Trial Outcomes & Findings for Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction (NCT NCT05048667)
NCT ID: NCT05048667
Last Updated: 2026-05-22
Results Overview
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.
COMPLETED
PHASE1
59 participants
Baseline, Month 3
2026-05-22
Participant Flow
Participant milestones
| Measure |
SWT + PRP Group
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Shock Wave therapy (SWT): Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection
|
Sham SWT + Placebo Saline Group
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Sham SWT: Sham Shockwave Therapy will be administered in the sham arm.
Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
| Measure |
SWT + PRP Group
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Shock Wave therapy (SWT): Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection
|
Sham SWT + Placebo Saline Group
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Sham SWT: Sham Shockwave Therapy will be administered in the sham arm.
Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
11
|
Baseline Characteristics
Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
SWT + PRP Group
n=30 Participants
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Shock Wave therapy (SWT): Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection
|
Sham SWT + Placebo Saline Group
n=29 Participants
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Sham SWT: Sham Shockwave Therapy will be administered in the sham arm.
Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 9.3 • n=2 Participants
|
53 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
53 years
STANDARD_DEVIATION 10.2 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=2 Participants
|
29 Participants
n=4 Participants
|
59 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=2 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=2 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=2 Participants
|
24 Participants
n=4 Participants
|
47 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3A 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.
Outcome measures
| Measure |
SWT + PRP Group
n=30 Participants
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Shock Wave therapy (SWT): Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection
|
Sham SWT + Placebo Saline Group
n=29 Participants
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Sham SWT: Sham Shockwave Therapy will be administered in the sham arm.
Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Number of participants analyzed is less than the total number of subjects enrolled due to attrition, lost to follow up, and missing data.
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.
Outcome measures
| Measure |
SWT + PRP Group
n=19 Participants
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Shock Wave therapy (SWT): Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection
|
Sham SWT + Placebo Saline Group
n=20 Participants
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Sham SWT: Sham Shockwave Therapy will be administered in the sham arm.
Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
|
|---|---|---|
|
Change in IIEF-EF Scores
|
2 score on a scale
Interval -2.0 to 7.0
|
2.5 score on a scale
Interval -3.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline, Month 3, or Month 6Population: Number of participants analyzed is less than the total number of subjects enrolled due to attrition, lost to follow up, and missing data.
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).
Outcome measures
| Measure |
SWT + PRP Group
n=19 Participants
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Shock Wave therapy (SWT): Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection
|
Sham SWT + Placebo Saline Group
n=20 Participants
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Sham SWT: Sham Shockwave Therapy will be administered in the sham arm.
Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
|
|---|---|---|
|
Percentage of Participants Achieving MCID in IIEF-EF at Any Post-treatment Timepoint in Each Group.
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: This outcome measure only applies to subjects who were taking PDE5i at baseline. those who were not taking medicaitons in theis class were excluded from the analysis. In addition, participants who withdrew consent or were lost to follow up before the month 3 visit were also excluded from the analysis due to missing data.
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.
Outcome measures
| Measure |
SWT + PRP Group
n=11 Participants
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Shock Wave therapy (SWT): Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.
Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intracavernous injection
|
Sham SWT + Placebo Saline Group
n=14 Participants
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Sham SWT: Sham Shockwave Therapy will be administered in the sham arm.
Placebo Saline: 5 mL Placebo saline will be administered via intracavernous injection in the sham arm.
|
|---|---|---|
|
Percentage of Participants Who Either Decrease or Discontinue Use of PDE5i After Three Months Post-therapy Compared to Control Group
Decreased or Discontinued
|
1 Participants
|
0 Participants
|
|
Percentage of Participants Who Either Decrease or Discontinue Use of PDE5i After Three Months Post-therapy Compared to Control Group
No Change
|
10 Participants
|
14 Participants
|
Adverse Events
SWT + PRP Group
Sham SWT + Placebo Saline Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emad Ibrahim
University of Miami, Miller School of Medicine - Desai Sethi Urology Institute (DSUI)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place