Effect of Functional Electrical Stimulation on Erectile Dysfunction

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Device: FES- Sham; Device: Functional Electrical Stimulation (FES)

• Registration Number: NCT02284659
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-10-31
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-06
• Primary Completion: 2014-12
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FES-sham	FES- Sham	Functional Electro Stimulation (FES-sham)
Intervention (FES)	Functional Electrical Stimulation (FES)	functional electro stimulation

Primary Outcome Measures

Name	Time	Method
Erectile function with International Index of Erectile Function-5 questionnaire	2 times a week for 30 minutes