Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-01-06 @ 4:47 AM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-07-22', 'releaseDate': '2016-06-13'}, {'resetDate': '2019-02-15', 'releaseDate': '2018-10-07'}], 'estimatedResultsFirstSubmitDate': '2016-06-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2014-10-31', 'studyFirstSubmitQcDate': '2014-11-05', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erectile function with International Index of Erectile Function-5 questionnaire', 'timeFrame': '2 times a week for 30 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.\n\nExpected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.', 'detailedDescription': '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.\n\nObjective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.\n\nMethods: 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.\n\nExpected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male patient\n* 40 to 65 years of age, with stable marital relationship (6 months)\n* Diagnosis of erectile dysfunction (score of less than 22 IIEF5)\n* Clinical history of ED for at least 6 months\n\nExclusion Criteria:\n\n* A neurogenic (spinal cord injury, Parkinson's, MS, post prostatectomy)\n* Hypogonadism (total testosterone \\<300 ng / dl)\n* Patient reporting use of inhibitors or 5PDE FIC in the last 60 days\n* Diagnosis of coronary artery disease and / or cerebrovascular disease\n* Impossibility of understanding the goals, technical study and informed consent cognitive impairment"}, 'identificationModule': {'nctId': 'NCT02284659', 'briefTitle': 'Effect of Functional Electrical Stimulation on Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Health Science of Porto Alegre'}, 'officialTitle': 'Effect of Functional Electrical Stimulation on Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'FUHSPortoAlegre'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'FES-sham', 'description': 'Functional Electro Stimulation (FES-sham)', 'interventionNames': ['Device: FES- Sham']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention (FES)', 'description': 'functional electro stimulation', 'interventionNames': ['Device: Functional Electrical Stimulation (FES)']}], 'interventions': [{'name': 'Functional Electrical Stimulation (FES)', 'type': 'DEVICE', 'description': 'FES (50Hz / 500us)', 'armGroupLabels': ['Intervention (FES)']}, {'name': 'FES- Sham', 'type': 'DEVICE', 'armGroupLabels': ['FES-sham']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Health Science of Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Cristiane Carboni', 'investigatorAffiliation': 'Federal University of Health Science of Porto Alegre'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-06-13', 'type': 'RELEASE'}, {'date': '2016-07-22', 'type': 'RESET'}, {'date': '2018-10-07', 'type': 'RELEASE'}, {'date': '2019-02-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Cristiane Carboni, Professor, Federal University of Health Science of Porto Alegre'}}}}