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Effect of Functional Electrical Stimulation on Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Electrical Stimulation (FES)
FES- Sham
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patient
  • 40 to 65 years of age, with stable marital relationship (6 months)
  • Diagnosis of erectile dysfunction (score of less than 22 IIEF5)
  • Clinical history of ED for at least 6 months

Exclusion Criteria:

  • A neurogenic (spinal cord injury, Parkinson's, MS, post prostatectomy)
  • Hypogonadism (total testosterone <300 ng / dl)
  • Patient reporting use of inhibitors or 5PDE FIC in the last 60 days
  • Diagnosis of coronary artery disease and / or cerebrovascular disease
  • Impossibility of understanding the goals, technical study and informed consent cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    FES-sham

    Intervention (FES)

    Arm Description

    Functional Electro Stimulation (FES-sham)

    functional electro stimulation

    Outcomes

    Primary Outcome Measures

    Erectile function with International Index of Erectile Function-5 questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    October 31, 2014
    Last Updated
    March 5, 2015
    Sponsor
    Federal University of Health Science of Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02284659
    Brief Title
    Effect of Functional Electrical Stimulation on Erectile Dysfunction
    Official Title
    Effect of Functional Electrical Stimulation on Erectile Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction. Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
    Detailed Description
    Introduction: Erectile dysfunction (ED) affects approximately 150 million men worldwide. The application of functional electrical stimulation (FES) has been used due to the high regenerative capacity of smooth muscle cells. This approach can be beneficial in the treatment of which usually has the ultimate causes cavernous smooth muscle degeneration. Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction. Methods: Randomized Clinical Trial will be selected in which 30 patients with erectile dysfunction. The men included will be randomized into two groups. The intervention group will conduct therapy with FES (50Hz / 500us) for 15 minutes with intensity below the motor threshold and the control group will use FES placebo. Two sessions will be held weekly for four weeks. Erectile function will be assessed using the validated questionnaire IIEF-5. The instrument will be completed by blinded researcher and the technique is randomized and the treatment done randomly. Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erectile Dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FES-sham
    Arm Type
    Sham Comparator
    Arm Description
    Functional Electro Stimulation (FES-sham)
    Arm Title
    Intervention (FES)
    Arm Type
    Active Comparator
    Arm Description
    functional electro stimulation
    Intervention Type
    Device
    Intervention Name(s)
    Functional Electrical Stimulation (FES)
    Intervention Description
    FES (50Hz / 500us)
    Intervention Type
    Device
    Intervention Name(s)
    FES- Sham
    Primary Outcome Measure Information:
    Title
    Erectile function with International Index of Erectile Function-5 questionnaire
    Time Frame
    2 times a week for 30 minutes

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male patient 40 to 65 years of age, with stable marital relationship (6 months) Diagnosis of erectile dysfunction (score of less than 22 IIEF5) Clinical history of ED for at least 6 months Exclusion Criteria: A neurogenic (spinal cord injury, Parkinson's, MS, post prostatectomy) Hypogonadism (total testosterone <300 ng / dl) Patient reporting use of inhibitors or 5PDE FIC in the last 60 days Diagnosis of coronary artery disease and / or cerebrovascular disease Impossibility of understanding the goals, technical study and informed consent cognitive impairment

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Functional Electrical Stimulation on Erectile Dysfunction

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