Radial Shockwave Therapy for Erectile Dysfunction

NCT03596047 | Completed Results

• 1 other identifier: BMGC-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

radial wave therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks (The end of the treatment)

Secondary Outcomes (2)

• IIEF-EF Score After One Month of Follow-up

  Month 1 of follow-up (Week 10)

• Erection Hardness Score (EHS)

  6 weeks (At the end of treatment)

Study Arms (2)

Standard treatment + Radial wave therapy

EXPERIMENTAL

Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.

Device: Radial wave therapy

Standard treatment + Placebo therapy

PLACEBO COMPARATOR

Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.

Device: Placebo therapy

Interventions

Radial wave therapy DEVICE

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 + Radial wave therapy

Placebo therapy DEVICE

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.

Standard treatment + Placebo therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Group: lead

Study Sites (1)

Boston Medical Group Colombia

Bogotá, Cundinamarca, 11022, Colombia

Location

Related Publications (1)

• 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.

  PMID: 35341724 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Results Point of Contact

• Title: Carolina Sandoval - Director Research
• Organization: Boston Medical Group

csandoval@bostonmedical.com.co

+57 3133920816

Study Officials

• Jose Saffon, Doctor

  Boston Medicval Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind clinical trial.

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 23, 2018
• Study Start: April 19, 2018
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: March 19, 2026
• Results First Posted: September 23, 2024

Record last verified: 2023-10

Locations

CO (1)