Radial Shockwave Therapy for Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Clinical Trial With Random Assignment to Evaluate the Efficacy and Safety of Radial Waves for the Treatment of Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596047
• Other study ID #: BMGC-4
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: October 2020

Study information

• Verified date: December 2019
• Source: Boston Medical Group
• Contact: José Saffon, Doctor
• Phone: 57 1 7446444
• Email: jsaffon[@]bostonmedical.com.co
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Colombia	Boston Medical Group Colombia	Bogotá	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Group

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average score of the IIEF-EF scale	The difference in the average score of the IIEF-EF scale in at least 5 points, between the score at the end of the treatment (6 weeks) and the basal score.	At the end of the treatment (6 weeks)
Secondary	IIEF-EF score after one month of follow-up	IIEF-EF score after one month of follow-up	Month 1 of follow-up
Secondary	Erection Hardness Score (EHS)	Erection Hardness Score (EHS), it is a unique Likert scale	At the end of treatment (6 weeks) and one month follow-up
Secondary	Incidence of adverse events	Frequency of adverse events	At the end of treatment (6 weeks)