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
University of Miami
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 |
|---|---|---|
| Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period. | Baseline, Month 3 | A treatment emergent serious adverse event (TE-SAE) is defined as any serious adverse event for which there is a reasonable possibility that the investigational product caused the adverse event. For the purposes of safety reporting, "a reasonable possibility" means there is evidence to suggest a causal relationship between the study product/procedures and the adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IIEF-EF Scores | Baseline, 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. Score ranges are commonly interpreted as: Severe ED: 0-10, Moderate ED: 11-16, Mild ED: 17-21, No ED / Normal erectile function: 22-25. Change from Baseline at Month 6 reported. |
| Percentage of Participants Achieving MCID in IIEF-EF at Any Post-treatment Timepoint in Each Group. | Baseline, Month 3, or 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. Participants are counted as achieving MCID if they meet the criteria at either the Month 3 or Month 6 assessment (or both). |
| Percentage of Participants Who Either Decrease or Discontinue Use of PDE5i After Three Months Post-therapy Compared to Control Group | Baseline, Month 3 | The percentage of participants who report either a reduction in frequency of PDE5 inhibitor use or complete discontinuation of PDE5 inhibitors at 3 months following completion of the intervention, compared to the control group. PDE5 inhibitor use will be assessed through participant self-report. A decrease in use is defined as a reduction in dose or frequency. Discontinuation is defined as complete cessation of PDE5 inhibitor use. The percentage will be calculated as the number of participants meeting either criterion divided by the total number of participants in each group. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREmad Ibrahim, MD
University of Miami
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 2 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 29 |
| other Total, other adverse events | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
None listed