An interventional study of Radial wave therapy and Placebo therapy in Erectile Dysfunction, sponsored by Boston Medical Group. Completed at 1 site in Colombia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Boston Medical Group · Not applicable, Interventional, and Treatment
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:
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.
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:
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Boston Medical Group is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
Device: Radial wave therapy
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Device: Placebo 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.
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
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)
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)
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)
Recruitment was carried out in two clinics over a period of 26 months.
| Milestone | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy |
|---|---|---|
| Started | 40 | 40 |
| Completed | 33 | 34 |
| Not completed | 7 | 6 |
| Withdrew: Withdrawal by subject | 7 | 4 |
| Withdrew: Lost to follow-up | 0 | 2 |
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.
| units on a scale | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy |
|---|---|---|
| Change IIEF-EF Score | 3.4 (1.6 to 5.3) | 4.2 (2.5 to 5.9) |
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.
| units on a scale | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy |
|---|---|---|
| IIEF-EF Score After One Month of Follow-up | 0.72 (-1.4 to 2.8) | 2.3 (0.26 to 4.1) |
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
| Participants | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy |
|---|---|---|
| Erection Hardness Score (EHS) | 15 | 14 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Treatment + Radial Wave Therapy | 0/37 (0%) | 0/37 (0%) | 2/37 (5.4%) |
| Standard Treatment + Placebo Therapy | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) |
| Event | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy |
|---|---|---|
| Not seriusSkin and subcutaneous tissue disorders | 1/37 | 1/39 |
| Not seriusSkin and subcutaneous tissue disorders | 1/37 | 0/39 |
All randomized patients
| Age, Continuous(years) | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy | Total |
|---|---|---|---|
| Mean | 47.7 ± 12.8 | 48.5 ± 11.2 | 48 ± 11.9 |
| Sex: Female, Male(Participants) | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 40 | 40 | 80 |
| Race and Ethnicity Not Collected(Participants) | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body Mass Index(kg/m2) | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy | Total |
|---|---|---|---|
| Mean | 26.7 ± 3.7 | 26.8 ± 3.3 | 26.75 ± 3.5 |
| International Index of Erectile Function-Erectile Function domain(units on a scale) | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy | Total |
|---|---|---|---|
| Mean | 16.3 ± 3.2 | 16.4 ± 3.2 | 16.3 ± 3.2 |
| Erection Hardness Score(units on a scale) | Standard Treatment + Radial Wave Therapy | Standard Treatment + Placebo Therapy | Total |
|---|---|---|---|
| Median | 3 (1 to 3) | 3 (2 to 3) | 3 (1 to 3) |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Mar 2021, 34 months.
Results were first posted in Sep 2024, 3 years 6 months after primary completion.
Of 137 interventional studies with no phase under Erectile Dysfunction, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's 34 months is close to that.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Boston Medical Group