Effect of Functional Electrical Stimulation on Erectile Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Functional Electrical Stimulation on Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Functional Electrical Stimulation (FES)
* Device: FES- Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: FES-sham<br>Functional Electro Stimulation (FES-sham) | Device: FES- Sham<br> <br> |
| Active Comparator: Intervention (FES)<br>functional electro stimulation | Device: Functional Electrical Stimulation (FES)<br>* FES (50Hz / 500us)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function with International Index of Erectile Function-5 questionnaire |  | 2 times a week for 30 minutes |