Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02908867
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2016-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Strategies in Sexual Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D019529', 'term': 'Sexuality'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2016-09-18', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic Strategies', 'timeFrame': 'one day', 'description': 'Therapeutic Strategies assessed by semi structured form in public market'}], 'secondaryOutcomes': [{'measure': 'level of neurological lesion', 'timeFrame': 'one day', 'description': 'Level of neurological lesion assessed by ASIA Impairment Scale (AIS) according to the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury'}, {'measure': 'Degree of lesion', 'timeFrame': 'one day', 'description': 'Degree of neurological lesion assessed by ASIA Impairment Scale (AIS) according to the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury'}, {'measure': 'Male sexual dysfunction', 'timeFrame': 'one day', 'description': 'Male Sexual Dysfunction assessed by International Index of Erectile Function (IIEF)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sexuality', 'Spinal cord injuries', 'Complementary Therapies', 'Medicinal plants'], 'conditions': ['Male Sexual Dysfunction', 'Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'Objectives: To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions.', 'detailedDescription': 'Methods: This is a descriptive observational study involving 24 men with a mean age of 32.62 (CI 28.65 to 36.60), with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). The subjects underwent neurological evaluation in accordance with the guidelines of the International Standards for Neurological Examination and Functional classification of Spinal Cord Injury (ISNCSCI), the American Spinal Injury Association (ASIA), assessment of sexual function through the Erectile Function of International Index (IIEF) and answered a semi-structured form to identify therapeutic strategies used in sexual function. To collect information about medicinal plants, a search was made in the surroundings of public markets located in the Metropolitan Region of Recife (PE).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study involving 24 men with spinal cord injury, recruited in reference services in spinal cord injury Recife (PE). Aged between 18 and 60 years with a clinical diagnosis of traumatic spinal cord injury, injury time less than six months, heterosexual and sexually active. The study excluded patients who had erectile dysfunction attributed to endocrine or metabolic disease order, those who underwent surgery in the genital area, such as radical prostatectomy or penile implant and cognitive impairment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of traumatic spinal cord injury\n* injury time less than six months\n* heterosexual\n* sexually active\n\nExclusion Criteria:\n\n* patients who had erectile dysfunction attributed to endocrine or metabolic disease order\n* those who underwent surgery in the genital area, such as radical prostatectomy or penile implant\n* cognitive impairment'}, 'identificationModule': {'nctId': 'NCT02908867', 'briefTitle': 'Therapeutic Strategies in Sexual Function', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'Therapeutic Strategies in Sexual Function of Men With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'THERAPEUTIC STRATEGIES SCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Therapeutic strategies group', 'description': 'To know the main therapeutic strategies used by men with spinal cord injury in sexual dysfunctions, mainly medicinal plants.', 'interventionNames': ['Other: Therapeutic Strategies']}], 'interventions': [{'name': 'Therapeutic Strategies', 'type': 'OTHER', 'description': 'Using questionnaires (Erectile Function of International Index and American Impairment Scale) and search in public markets using semi structured form', 'armGroupLabels': ['Therapeutic strategies group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+5581', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Josepha Karinne de Oliveira Ferro', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'overallOfficials': [{'name': 'Josepha KO Ferro, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de Pernambuco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master degree', 'investigatorFullName': 'Josepha Karinne de Oliveira Ferro', 'investigatorAffiliation': 'Universidade Federal de Pernambuco'}}}}