Trial Outcomes & Findings for Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up (NCT NCT03670628)
NCT ID: NCT03670628
Last Updated: 2023-07-10
Results Overview
The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Results posted on
2023-07-10
Participant Flow
Unable to complete target enrollment due to COVID-19 pandemic restrictions.
Participant milestones
| Measure |
720 Shockwave Therapy Group
Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
Sham Shockwave Therapy
Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).
Sham shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
|---|---|---|
|
Baseline Visit
STARTED
|
13
|
10
|
|
Baseline Visit
COMPLETED
|
13
|
10
|
|
Baseline Visit
NOT COMPLETED
|
0
|
0
|
|
Weekly Therapy Sessions
STARTED
|
13
|
10
|
|
Weekly Therapy Sessions
COMPLETED
|
5
|
7
|
|
Weekly Therapy Sessions
NOT COMPLETED
|
8
|
3
|
|
Month 1 Visit
STARTED
|
5
|
7
|
|
Month 1 Visit
COMPLETED
|
5
|
7
|
|
Month 1 Visit
NOT COMPLETED
|
0
|
0
|
|
Waiting Period
STARTED
|
5
|
7
|
|
Waiting Period
COMPLETED
|
1
|
1
|
|
Waiting Period
NOT COMPLETED
|
4
|
6
|
|
Month 3 Visit
STARTED
|
1
|
1
|
|
Month 3 Visit
COMPLETED
|
1
|
1
|
|
Month 3 Visit
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
720 Shockwave Therapy Group
Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
Sham Shockwave Therapy
Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).
Sham shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
|---|---|---|
|
Weekly Therapy Sessions
Enrollment was halted; participants were unable to attend study visits due to COVID-19 restrictions.
|
8
|
3
|
|
Waiting Period
Enrollment was halted; participants were unable to attend study visits due to COVID-19 restrictions.
|
4
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
720 Shockwave Therapy Group
n=13 Participants
Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
Sham Shockwave Therapy
n=10 Participants
Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).
Sham shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 10.5 • n=13 Participants
|
51.2 years
STANDARD_DEVIATION 8.9 • n=10 Participants
|
51.7 years
STANDARD_DEVIATION 9.4 • n=23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=13 Participants
|
10 Participants
n=10 Participants
|
23 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12Population: No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.
The IIEF-EF questionnaire has a total score ranging from 0 - 30 with the higher score indicating better erectile function.
Outcome measures
| Measure |
720 Shockwave Therapy Group
n=13 Participants
Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
Sham Shockwave Therapy
n=10 Participants
Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).
Sham shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
|---|---|---|
|
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
Baseline
|
18.8 score on a scale
Standard Deviation 2.7
|
19.1 score on a scale
Standard Deviation 3.6
|
|
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
Month 1
|
18.4 score on a scale
Standard Deviation 7.1
|
17 score on a scale
Standard Deviation 4.5
|
|
International Index of Erectile Function (IIEF) Erectile Function Subdomain (EF) Scores.
Month 3
|
18 score on a scale
Standard Deviation NA
None of the data were analyzed because of insufficient participant numbers and power to draw conclusions.
|
26 score on a scale
Standard Deviation NA
None of the data were analyzed because of insufficient participant numbers and power to draw conclusions.
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12Population: No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.
The SEP consists of two questions: 1) Over the past 4 weeks, were you able to insert your penis into your partner's vagina? and 2) Over the past 4 weeks, did your erection last long enough for you to have successful intercourse? Reported will be the number of participants responding yes to the 2 questions.
Outcome measures
| Measure |
720 Shockwave Therapy Group
n=13 Participants
Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
Sham Shockwave Therapy
n=10 Participants
Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).
Sham shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
|---|---|---|
|
Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
Baseline
|
7 participants
|
2 participants
|
|
Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
Month 1
|
3 participants
|
2 participants
|
|
Number of Participants Responding 'Yes' to the Sexual Encounter Profile (SEP) Questionnaire
Month 3
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12Population: No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.
EHS has a total score ranging from 0 - 4 with the higher score indicating a better erection hardness
Outcome measures
| Measure |
720 Shockwave Therapy Group
n=13 Participants
Participants in this group will receive a total of 5 daily sessions of shockwave therapy within a week. Each therapy session will consist of 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
Shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver 720 shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
Sham Shockwave Therapy
n=10 Participants
Participants in this group will receive a total of 5 daily sessions of sham shockwave therapy within a week. Sham therapy will be applied to the penis and to the left and right crus (shaft near the base).
Sham shockwave therapy: Each therapy session, lasting about 20 minutes, will deliver sham shockwave therapy applied to the penis and to the left and right crus (shaft near the base)
|
|---|---|---|
|
Erection Hardness Score (EHS)
Baseline
|
2.9 score on a scale
Standard Deviation 0.3
|
2.8 score on a scale
Standard Deviation 0.6
|
|
Erection Hardness Score (EHS)
Month 1
|
3.4 score on a scale
Standard Deviation 0.5
|
3.1 score on a scale
Standard Deviation 0.4
|
|
Erection Hardness Score (EHS)
Month 3
|
3 score on a scale
Standard Deviation NA
None of the data were analyzed because of insufficient patient numbers and power to draw conclusions.
|
4 score on a scale
Standard Deviation NA
None of the data were analyzed because of insufficient patient numbers and power to draw conclusions.
|
Adverse Events
720 Shockwave Therapy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Shockwave Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ranjith Ramasamy, MD
University of Miami, Miller School of Medicine - Desai Sethi Urology Institute
Phone: 305-243-4562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place