether the combination of Shock Wave
Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of
microvascular Erectile Dysfunction (ED) and enhance erectile function by improving
vasodilation, and endothelial function
Phase
Phase 1
Funding Agency/Sponsor
Other
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
1. Be Male
2. Be 30 to 80 years of age (inclusive).
3. Be able to provide written informed consent.
4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
5. Sexually active in a stable, heterosexual relationship of more than three months
duration.
6. IIEF-EF score 12-25 at screening
7. Agree to attempt sexual intercourse at least 4 times per month for the duration of the
study without being under the influence of alcohol or recreational drugs.
8. Agree to comply with all study related tests/procedures.
Exclusion Criteria:
1. Previous penile surgery of any kind (except circumcision and condyloma removal), such
as penile lengthening, penile cancer surgery, penile plication, grafting.
2. Previous history of priapism or penile fracture
3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL
(±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
4. Current or previous hormone usage, other than prescribed testosterone, clomiphene or
thyroid medication. (Subjects with prior or current use of hormonal treatment for
prostate cancer are also excluded.
5. Psychogenic ED as determined by study investigator.
6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual
activity) or neurological abnormalities in the treatment area.
7. Patients using Intracavernosal Injection (ICI) for management of ED
8. Patients with generalized polyneuropathy, or neurological conditions irrespective of
cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
9. Have a serious comorbid illness/condition/behavior that, in the opinion of the
investigator, may compromise the safety or compliance of the subject or preclude
successful completion of the study.
10. History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5)
inhibitors for therapy of ED.
11. Any history of significant psychiatric disease, such as bipolar disorder or psychosis,
greater than one lifetime episode of major depression, current depression of moderate
or greater severity. Patients who are currently using Selective Serotonin Reuptake
Inhibitors (SSRI) or psychotropic medications.
12. Hemoglobin a1c >9%.