Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction

Study Overview
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Brief Summary
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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

Official Title
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Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Shock Wave therapy (SWT)
* Drug: Platelet Rich Plasma (PRP)
* Other: Sham SWT
* Other: Placebo Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be Male Be 30 to 80 years of age (inclusive). Be able to provide written informed consent. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent. Sexually active in a stable, heterosexual relationship of more than three months duration. IIEF-EF score 12-25 at screening 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. Agree to comply with all study related tests/procedures. Exclusion Criteria: Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting. Previous history of priapism or penile fracture 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%). 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. Psychogenic ED as determined by study investigator. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area. Patients using Intracavernosal Injection (ICI) for management of ED Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease. 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. History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED. 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. Hemoglobin a1c >9%.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SWT plus PRP Group<br>Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5. | Device: Shock Wave therapy (SWT)<br>* Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.<br>Drug: Platelet Rich Plasma (PRP)<br>* 5 mL PRP will be administered via intracavernous injection<br>|
| Placebo Comparator: Sham SWT plus Placebo Saline Group<br>Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5. | Other: Sham SWT<br>* Sham Shockwave Therapy will be administered in the sham arm.<br>Other: Placebo Saline<br>* 5 mL Placebo saline will be administered via intracavernous injection in the sham arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IIEF-EF Scores | 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. | Baseline, Month 3, Month 6 | 
| Percentage of participants achieving MCID in IIEF-EF | 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. | Baseline, Month 3, Month 6 | 
| Penile Blood Flow | 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 | Baseline, Month 6 | 
| Circulating Angiogenic Factor levels | 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 | Baseline, Month 3, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors | The number of participants reporting a decrease or discontinue in use of PDE5 inhibitors will be reported | Baseline, Month 3 |