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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Experimental | Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Therapy (SWT) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, Month 3, Month 6 |
| 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, Month 3, Month 6 |
| 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 |
| Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs) | Endothelial Progenitor Cell (EPC) Colony Forming Units (CFUs) as measured from peripheral blood samples in units of average cells per well. | Baseline, Month 3, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| EDITS Questionnaire Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Masterson, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami, School of Medicine - Desai Sethi Urology Institute | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Shockwave Therapy (SWT): 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. Autologous Platelet-Rich Plasma (PRP): Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2023 |
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| Autologous Platelet-Rich Plasma (PRP) | Drug | Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval. |
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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.
| Month 3 and Month 6 |
| Incidence of Serious Adverse Events (SAEs) | Incidence of Serious Adverse Events (SAEs), as assessed by study physician. | Baseline, up to 6 months |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Shockwave Therapy (SWT): 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. Autologous Platelet-Rich Plasma (PRP): Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up. | Posted | Baseline, Month 3, Month 6 |
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| Primary | 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 blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up. | Posted | Baseline, Month 3, Month 6 |
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| Primary | 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 blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up. | Posted | Baseline to Month 3, Baseline to Month 6 |
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| Primary | Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs) | Endothelial Progenitor Cell (EPC) Colony Forming Units (CFUs) as measured from peripheral blood samples in units of average cells per well. | Baseline blood samples unusable due to low cell recovery. Follow up data was not collected due to lost to follow up. | Posted | Baseline, Month 3, Month 6 |
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| Secondary | 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. | First subject completed baseline ultrasound. Second subject did not complete baseline ultrasound. Both subjects were lost to follow up before completing the month 6 visit. The measured value for Right EDV is "0.0", not a missing value. | Posted | Mean | Standard Deviation | cm/sec | Baseline |
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| Secondary | 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. | Data was not collected due to lost to follow up | Posted | Month 3 and Month 6 |
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| Secondary | Incidence of Serious Adverse Events (SAEs) | Incidence of Serious Adverse Events (SAEs), as assessed by study physician. | Both subjects were considered "lost to follow up" after completing baseline and Day 0 (treatment visit #1). | Posted | Number | events | Baseline, up to 6 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Shockwave Therapy (SWT): 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. Autologous Platelet-Rich Plasma (PRP): Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval. | 0 | 2 | 0 | 2 | 0 | 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas A Masterson, III | University of Miami, Miller School of Medicine | (305) 243 - 6260 | TMasterson@med.miami.edu |
| Nov 21, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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