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Effect of Functional Electrical Stimulation on Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02284659
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Cristiane Carboni, Federal University of Health Science of Porto Alegre

Tracking Information
First Submitted Date  ICMJE October 31, 2014
First Posted Date  ICMJE November 6, 2014
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE November 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2014)
Erectile function with International Index of Erectile Function-5 questionnaire [ Time Frame: 2 times a week for 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Functional Electrical Stimulation on Erectile Dysfunction
Official Title  ICMJE Effect of Functional Electrical Stimulation on Erectile Dysfunction
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE
  • Device: Functional Electrical Stimulation (FES)
    FES (50Hz / 500us)
  • Device: FES- Sham
Study Arms  ICMJE
  • Sham Comparator: FES-sham
    Functional Electro Stimulation (FES-sham)
    Intervention: Device: FES- Sham
  • Active Comparator: Intervention (FES)
    functional electro stimulation
    Intervention: Device: Functional Electrical Stimulation (FES)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2014)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02284659
Other Study ID Numbers  ICMJE FUHSPortoAlegre
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cristiane Carboni, Federal University of Health Science of Porto Alegre
Study Sponsor  ICMJE Federal University of Health Science of Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of Health Science of Porto Alegre
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP