Erectile Dysfunction
Conditions
Brief 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
Interventions
DEVICEShock Wave therapy (SWT)
Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
5 mL PRP will be administered via intracavernous injection
OTHERSham SWT
Sham Shockwave Therapy will be administered in the sham arm.
OTHERPlacebo Saline
5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in IIEF-EF Scores | Baseline, Month 3, Month 6 | International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. |
| Percentage of participants achieving MCID in IIEF-EF | Baseline, Month 3, Month 6 | IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. Mild Clinically Important Difference (MCID) is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED. |
| Penile Blood Flow | Baseline, Month 6 | Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography |
| Circulating Angiogenic Factor levels | Baseline, Month 3, Month 6 | Circulating angiogenic factor levels including Vascular Endothelial Growth Factor (VEGF), Stromal Cell Derived Factor-1 (SDF-1 alpha) and Stem cell Factor (SCF), all reported in pg/mL, will be assessed via blood samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors | Baseline, Month 3 | The number of participants reporting a decrease or discontinue in use of PDE5 inhibitors will be reported |
Countries
United States
Outcome results
None listed