Trial Outcomes & Findings for Radial Shockwave Therapy for Erectile Dysfunction (NCT NCT03596047)
NCT ID: NCT03596047
Last Updated: 2024-09-23
Results Overview
The scale IIEF-EF score ranges from 0 to 30, a score less than 26 is considered to have erectile dysfunction. Using the IIEF-EF, erectile dysfunction severity categories are no ED (score ≥26 out of 30) mild (score 22-25), mild-to-moderate (score 17-21), moderate (score 11-16), and severe (score ≤10). The difference in the average score of the International Index Erectile Function-Erectile Function domain (IIEF-EF) scale in at least 5 points, between the score at the end of the treatment (6 weeks) and the basal score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
6 weeks (The end of the treatment)
Results posted on
2024-09-23
Participant Flow
Recruitment was carried out in two clinics over a period of 26 months.
Participant milestones
| Measure |
Standard Treatment + Radial Wave Therapy
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
Radial wave therapy: 6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
Standard Treatment + Placebo Therapy
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Placebo therapy: There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the "real" therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Standard Treatment + Radial Wave Therapy
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
Radial wave therapy: 6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
Standard Treatment + Placebo Therapy
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Placebo therapy: There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the "real" therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Treatment + Radial Wave Therapy
n=40 Participants
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
Radial wave therapy: 6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
Standard Treatment + Placebo Therapy
n=40 Participants
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Placebo therapy: There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the "real" therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 12.8 • n=40 Participants
|
48.5 years
STANDARD_DEVIATION 11.2 • n=40 Participants
|
48 years
STANDARD_DEVIATION 11.9 • n=80 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
80 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
26.7 kg/m2
STANDARD_DEVIATION 3.7 • n=40 Participants
|
26.8 kg/m2
STANDARD_DEVIATION 3.3 • n=40 Participants
|
26.75 kg/m2
STANDARD_DEVIATION 3.5 • n=80 Participants
|
|
International Index of Erectile Function-Erectile Function domain
|
16.3 units on a scale
STANDARD_DEVIATION 3.2 • n=40 Participants
|
16.4 units on a scale
STANDARD_DEVIATION 3.2 • n=40 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 3.2 • n=80 Participants
|
|
Erection Hardness Score
|
3 units on a scale
n=40 Participants
|
3 units on a scale
n=40 Participants
|
3 units on a scale
n=80 Participants
|
PRIMARY outcome
Timeframe: 6 weeks (The end of the treatment)Population: Patients with results at the end of therapy
The scale IIEF-EF score ranges from 0 to 30, a score less than 26 is considered to have erectile dysfunction. Using the IIEF-EF, erectile dysfunction severity categories are no ED (score ≥26 out of 30) mild (score 22-25), mild-to-moderate (score 17-21), moderate (score 11-16), and severe (score ≤10). The difference in the average score of the International Index Erectile Function-Erectile Function domain (IIEF-EF) scale in at least 5 points, between the score at the end of the treatment (6 weeks) and the basal score.
Outcome measures
| Measure |
Standard Treatment + Radial Wave Therapy
n=33 Participants
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
Radial wave therapy: 6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
Standard Treatment + Placebo Therapy
n=36 Participants
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Placebo therapy: There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the "real" therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
|---|---|---|
|
Change IIEF-EF Score
|
3.4 units on a scale
Interval 1.6 to 5.3
|
4.2 units on a scale
Interval 2.5 to 5.9
|
SECONDARY outcome
Timeframe: Month 1 of follow-up (Week 10)Population: Patients with results at week 10
The scale IIEF-EF score ranges from 0 to 30, a score less than 26 is considered to have erectile dysfunction. Using the IIEF-EF, erectile dysfunction severity categories are no ED (score ≥26 out of 30) mild (score 22-25), mild-to-moderate (score 17-21), moderate (score 11-16), and severe (score ≤10). The difference in the average score of the International Index Erectile Function-Erectile Function domain (IIEF-EF) scale in at least 5 points, between the score at the end of the treatment (6 weeks) and the basal score.
Outcome measures
| Measure |
Standard Treatment + Radial Wave Therapy
n=33 Participants
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
Radial wave therapy: 6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
Standard Treatment + Placebo Therapy
n=34 Participants
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Placebo therapy: There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the "real" therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
|---|---|---|
|
IIEF-EF Score After One Month of Follow-up
|
0.72 units on a scale
Interval -1.4 to 2.8
|
2.3 units on a scale
Interval 0.26 to 4.1
|
SECONDARY outcome
Timeframe: 6 weeks (At the end of treatment)Population: Patients with the results at 6 weeks
Erection Hardness Score (EHS), it is a unique Likert scale. EHS is a self-reported tool that scores erection hardness on a 4-point scale: 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. This outcome is the number of patients that increased the EHS by at least 1 point at week 6 after randomization
Outcome measures
| Measure |
Standard Treatment + Radial Wave Therapy
n=33 Participants
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
Radial wave therapy: 6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
Standard Treatment + Placebo Therapy
n=34 Participants
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Placebo therapy: There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the "real" therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
|---|---|---|
|
Erection Hardness Score (EHS)
|
15 Participants
|
14 Participants
|
Adverse Events
Standard Treatment + Radial Wave Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Treatment + Placebo Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Treatment + Radial Wave Therapy
n=37 participants at risk
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
Radial wave therapy: 6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
Standard Treatment + Placebo Therapy
n=39 participants at risk
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Placebo therapy: There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the "real" therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Not serius
|
2.7%
1/37 • Number of events 1 • 6 months
|
0.00%
0/39 • 6 months
|
Additional Information
Carolina Sandoval - Director Research
Boston Medical Group
Phone: +57 3133920816
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place