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Effectiveness And Safety Of Two Protocols For The Treatment Of Erectile Dysfunction With Low-Density Shock Waves

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ClinicalTrials.gov Identifier: NCT02683044
Recruitment Status : Unknown
Verified July 2016 by Instituto para la Evaluación de la Calidad y Atención en Salud.
Recruitment status was:  Recruiting
First Posted : February 17, 2016
Last Update Posted : July 18, 2016
Sponsor:
Collaborator:
Boston Medical Group
Information provided by (Responsible Party):
Instituto para la Evaluación de la Calidad y Atención en Salud

Brief Summary:

Randomized, experimental, non-inferiority clinical trial to determine the comparative effectiveness and safety of two protocols used in the treatment of Erectile Dysfunction (ED) with Low-Density Shock Waves (Li-ESWT), for patients seen at the Boston Medical Group's Bogota center. Protocol 1: Consists of five sessions, one per week, with 3000 pulses at 0,15 mg/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 2000 pulses to the body of the penis and 1000 pulses at its base. Total duration: 5 weeks. Protocol 2: Consists of six sessions, two per week, with 1500 pulses each one at 0.1 mJ/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 900 pulses to the body of the penis and 600 pulses at its base. Total duration: 3 weeks.

Outcome variables: Erection Hardness Score (EHS). International Index of Erectile Function, 5-item version (IIEF-5). Penile blood flow.

Evaluation at 1, 3 and 6 months after completing each of the Li-ESWT protocols.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Procedure: Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial To Evaluate The Comparative Effectiveness And Safety Of Two Protocols For The Treatment Of Erectile Dysfunction With Low-Density Shock Waves
Study Start Date : February 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Li-ESWT 5 weeks
Consists of five sessions of Low-Intensity Extracorporeal Shock Wave Therapy , one per week, with 3000 pulses at 0,15 mg/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 2000 pulses to the body of the penis and 1000 pulses at its base. Total duration: 5 weeks.
Procedure: Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)
Sessions of shocks to the body of the penis

Active Comparator: Li-ESWT 3 weeks
Consists of six sessions of Low-Intensity Extracorporeal Shock Wave Therapy , two per week, with 1500 pulses each one at 0.1 mJ/mm2, at a frequency of 4 Hz. The distribution of the shocks will be 900 pulses to the body of the penis and 600 pulses at its base. Total duration: 3 weeks.
Procedure: Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)
Sessions of shocks to the body of the penis




Primary Outcome Measures :
  1. Erection Hardness Score (EHS) [ Time Frame: 1 month after completing each protocol ]

Secondary Outcome Measures :
  1. Penile blood flow [ Time Frame: 1 month after completing each protocol ]
    Penile blood flow with vasoactive stimuli of prostaglandin (VSP), measured by color echo-doppler

  2. International Index of Erectile Function, 5-item version (IIEF-5) [ Time Frame: 1, 3 and 6 months after completing each protocol ]
  3. Erection Hardness Score (EHS) [ Time Frame: 3 and 6 months after completing each protocol ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of ED for more than 3 months in over 50% of sexual intercourses.
  • EHS score under or equal to 3.
  • IIEF-5 score under or equal to 21.
  • Patients who agree to participate in the trial through signed informed consent.

Exclusion Criteria:

  • Active bladder, prostate or colon cancer.
  • Patients with ED having a psychological origin.
  • Any psychiatric pathology, spinal cord injury or anatomical penile dysfunction.
  • Patients with INR over 3, ordered by a cardiologist.
  • Patients with clinically suspected hypogonadism (AMS under 36).
  • Patients with active infections or lesions on the penis or pubic area.

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): NCT02683044


Contacts
Contact: Hector A Corredor, MD 57-1-7431857 hcorredor@bostonmedical.com.co

Locations
Colombia
Boston Medical Group Recruiting
Bogota, Distrito Capital, Colombia, 111321
Contact: Jose P Saffon, MD    57-3164647411    jsaffon@bostonmedical.com.co   
Principal Investigator: Jose P Saffon, MD         
Sponsors and Collaborators
Instituto para la Evaluación de la Calidad y Atención en Salud
Boston Medical Group
Investigators
Principal Investigator: Jose P Saffon, MD Boston Medical Group

Publications:

Responsible Party: Instituto para la Evaluación de la Calidad y Atención en Salud
ClinicalTrials.gov Identifier: NCT02683044     History of Changes
Other Study ID Numbers: IECAS-BMG-01
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Instituto para la Evaluación de la Calidad y Atención en Salud:
Erectile dysfunction
Low-Density Shock Waves
Randomized Clinical Trial

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders