Trial Outcomes & Findings for Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction. (NCT NCT04396795)
NCT ID: NCT04396795
Last Updated: 2024-01-09
Results Overview
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.
COMPLETED
PHASE2
61 participants
1 month, 3 month, 6 month
2024-01-09
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Baseline
STARTED
|
28
|
33
|
|
Baseline
COMPLETED
|
28
|
33
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Month 1
STARTED
|
28
|
33
|
|
Month 1
COMPLETED
|
26
|
30
|
|
Month 1
NOT COMPLETED
|
2
|
3
|
|
Month 3
STARTED
|
26
|
30
|
|
Month 3
COMPLETED
|
25
|
27
|
|
Month 3
NOT COMPLETED
|
1
|
3
|
|
Month 6
STARTED
|
25
|
27
|
|
Month 6
COMPLETED
|
22
|
24
|
|
Month 6
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
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
Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.
Baseline characteristics by cohort
| Measure |
PRP Group
n=28 Participants
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.
|
Placebo Group
n=33 Participants
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
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
46 years
n=7 Participants
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month, 3 month, 6 monthPopulation: Not all subjects completed all visits due to lost to follow up or did not complete the IIEF questionnaire.
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.
Outcome measures
| Measure |
PRP Group
n=24 Participants
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.
|
Placebo Group
n=28 Participants
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
|
|---|---|---|
|
Number of Participants Achieving MCID in IIEF-EF.
Month 1
|
14 Participants
|
15 Participants
|
|
Number of Participants Achieving MCID in IIEF-EF.
Month 3
|
10 Participants
|
13 Participants
|
|
Number of Participants Achieving MCID in IIEF-EF.
Month 6
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 1, Month 3, and Month 6Population: Not all subjects completed all visits due to lost to follow up or did not complete the IIEF questionnaire.
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.
Outcome measures
| Measure |
PRP Group
n=24 Participants
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.
|
Placebo Group
n=28 Participants
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
|
|---|---|---|
|
Change in IIEF-EF Scores
Baseline to Month 1
|
4.5 score on a scale
Interval 0.0 to 8.5
|
2 score on a scale
Interval -0.5 to 8.0
|
|
Change in IIEF-EF Scores
Baseline to Month 3
|
1 score on a scale
Interval -3.0 to 7.5
|
2 score on a scale
Interval -1.0 to 6.0
|
|
Change in IIEF-EF Scores
Baseline to Month 6
|
3.5 score on a scale
Interval 0.0 to 9.5
|
2 score on a scale
Interval -2.5 to 7.0
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Not all subjects completed all visits due to lost to follow up.
Change in Peak Systolic Velocity (PSV) assessed in cm/sec via ultrasound.
Outcome measures
| Measure |
PRP Group
n=22 Participants
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.
|
Placebo Group
n=24 Participants
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
|
|---|---|---|
|
Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)
|
0.4 cm/sec
Interval -9.6 to 15.3
|
1.5 cm/sec
Interval -3.4 to 14.8
|
SECONDARY outcome
Timeframe: 24 weeksIncidence 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.
Outcome measures
| Measure |
PRP Group
n=28 Participants
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.
|
Placebo Group
n=33 Participants
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
|
|---|---|---|
|
Number of Adverse Events
|
1 events
|
1 events
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: The number of participants analyzed are different in certain rows due to attrition and lost to follow up.
Number of participants who had an End Diastolic Velocity (EDV) value of greater than 0, as assessed by penile doppler ultrasound.
Outcome measures
| Measure |
PRP Group
n=28 Participants
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.
|
Placebo Group
n=33 Participants
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
|
|---|---|---|
|
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
|
11 Participants
|
|
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
|
8 Participants
|
Adverse Events
PRP Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRP Group
n=28 participants at risk
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.
|
Placebo Group
n=33 participants at risk
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
|
|---|---|---|
|
Vascular disorders
Hematoma
|
0.00%
0/28 • 6 months
|
3.0%
1/33 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
3.6%
1/28 • Number of events 1 • 6 months
|
0.00%
0/33 • 6 months
|
Additional Information
Dr Ranjith Ramasamy
University of Miami, Miller School of Medicine - Desai Sethi Urology Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place