Effect of Functional Electrical Stimulation on Erectile Dysfunction

March 5, 2015 updated by: Cristiane Carboni, Federal University of Health Science of Porto Alegre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUHSPortoAlegre

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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