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Effect of Functional Electrical Stimulation on Erectile Dysfunction

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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

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.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Functional Electrical Stimulation (FES) Device: FES- Sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Functional Electrical Stimulation on Erectile Dysfunction
Study Start Date : November 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: FES-sham
Functional Electro Stimulation (FES-sham)
Device: FES- Sham
Active Comparator: Intervention (FES)
functional electro stimulation
Device: Functional Electrical Stimulation (FES)
FES (50Hz / 500us)




Primary Outcome Measures :
  1. Erectile function with International Index of Erectile Function-5 questionnaire [ Time Frame: 2 times a week for 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
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Responsible Party: Cristiane Carboni, Professor, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT02284659    
Other Study ID Numbers: FUHSPortoAlegre
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders