Trial Outcomes & Findings for Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction (NCT NCT03067987)
NCT ID: NCT03067987
Last Updated: 2020-06-11
Results Overview
IIEF is a 15 item self-administered questionnaire assessing erectile dysfunction and treatment outcomes. Total IIEF score range from 5-25 with scores classifying erectile dysfunction (ED) as: severe (5-7); moderate (8-11); mild to moderate (12-16); mild (17-21) and no ED (22-25). The questionnaire will be assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). Time Frame: 7 months
COMPLETED
NA
103 participants
7 months
2020-06-11
Participant Flow
Participant milestones
| Measure |
720 Shockwave Therapy
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
|
600 Shockwave Therapy
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
53
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
| Measure |
720 Shockwave Therapy
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
|
600 Shockwave Therapy
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
720 Shockwave Therapy
n=50 Participants
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
|
600 Shockwave Therapy
n=53 Participants
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
n=5 Participants
|
52 years
n=7 Participants
|
52.25 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
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 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
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 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: 7 monthsIIEF is a 15 item self-administered questionnaire assessing erectile dysfunction and treatment outcomes. Total IIEF score range from 5-25 with scores classifying erectile dysfunction (ED) as: severe (5-7); moderate (8-11); mild to moderate (12-16); mild (17-21) and no ED (22-25). The questionnaire will be assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). Time Frame: 7 months
Outcome measures
| Measure |
720 Shockwave Therapy
n=40 Participants
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
|
600 Shockwave Therapy
n=40 Participants
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
|
|---|---|---|
|
International Index of Erectile Function (IIEF-EF) Questionnaire
SCORE AT BASELINE
|
18 score on a scale
Interval 11.0 to 25.0
|
17.9 score on a scale
Interval 11.0 to 25.0
|
|
International Index of Erectile Function (IIEF-EF) Questionnaire
SCORE AT 1 MONTHS
|
20.5 score on a scale
Interval 11.0 to 25.0
|
19.7 score on a scale
Interval 11.0 to 25.0
|
|
International Index of Erectile Function (IIEF-EF) Questionnaire
SCORE AT 3MONTHS
|
19.8 score on a scale
Interval 11.0 to 25.0
|
21.2 score on a scale
Interval 11.0 to 25.0
|
|
International Index of Erectile Function (IIEF-EF) Questionnaire
SCORE AT 6 MONTHS
|
20.9 score on a scale
Interval 11.0 to 25.0
|
21.4 score on a scale
Interval 11.0 to 25.0
|
SECONDARY outcome
Timeframe: 7 monthsEHS rates the hardness of erection on a scale of 1-4 assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). A score of 0 = penis does not enlarge; 1 = penis is larger but not hard; 2 = penis is hard but not hard enough for penetration; 3 = penis is hard enough for penetration but not completely hard; 4 = penis is completely hard and fully rigid.
Outcome measures
| Measure |
720 Shockwave Therapy
n=40 Participants
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
|
600 Shockwave Therapy
n=40 Participants
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
|
|---|---|---|
|
Erection Hardness Score (EHS)
SCORE AT BASELINE
|
2.5 score on a scale
Interval 0.0 to 4.0
|
2.7 score on a scale
Interval 0.0 to 4.0
|
|
Erection Hardness Score (EHS)
SCORE AT 1 MONTH
|
3.1 score on a scale
Interval 0.0 to 4.0
|
3 score on a scale
Interval 0.0 to 4.0
|
|
Erection Hardness Score (EHS)
SCORE AT 3 MONTHS
|
3.1 score on a scale
Interval 0.0 to 4.0
|
3 score on a scale
Interval 0.0 to 4.0
|
|
Erection Hardness Score (EHS)
SCORE AT 6 MONTHS
|
3.1 score on a scale
Interval 0.0 to 4.0
|
3.2 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 7 monthsSexual Encounter Profile (SEP) is a measure of efficacy of erectile dysfunction therapy. Improved responses to treatment will be reported as the percentage of participants that responds "yes" and non-improvement responses to treatment will be reported as the percentage of participants that responds "no".
Outcome measures
| Measure |
720 Shockwave Therapy
n=40 Participants
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
|
600 Shockwave Therapy
n=40 Participants
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
|
|---|---|---|
|
Sexual Encounter Profile (SEP)
SEP-Q2 (YES)
|
96 percentage of participants
|
95 percentage of participants
|
|
Sexual Encounter Profile (SEP)
SEP-Q2 (NO)
|
4 percentage of participants
|
5 percentage of participants
|
|
Sexual Encounter Profile (SEP)
SEP-Q3 (YES)
|
69 percentage of participants
|
70 percentage of participants
|
|
Sexual Encounter Profile (SEP)
SEP-Q3 (NO)
|
31 percentage of participants
|
30 percentage of participants
|
SECONDARY outcome
Timeframe: 7 monthsGlobal Assessment Question (GAQ) is a measure of perceived improvements in erectile function and sexual ability. Improved responses to treatment will be reported as the percentage of participants that responds "yes" and non-improvement responses to treatment will be reported as the percentage of participants that responds "no".
Outcome measures
| Measure |
720 Shockwave Therapy
n=40 Participants
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
|
600 Shockwave Therapy
n=40 Participants
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
|
|---|---|---|
|
Global Assessment Question (GAQ)
GAQ-Q1 (YES)
|
52 percentage of participants
|
53 percentage of participants
|
|
Global Assessment Question (GAQ)
GAQ-Q1 (NO)
|
48 percentage of participants
|
47 percentage of participants
|
|
Global Assessment Question (GAQ)
GAQ-Q2 (YES)
|
74 percentage of participants
|
73 percentage of participants
|
|
Global Assessment Question (GAQ)
GAQ-Q2(NO)
|
26 percentage of participants
|
27 percentage of participants
|
Adverse Events
720 Shockwave Therapy
600 Shockwave Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place