Trial Outcomes & Findings for Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction (NCT NCT04136288)
NCT ID: NCT04136288
Last Updated: 2024-11-12
Results Overview
Resistive Index (RI) is a measure of resistance to blood flow within the right penile arteries. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with a poorer prognosis. Lower values are associated with a better prognosis.
COMPLETED
NA
6 participants
Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hour
2024-11-12
Participant Flow
Participant milestones
| Measure |
Males With Erectile Dysfunction (ED)
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
31.64 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourResistive Index (RI) is a measure of resistance to blood flow within the right penile arteries. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with a poorer prognosis. Lower values are associated with a better prognosis.
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Change in Right Resistive Index
|
75.67 cm/second
Interval 64.0 to 100.0
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourPeak systolic velocity (PSV): The maximum velocity of blood flow during erection. Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A PSV higher than 35 cm/sec is regarded as normal, a 25-35 cm/sec may indicate moderate-to-mean arterial damage, and a PSV lower than 25 may indicate the presence of severe arteriopathy.
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Change in Right Peak Systolic Velocity
|
16.27 cm/second
Interval 3.7 to 50.5
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourDiastolic Velocity (DV) represents the velocity of right-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Change in Right Diastolic Velocity
|
13.42 cm/second
Interval 0.0 to 26.7
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourMeasured using a self-reported Erection Hardness Score (EHS) scale options from 0 (minimum) to 4 (maximum). 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, or 4-Penis is completely hard and fully rigid. A lower score indicates a worse outcome. A higher score indicates a better outcome.
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Erection Hardness Score (EHS)
Number of participants who answered 4 on scale.
|
0 participants
|
|
Erection Hardness Score (EHS)
Number of participants who answered 0 on scale.
|
0 participants
|
|
Erection Hardness Score (EHS)
Number of participants who answered 1 on scale.
|
1 participants
|
|
Erection Hardness Score (EHS)
Number of participants who answered 2 on scale.
|
1 participants
|
|
Erection Hardness Score (EHS)
Number of participants who answered 3 on scale.
|
4 participants
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourMeasured using a self-reported International Index of Erectile Function questionnaire (IIEF - EF) consisting of 6 questions regarding the participants erectile function for the past 4 weeks. The questionnaire utilizes a scale of 0 (minimum) to 5 (maximum). A lower score indicates a worse outcome. A higher score indicates a better outcome. Questions 1-2 scale: 0=No sexual activity, 1= Almost never/never, 2= A few times (much less than half the time),3= Sometimes (about half the time), 4= Most times (much more than half the time),5= Almost always/always Questions 3-4 scale: 0=Did not attempt, 1=Almost never/never, 2= A few times (much less than half the time), 3= Sometimes (about half the time), 4= Most times (much more than half the time), 5= Almost always/always Question 5 scale:0=Did not attempt intercourse,1= Extremely difficult, 2=Very Difficult, 3=Difficult, 4= Slightly Difficult, 5= No Difficult Question 6 scale: 1= Very low, 2=Low, 3=Moderate, 4=High, 5= Very high
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse,how often were you able to maintain your erection after you entered your partner? · 0
|
2 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How often were you able to get an erection during sexual activity? · 0
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How often were you able to get an erection during sexual activity? · 1
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How often were you able to get an erection during sexual activity? · 2
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How often were you able to get an erection during sexual activity? · 3
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How often were you able to get an erection during sexual activity? · 4
|
2 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How often were you able to get an erection during sexual activity? · 5
|
0 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you had erections with stimulation, how often were your erections hard enough for penetration? · 0
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you had erections with stimulation, how often were your erections hard enough for penetration? · 1
|
2 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you had erections with stimulation, how often were your erections hard enough for penetration? · 2
|
0 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you had erections with stimulation, how often were your erections hard enough for penetration? · 3
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you had erections with stimulation, how often were your erections hard enough for penetration? · 4
|
0 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you had erections with stimulation, how often were your erections hard enough for penetration? · 5
|
2 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you attempted sexual intercourse, how often were you able to penetrate your partner? · 0
|
2 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you attempted sexual intercourse, how often were you able to penetrate your partner? · 1
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you attempted sexual intercourse, how often were you able to penetrate your partner? · 2
|
0 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you attempted sexual intercourse, how often were you able to penetrate your partner? · 3
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you attempted sexual intercourse, how often were you able to penetrate your partner? · 4
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
When you attempted sexual intercourse, how often were you able to penetrate your partner? · 5
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse,how often were you able to maintain your erection after you entered your partner? · 1
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse,how often were you able to maintain your erection after you entered your partner? · 2
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse,how often were you able to maintain your erection after you entered your partner? · 3
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse,how often were you able to maintain your erection after you entered your partner? · 4
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse,how often were you able to maintain your erection after you entered your partner? · 5
|
0 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse, how difficult was it to maintain your erection to completion of intercourse? · 0
|
2 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse, how difficult was it to maintain your erection to completion of intercourse? · 1
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse, how difficult was it to maintain your erection to completion of intercourse? · 2
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse, how difficult was it to maintain your erection to completion of intercourse? · 3
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse, how difficult was it to maintain your erection to completion of intercourse? · 4
|
0 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
During intercourse, how difficult was it to maintain your erection to completion of intercourse? · 5
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How would you rate your confidence that you could get and keep an erection? · 0
|
0 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How would you rate your confidence that you could get and keep an erection? · 1
|
2 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How would you rate your confidence that you could get and keep an erection? · 2
|
1 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How would you rate your confidence that you could get and keep an erection? · 3
|
3 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How would you rate your confidence that you could get and keep an erection? · 4
|
0 Participants
|
|
International Index of Erectile Function (IIEF - EF) Questionnaire
How would you rate your confidence that you could get and keep an erection? · 5
|
0 Participants
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourMeasured using a self-reported Sexual Encounter Profile (SEP) Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options. No, indicates a worse outcome. Yes, indicates a better outcome.
