Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-03-25 @ 2:41 PM
Study NCT ID:
NCT02958904
Status:
COMPLETED
Last Update Posted:
2016-11-08
First Post:
2016-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D003863', 'term': 'Depression'}], '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'}, {'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'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2016-11-06', 'studyFirstSubmitQcDate': '2016-11-07', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'depressive symptoms', 'timeFrame': 'one day', 'description': 'Depressive symptoms assessed by Beck Depression Inventory (BDI)'}], '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 neurological 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', 'Erectile dysfunction', 'depression'], 'conditions': ['Spinal Cord Injuries', 'Male Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.', 'detailedDescription': 'Method: Observational study of 44 men with spinal cord injury, age above 18 years, injury time more than six months, sexually active and accompanied in Recife referral hospitals. The degree of neurological impairment was assessed using the revised version in 2011 ASIA Impairment Scale (AIS), depressive symptoms were detected by the Beck Depression Inventory, and the evaluation of sexual function was obtained through the Erectile Function of International Index (IIEF). Descriptive statistics and bivariate analysis to assess the association were applied, with 0,05 significance level.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 44 men, 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* 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': 'NCT02958904', 'briefTitle': 'Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'Association Between Depressive Symptoms and Sexual Dysfunction in Men With Traumatic Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'Depressive symptoms SCI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'using questionnaires', 'type': 'OTHER', 'description': 'using questionnaires International Index Erectile Function and Beck Depression Inventory.'}]}, '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'}}}}