NCT02284659

Effect of Functional Electrical Stimulation on Erectile Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Federal University of Health Science of Porto Alegre · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Functional Electrical Stimulation (FES)	FES (50Hz / 500us)
DEVICE	FES- Sham

Timeline

• Start date: 2014-11-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2014-11-06
• Last updated: 2015-03-06