Erectile Dysfunction
Conditions
Keywords
ED
Brief summary
The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)
Interventions
Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum.
OTHERSaline solution
Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Be Male 2. Be 30 to 75 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 11-25 at screening (even if taking a single PDE5). 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 Intra Cavernous 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 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 Inhibitor or psychotropic medications. 12. Hemoglobin a1c \>9%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving MCID in IIEF-EF. | 1 month, 3 month, 6 month | Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. 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. This outcome is reported as the number of participants who achieve MCID in each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IIEF-EF Scores | Baseline up to Month 1, Month 3, and Month 6 | IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function. |
| Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV) | Baseline to Month 6 | Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound. |
| Number of Adverse Events | 24 weeks | Incidence of adverse events were reported as all urological and/or reproductive system AEs and all AEs with severity grade 3 or higher. Adverse Events severity was determined using CTCAE v5 criteria. |
| Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6. | Baseline and Month 6 | Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRP Group Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days
Autologous Platelet Rich Plasma: Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum. | 28 |
| Placebo Group Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
Saline solution: Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum | 33 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Month 1 | Lost to Follow-up | 2 | 3 |
| Month 3 | Lost to Follow-up | 1 | 3 |
| Month 6 | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Placebo Group | Total | PRP Group |
|---|---|---|---|
| Age, Continuous | 46 years | 47 years | 49 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 36 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 25 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 49 Participants | 23 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 33 Participants | 61 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 33 |
| other Total, other adverse events | 1 / 28 | 1 / 33 |
| serious Total, serious adverse events | 0 / 28 | 0 / 33 |
Outcome results
Primary
Number of Participants Achieving MCID in IIEF-EF.
Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. 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. This outcome is reported as the number of participants who achieve MCID in each treatment group.
Time frame: 1 month, 3 month, 6 month
Population: Not all subjects completed all visits due to lost to follow up or did not complete the IIEF questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Group | Number of Participants Achieving MCID in IIEF-EF. | Month 1 | 14 Participants |
| PRP Group | Number of Participants Achieving MCID in IIEF-EF. | Month 3 | 10 Participants |
| PRP Group | Number of Participants Achieving MCID in IIEF-EF. | Month 6 | 12 Participants |
| Placebo Group | Number of Participants Achieving MCID in IIEF-EF. | Month 1 | 15 Participants |
| Placebo Group | Number of Participants Achieving MCID in IIEF-EF. | Month 3 | 13 Participants |
| Placebo Group | Number of Participants Achieving MCID in IIEF-EF. | Month 6 | 10 Participants |
Secondary
Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)
Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound.
Time frame: Baseline to Month 6
Population: Not all subjects completed all visits due to lost to follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PRP Group | Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV) | 0.4 cm/sec |
| Placebo Group | Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV) | 1.5 cm/sec |
Secondary
Change in IIEF-EF Scores
IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.
Time frame: Baseline up to Month 1, Month 3, and Month 6
Population: Not all subjects completed all visits due to lost to follow up or did not complete the IIEF questionnaire.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PRP Group | Change in IIEF-EF Scores | Baseline to Month 1 | 4.5 score on a scale |
| PRP Group | Change in IIEF-EF Scores | Baseline to Month 3 | 1 score on a scale |
| PRP Group | Change in IIEF-EF Scores | Baseline to Month 6 | 3.5 score on a scale |
| Placebo Group | Change in IIEF-EF Scores | Baseline to Month 1 | 2 score on a scale |
| Placebo Group | Change in IIEF-EF Scores | Baseline to Month 3 | 2 score on a scale |
| Placebo Group | Change in IIEF-EF Scores | Baseline to Month 6 | 2 score on a scale |
Secondary
Number of Adverse Events
Incidence of adverse events were reported as all urological and/or reproductive system AEs and all AEs with severity grade 3 or higher. Adverse Events severity was determined using CTCAE v5 criteria.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRP Group | Number of Adverse Events | 1 events |
| Placebo Group | Number of Adverse Events | 1 events |
Secondary
Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6.
Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound.
Time frame: Baseline and Month 6
Population: The number of participants analyzed are different in certain rows due to attrition and lost to follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Group | Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6. | Baseline | 6 Participants |
| PRP Group | Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6. | Month 6 | 9 Participants |
| Placebo Group | Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6. | Baseline | 11 Participants |
| Placebo Group | Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6. | Month 6 | 8 Participants |