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Radial Shockwave Therapy for Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT03596047
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Medical Group

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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Radial wave therapy Device: Placebo therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind clinical trial.
Masking: Double (Participant, 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

Primary Purpose: Treatment
Official Title: Clinical Trial With Random Assignment to Evaluate the Efficacy and Safety of Radial Waves for the Treatment of Erectile Dysfunction
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard treatment + Radial wave therapy
Sildenafil according to the degree of patient involvement + 6 sessions of radial waves.
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 Comparator: Standard treatment + Placebo therapy
Sildenafil according to the patient's degree of affectation + 6 sessions of placebo therapy.
Device: 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.




Primary Outcome Measures :
  1. Average score of the IIEF-EF scale [ Time Frame: At the end of the treatment (6 weeks) ]
    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.


Secondary Outcome Measures :
  1. IIEF-EF score after one month of follow-up [ Time Frame: Month 1 of follow-up ]
    IIEF-EF score after one month of follow-up

  2. Erection Hardness Score (EHS) [ Time Frame: At the end of treatment (6 weeks) and one month follow-up ]
    Erection Hardness Score (EHS), it is a unique Likert scale

  3. Incidence of adverse events [ Time Frame: At the end of treatment (6 weeks) ]
    Frequency of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596047


Contacts
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Contact: José Saffon, Doctor 57 1 7446444 ext 780 - 106 jsaffon@bostonmedical.com.co
Contact: Carolina Sandoval, Magister 57 1 7446444 ext 780 csandoval@bostonmedical.com.co

Locations
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Colombia
Boston Medical Group Colombia Recruiting
Bogotá, Cundinamarca, Colombia, 11022
Contact: Carolina Sandoval    57 3208899777    csandoval@bostonmedical.com.co   
Sponsors and Collaborators
Boston Medical Group
Investigators
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Principal Investigator: Jose Saffon, Doctor Boston Medicval Group

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Responsible Party: Boston Medical Group
ClinicalTrials.gov Identifier: NCT03596047     History of Changes
Other Study ID Numbers: BMGC-4
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Group:
radial wave therapy
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents