Effect of Functional Electrical Stimulation on Erectile Dysfunction

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02284659

Enrollment

Registered

2014-11-06

Start date

2014-11-30

Completion date

2015-03-31

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

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.

Interventions

DEVICEFunctional Electrical Stimulation (FES)

FES (50Hz / 500us)

DEVICEFES- Sham

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026