Effect of Functional Electrical Stimulation on Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Effect of Functional Electrical Stimulation on Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284659
• Other study ID #: FUHSPortoAlegre
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: March 5, 2015
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Functional Electrical Stimulation (FES)
FES (50Hz / 500us)
• FES- Sham

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Outcome

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