Erectile Dysfunction
Conditions
Keywords
radial wave therapy
Brief summary
Objective: To evaluate the efficacy and safety of radial shock waves for the treatment of erectile dysfunction \[ED\]. Patients and methods: Randomized, double-blind clinical trial. The study will include patients of legal age with diagnosis of ED and score on the International Index of Erectile Function \[IIEF-EF\] scale between 11 and 21 points, who voluntarily decide to participate and sign the informed consent. Patients with bladder cancer, prostate cancer or active colon, ED of psychological origin, any psychiatric disorder, spinal cord injury, clinical suspicion of hypogonadism (score on the Aging Males' Symptoms scale greater than 36), infections or active lesions of the penis or pubic area, ED secondary to treatment with medications (antiandrogenic therapy, use of corticosteroids, anti-Parkinson's, antipsychotics), radical prostatectomy or other radical pelvic surgery, history of pelvic radiotherapy, penile implantation, or endocrine diseases that occur with ED (acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgenic deficiency), sickle cell anemia, and anticoagulated patients will be excluded. Patients will be randomly assigned to one of the following treatment arms: * Arm 1 (Standard treatment (oral sildenafil) + Radial wave therapy) * Arm 2 (Standard treatment (oral sildenafil) + Placebo therapy) Measurements will be made of the Erection Hardness Score \[EHS\] and IIEF-EF scale scores, of the use of medication and of the possible adverse events of the therapy, at the beginning and end of the treatment, and one month after the therapies are finished.
Detailed description
Background: Radial shock waves are an effective therapy for the management of various problems at the muscular and joint level, thanks to the effect it has on the activation of microcirculation. The effect of these waves on patients with erectile dysfunction is currently unknown; however, it is considered possible to help recovery in patients with vascular origin dysfunction by increasing microcirculation blood flow in this area. Objective: To evaluate the efficacy and safety of radial shock waves for the treatment of erectile dysfunction. Patients and methods: Randomized, double-blind clinical trial. The study will include patients of legal age with diagnosis of ED and score on the IIEF-EF scale between 11 and 21 points, who voluntarily decide to participate and sign the informed consent. Patients with bladder cancer, prostate cancer or active colon, ED of psychological origin, any psychiatric disorder, spinal cord injury, clinical suspicion of hypogonadism (AMS greater than 36), infections or active lesions of the penis or pubic area, ED secondary to treatment with medications (antiandrogenic therapy, use of corticosteroids, anti-Parkinson's, antipsychotics), radical prostatectomy or other radical pelvic surgery, history of pelvic radiotherapy, penile implantation, or endocrine diseases that occur with ED (acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgenic deficiency), sickle cell anemia, and anticoagulated patients will be excluded. Patients will be randomly assigned to one of the following treatment arms: * Arm 1 (Standard treatment (oral sildenafil) + Radial wave therapy): Sildenafil according to the degree of patient involvement + 6 sessions of radial waves. A weekly session of radial waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 17Hz, the frequency should increase to 22HZ the first 500 impulses to create mild anesthesia in the area; in all radial wave sessions, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. * Arm 2 (Standard treatment (oral sildenafil) + Placebo therapy): Sildenafil according to the patient's degree of affectation + 6 sessions of 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 radial wave sessions, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. Measurements will be made of the EHS and IIEF-EF scale scores, of the use of medication and of the possible adverse events of the therapy, at the beginning and end of the treatment, and one month after the therapies are finished.
Interventions
DEVICERadial 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.
DEVICEPlacebo 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.
Sponsors
Boston Medical Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The Shockwave therapy machine has a device to prevent the patient from receiving the radial wave. This device will be changed for the clinic administrator. Change device placebo wave therapy, using the respective device t
Intervention model description
Randomized, double-blind clinical trial.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men older than 18 years * Erectile dysfunction present more for more than 3 months in more than 50% of intercourse. * IIEF-EF score between 11 and 21. * Patient who agrees to enter the study through the signing of an informed consent.
Exclusion criteria
* EHS score of 4 * Bladder, prostate or colon cancer. * ED of psychological origin. * Patients with spinal cord injury. * Patients with anticoagulant use. * Patients with sickle cell anemia. * Patients with clinical suspicion of hypogonadism (AMS greater than 36, Annex 1). * Patients with infections or active lesions of the penis or pubic area. * Patients with ED secondary to drug treatment (antiandrogenic therapy, antidepressants, use of corticosteroids, antiparkinsonians, antipsychotics). * Radical prostatectomy or other radical pelvic surgery. * Antecedents of pelvic radiotherapy. * Patients with penile implant. * Endocrine diseases that occur with ED: acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgenic deficiency. * Patients with neurological diseases (Parkinson's, CVD, dementia of any origin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change IIEF-EF Score | 6 weeks (The end of the treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IIEF-EF Score After One Month of Follow-up | Month 1 of follow-up (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. |
| Erection Hardness Score (EHS) | 6 weeks (At the end of treatment) | 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 |
Countries
Colombia
Contacts
PRINCIPAL_INVESTIGATORJose Saffon, Doctor
Boston Medicval Group
Participant flow
Recruitment details
Recruitment was carried out in two clinics over a period of 26 months.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Standard Treatment + Radial Wave Therapy | Total | Standard Treatment + Placebo Therapy |
|---|---|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 12.8 | 48 years STANDARD_DEVIATION 11.9 | 48.5 years STANDARD_DEVIATION 11.2 |
| Body Mass Index | 26.7 kg/m2 STANDARD_DEVIATION 3.7 | 26.75 kg/m2 STANDARD_DEVIATION 3.5 | 26.8 kg/m2 STANDARD_DEVIATION 3.3 |
| Erection Hardness Score | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| International Index of Erectile Function-Erectile Function domain | 16.3 units on a scale STANDARD_DEVIATION 3.2 | 16.3 units on a scale STANDARD_DEVIATION 3.2 | 16.4 units on a scale STANDARD_DEVIATION 3.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 40 Participants | 80 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 39 |
| other Total, other adverse events | 2 / 37 | 1 / 39 |
| serious Total, serious adverse events | 0 / 37 | 0 / 39 |
Outcome results
Primary
Change IIEF-EF Score
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.
Time frame: 6 weeks (The end of the treatment)
Population: Patients with results at the end of therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Treatment + Radial Wave Therapy | Change IIEF-EF Score | 3.4 units on a scale |
| Standard Treatment + Placebo Therapy | Change IIEF-EF Score | 4.2 units on a scale |
Secondary
Erection Hardness Score (EHS)
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
Time frame: 6 weeks (At the end of treatment)
Population: Patients with the results at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment + Radial Wave Therapy | Erection Hardness Score (EHS) | 15 Participants |
| Standard Treatment + Placebo Therapy | Erection Hardness Score (EHS) | 14 Participants |
Secondary
IIEF-EF Score After One Month of Follow-up
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.
Time frame: Month 1 of follow-up (Week 10)
Population: Patients with results at week 10
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Treatment + Radial Wave Therapy | IIEF-EF Score After One Month of Follow-up | 0.72 units on a scale |
| Standard Treatment + Placebo Therapy | IIEF-EF Score After One Month of Follow-up | 2.3 units on a scale |