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Completed

NCT Number: NCT02284659

Effect of Functional Electrical Stimulation on Erectile Dysfunction

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Electrical Stimulation (FES)

Device

FES (50Hz / 500us)

FES- Sham

Device

Primary outcomes

  1. Erectile function with International Index of Erectile Function-5 questionnaire

    Time frame: 2 times a week for 30 minutes

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Nov 6, 2014
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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