Effect of Functional Electrical Stimulation on Erectile Dysfunction
NCT ID: NCT02284659
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2014-11-30
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
NCT06425211
Functional Electrical Stimulation in Cardiac Patients
NCT02088138
DualStim Therapy With or Without Umbilical Cord Derived Wharton's Jelly for Erectile Dysfunction
NCT04424394
Bioeletric Stimulation in Patients With Chronic Kidney Failure
NCT04608422
Muscle Delay Characterization
NCT04094571
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FES-sham
Functional Electro Stimulation (FES-sham)
FES- Sham
Intervention (FES)
functional electro stimulation
Functional Electrical Stimulation (FES)
FES (50Hz / 500us)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Functional Electrical Stimulation (FES)
FES (50Hz / 500us)
FES- Sham
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
70 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of Health Science of Porto Alegre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cristiane Carboni
Professor
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FUHSPortoAlegre
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.