Erectile Dysfunction With Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DEVICEShockwave 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): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male 2. Between 30 to 80 years of age (inclusive). 3. Be able to provide written informed consent. 4. 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. 5. Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C \> 7% OR on medical therapy for Diabetes. 6. Be in a stable relationship and have a minimum of 2 sexual attempts per month for at least one month prior to enrollment. 7. 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, penile fracture, Peyronie's Disease, or penile curvature that negatively influences sexual activity. 3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%). 4. Psychogenic ED as determined by study investigator. 5. Patients using Intracavernous Injections (ICI) for management of ED. 6. Patients with generalized polyneuropathy, neurological conditions, or psychiatric disease (such as bipolar disorder or depression). 7. 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. 8. History of consistent treatment failure with Phosphodiesterase 5 (PDE5) inhibitors for therapy of ED. 9. Poorly controlled diabetes as indicated by Hemoglobin a1c \> 7.5%. 10. Use of antiplatelet medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Markers of Vasodilation | Baseline, Month 3, Month 6 | 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. |
| Endothelial Function Markers | Baseline, Month 3, Month 6 | 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. |
| Markers of Neo-angiogenesis | Baseline to Month 3, Baseline to Month 6 | 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. |
| Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs) | Baseline, Month 3, Month 6 | Endothelial Progenitor Cell (EPC) Colony Forming Units (CFUs) as measured from peripheral blood samples in units of average cells per well. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EDITS Questionnaire Scores | Month 3 and Month 6 | 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. |
| Incidence of Serious Adverse Events (SAEs) | Baseline, up to 6 months | Incidence of Serious Adverse Events (SAEs), as assessed by study physician. |
| Penile Blood Flow | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: Baseline, Month 3, Month 6
Population: Baseline blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up.
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.
Time frame: Baseline, Month 3, Month 6
Population: Baseline blood samples unusable due to low cell recovery. Follow up data was not collected due to lost to follow up.
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.
Time frame: Baseline to Month 3, Baseline to Month 6
Population: Baseline blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up.
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.
Time frame: Baseline, Month 3, Month 6
Population: Baseline blood samples unusable due to hemolysis and low cell recovery. Follow up data was not collected due to lost to follow up.
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.
Time frame: Month 3 and Month 6
Population: Data was not collected due to lost to follow up
Secondary
Incidence of Serious Adverse Events (SAEs)
Incidence of Serious Adverse Events (SAEs), as assessed by study physician.
Time frame: Baseline, up to 6 months
Population: Both subjects were considered lost to follow up after completing baseline and Day 0 (treatment visit #1).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Incidence of Serious Adverse Events (SAEs) | 0 events |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Penile Blood Flow | Right Peak Systolic Velocity (PSV) | 39.1 cm/sec |
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Penile Blood Flow | Right End Diastolic Velocity (EDV) | 0.0 cm/sec |
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Penile Blood Flow | Left Peak Systolic Velocity (PSV) | 35.4 cm/sec |
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Penile Blood Flow | Left End Diastolic Velocity (EDV) | 4.2 cm/sec |