CClinicalTrials.gg
CompletedNCT02284659Updated Mar 6, 2015

Effect of Functional Electrical Stimulation on Erectile Dysfunction

An interventional study of Functional Electrical Stimulation (FES) and FES- Sham in Erectile Dysfunction, sponsored by Federal University of Health Science of Porto Alegre. Completed. Open to male participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Federal University of Health Science of Porto Alegre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Erectile Dysfunction

Browse trials for

03

In context

Erectile Dysfunction

682 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's enrollment of 22 is below the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Federal University of Health Science of Porto Alegre is the lead sponsor of 118 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
22 participants (actual)

Study arms

  • Sham comparator
    FES-sham

    Functional Electro Stimulation (FES-sham)

    Device: FES- Sham

  • Active comparator
    Intervention (FES)

    functional electro stimulation

    Device: Functional Electrical Stimulation (FES)

Interventions

  • DeviceFunctional Electrical Stimulation (FES)

    FES (50Hz / 500us)

  • DeviceFES- Sham
06

What researchers measure

Primary outcomes

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

    Time frame: 2 times a week for 30 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02284659
Lead sponsor
Federal University of Health Science of Porto Alegre
Responsible party
Cristiane Carboni (Professor, Federal University of Health Science of Porto Alegre) — Principal investigator
First posted
Nov 6, 2014
Start date
Nov 2014
Primary completion
Dec 2014
Completion
Mar 2015
Last update
Mar 6, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion