Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)

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 Shockwave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function in diabetics patients.

Official Title
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Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)

Conditions
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Erectile Dysfunction With Diabetes Mellitus

Intervention / Treatment
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* Device: Shockwave Therapy (SWT)
* Drug: Autologous Platelet-Rich Plasma (PRP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Between 30 to 80 years of age (inclusive). Be able to provide written informed consent. Have a diagnosis of Mild to Moderate ED (12-21) or Mild ED (22-25) based on International Index of Erectile Dysfunction - Erectile Function (IIEF-EF) questionnaire score. Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C > 7% OR on medical therapy for Diabetes. Be in a stable relationship and have a minimum of 2 sexual attempts per month for at least one month prior to enrollment. 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, penile fracture, Peyronie's Disease, or penile curvature that negatively influences sexual activity. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%). Psychogenic ED as determined by study investigator. Patients using Intracavernous Injections (ICI) for management of ED. Patients with generalized polyneuropathy, neurological conditions, or psychiatric disease (such as bipolar disorder or depression). Have a serious comorbid illness or condition 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 5 (PDE5) inhibitors for therapy of ED. Poorly controlled diabetes as indicated by Hemoglobin a1c > 7.5%. Use of antiplatelet medications

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group<br>Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. | Device: Shockwave Therapy (SWT)<br>* Shockwave Therapy (SWT): 720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions.<br>Drug: Autologous Platelet-Rich Plasma (PRP)<br>* Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in markers of vasodilation | Markers of vasodilation including Endothelial Nitric Oxide Synthase (eNOS) and Neuronal Nitric Oxide Synthase (nNOS) will be measured from serum blood samples in units of ug/mL. | Baseline to Month 3, Baseline to Month 6 | 
| Changes in endothelial function markers | Markers of endothelial function will include Vascular Endothelial Growth Factor (VEGF), Stromal cell-derived factor 1 (SDF-1α), and Stem Cell Factor (SCF). All measured from serum blood samples in units of pg/mL. | Baseline to Month 3, Baseline to Month 6 | 
| Changes in markers of neo-angiogenesis | Markers of neo-angiogenesis reported as the percentage of Cluster of Differentiation 31 positive cells (CD31+), as measured from serum blood samples and expressed as a percentage. | Baseline to Month 3, Baseline to Month 6 | 
| Changes in Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs) | Endothelial Progenitor Cell - Colony Forming Units (EPCs-CFUs) as measured from peripheral blood samples in units of average cells per well. | Baseline to Month 3, Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Penile Blood Flow | Penile Blood Flow will be reported as change in Peak Systolic Velocity (PSV) and change in End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography. | Baseline to Month 6 | 
| EDITS questionnaire scores | Treatment satisfaction is assessed by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. EDITS questionnaire is an 11-item tool addressing participant satisfaction with ED therapy. Each item is a 5-point Likert-type scale from 0 no satisfaction or dissatisfaction to 4 high satisfaction. Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction. | At Month 3 and At Month 6 | 
| Incidence of Serious Adverse Events (SAEs) | As assessed by treating physician | Up to Month 6 |