Effect of Functional Electrical Stimulation on Erectile Dysfunction

Federal University of Health Science of Porto Alegre

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Device: Functional Electrical Stimulation (FES); Device: FES- Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02284659

FUHSPortoAlegre

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

22 participants in 2 patient groups

FES-sham

Sham Comparator group

Description:

Functional Electro Stimulation (FES-sham)

Treatment:

Device: FES- Sham

Intervention (FES)

Active Comparator group

Description:

functional electro stimulation

Treatment:

Device: Functional Electrical Stimulation (FES)