Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-28 @ 3:33 AM
Study NCT ID:
NCT05964803
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2023-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lower Urinary Tract Symptoms in Males Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006679', 'term': 'HIV Seropositivity'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2023-07-09', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire 1', 'timeFrame': 'Day 1', 'description': 'International Consultation on Incontinence Questionnaire'}, {'measure': 'Questionnaire 2', 'timeFrame': 'Day 1', 'description': 'Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)'}, {'measure': 'Questionnaire 3', 'timeFrame': 'Day 1', 'description': 'ICIQ-Short Form (ICIQ-SF)'}, {'measure': 'Questionnaire 4', 'timeFrame': 'Day 1', 'description': 'International Prostate Symptom Score (IPSS)'}, {'measure': 'Questionnaire 5', 'timeFrame': 'Day 1', 'description': "King's Healthcare Questionnaire (KHQ)"}, {'measure': 'Questionnaire 6', 'timeFrame': 'Day 1', 'description': '8-item Overactive Bladder Questionnaire (OAB-V8)'}, {'measure': 'Questionnaire 7', 'timeFrame': 'Day 1', 'description': 'Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Seropositivity', 'Lower Urinary Tract Symptoms']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to learn whether the frequency of lower urinary tract symptoms differ between the males with seronegativity for HIV and males living with HIV.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Infectious Diseases Clinic (100 living with HIV, 100 HIV-negative males) will be directed to Urology clinic. The same questionnaires will be given and scores will be compared.', 'genderDescription': 'Males above 18 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above 18 years old\n\nExclusion Criteria:\n\n* Non-Turkish speakers\n* Previous surgeries or medications for lower urinary tract symptoms'}, 'identificationModule': {'nctId': 'NCT05964803', 'briefTitle': 'Lower Urinary Tract Symptoms in Males Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'Koç University'}, 'officialTitle': 'Males Living With HIV and LUTS: A Case-control Study.', 'orgStudyIdInfo': {'id': 'KocUrol5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Males living with HIV', 'description': 'Males living with HIV and followed by infectious diseases clinic will be directed to Urology department.', 'interventionNames': ['Diagnostic Test: Questionnaires']}, {'label': 'HIV-negative controls', 'description': 'Males admitted to Infectious Diseases clinic and documented to be HIV-negative.', 'interventionNames': ['Diagnostic Test: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'DIAGNOSTIC_TEST', 'description': "MLWH and control groups were asked to complete the following questionnaires: International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), ICIQ-Short Form (ICIQ-SF), International Prostate Symptom Score (IPSS), King's Healthcare Questionnaire (KHQ), 8-item Overactive Bladder Questionnaire (OAB-V8), Urogenital Distress Inventory 6 and 7 (UDI 6 and UDI 7).", 'armGroupLabels': ['HIV-negative controls', 'Males living with HIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Koc University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koç University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ersin Köseoglu', 'investigatorAffiliation': 'Koç University'}}}}