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Sexual Encounter Profile (SEP) Questionnaire
Q2: Over the past 4 weeks, were you able to insert your penis into your partner's vagina. · Answered Yes
|
3 Participants
|
|
Sexual Encounter Profile (SEP) Questionnaire
Q2: Over the past 4 weeks, were you able to insert your penis into your partner's vagina. · Answered No
|
3 Participants
|
|
Sexual Encounter Profile (SEP) Questionnaire
Q3:Over the past 4 weeks, you had an erection last long enough to have successful intercourse. · Answered Yes
|
2 Participants
|
|
Sexual Encounter Profile (SEP) Questionnaire
Q3:Over the past 4 weeks, you had an erection last long enough to have successful intercourse. · Answered No
|
4 Participants
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourMeasured using a self-reported Global Assessment Questionnaire consisting of 2 questions. The questionnaire utilized Yes or No response options. No, indicates a worse outcome. Yes, indicates a better outcome.
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Global Assessment Questionnaire
Q1: Over the past 4 week, has the treatment you have been taking improved your erectile function? · Answered Yes
|
1 Participants
|
|
Global Assessment Questionnaire
Q1: Over the past 4 week, has the treatment you have been taking improved your erectile function? · Answered No
|
5 Participants
|
|
Global Assessment Questionnaire
Q1: Over the past 4 week, has the treatment you have been taking improved your erectile function? · No response
|
0 Participants
|
|
Global Assessment Questionnaire
Q2: Has the treatment improved your ability to engage in sexual activity over the past 4 weeks? · Answered Yes
|
0 Participants
|
|
Global Assessment Questionnaire
Q2: Has the treatment improved your ability to engage in sexual activity over the past 4 weeks? · Answered No
|
4 Participants
|
|
Global Assessment Questionnaire
Q2: Has the treatment improved your ability to engage in sexual activity over the past 4 weeks? · No response
|
2 Participants
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourMeasured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second A Peak Systolic Velocity of 25-35 cm/s or higher is considered normal. This reflects the maximum velocity of blood flow during erection.
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Change in Left Peak Systolic Velocity
|
26.63 cm/second
Interval 4.2 to 85.9
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourDiastolic Velocity (DV) represents the velocity of left-side blood flow during the resting phase of the cardiac cycle. A DV less than 5 cm/s is considered normal (better). A DV less considered abnormal (worse). Measured using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Change in Left Diastolic Velocity
|
14.72 cm/second
Interval 7.2 to 32.0
|
PRIMARY outcome
Timeframe: Treatment 6 Final Shockwave treatment (pre-procedure, intra-procedure, post procedure) approximately 1 hourResistive Index (RI) is a measure of resistance to blood flow within the left penile arteries. Measured Left Resistive Index using a Color Duplex Doppler Ultrasound (CDDU) measured in cm/second Elevated values are associated with poorer prognosis. Lower values are associated with a better prognosis.
Outcome measures
| Measure |
Males With Erectile Dysfunction (ED)
n=6 Participants
Males diagnosed with erectile dysfunction (ED) for over a year, but less than 5 years, will receive shock wave therapy via MoreNova device
MoreNova: Shockwave therapy delivered to the genital area with low dose shocks
|
|---|---|
|
Left Resistive Index
|
73.5 cm/second
Interval 60.0 to 84.0
|
Adverse Events
Males With Erectile Dysfunction (ED)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chandler Chapman, DHSc, MPH, Senior Clinical Research Coordinator
Mayo Clinic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place