Erectile DysfunctionNCT03596047
Radial Shockwave Therapy for Erectile Dysfunction
A study testing Radial wave therapy in people with Erectile Dysfunction, run by Boston Medical Group at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Radial wave therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteColombia
- Study dates
- 19 Apr 2018to 9 Mar 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial With Random Assignment to Evaluate the Efficacy and Safety of Radial Waves for the Treatment of Erectile Dysfunction
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.
Read more
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Radial wave therapy, Placebo therapy
- Keywords
- radial wave therapy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial wave therapyDevice
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.
Placebo therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment + Radial wave therapy | Experimental | Sildenafil according to the degree of patient involvement + 6 sessions of radial waves. Receives: Device: Radial wave therapy |
| Standard treatment + Placebo therapy | Placebo comparator | Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy. Receives: Device: Placebo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks (The end of the treatment)
Secondary outcomes (2)
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.
Measured: 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
Measured: 6 weeks (At the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start19 Apr 2018
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Saffon, Doctor, Principal investigator, Boston Medicval Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596047
- Sponsor's protocol ID
- BMGC-4
- Status last verified
- Oct 2023
- First submitted
- 13 Jun 2018
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sandoval-Salinas C, Saffon JP, Martinez JM, Corredor HA, Gallego A. Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial. J Sex Med. 2022 May;19(5):738-744. doi: 10.1016/j.jsxm.2022.02.010. Epub 2022 Mar 24.
PubMed 35341724