Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-02-07 @ 2:46 PM
Study NCT ID:
NCT02284659
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2014-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Functional Electrical Stimulation on Erectile Dysfunction
Sponsor:
Federal University of Health Science of Porto Alegre
Organization:
Study Overview
Official Title:
Effect of Functional Electrical Stimulation on Erectile Dysfunction
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: