Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT04764903
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association of Baseline Characteristics of Male Patients Presented With LUTS and Long Term Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], 'ancestors': [{'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2021-02-16', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall prevalence of adverse cardiovascular events (MACE) in male patients presented with lower urinary tract symptoms (LUTS)', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Major adverse cardiovascular events such as myocardial infraction, ischemic heart disease, heart failure, coronary angioplasty etc. in male patients with LUTS. It is assessed by medical record'}, {'measure': 'The overall prevalence of diabetes in male patients presented with lower urinary tract symptoms (LUTS)', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'It is assessed by medical record'}, {'measure': 'The overall prevalence of dyslipidaemia in male patients presented with lower urinary tract symptoms (LUTS)', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'It is assessed by medical record'}], 'secondaryOutcomes': [{'measure': 'Correlation between nocturia and Central arterial stiffness (CAS)', 'timeFrame': 'Baseline', 'description': 'Nocturia is assessed by International Prostate Symptom Score Question 7, high value means worser nocturia; CAS is assessed by brachial-ankle PWV (baPWV), the value \\>1800cm/sec is highly associated with development of MACE'}, {'measure': 'Incidence of acute retention of urine', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'It is assessed by medical record'}, {'measure': 'Incidence of requirement of surgical intervention', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'It is assessed by medical record'}, {'measure': 'Overall mortality', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'It is assessed by medical record'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Urinary Tract Symptoms']}, 'referencesModule': {'references': [{'pmid': '18057428', 'type': 'BACKGROUND', 'citation': 'Ng CF, Wong A, Li ML, Chan SY, Mak SK, Wong WS. The prevalence of cardiovascular risk factors in male patients who have lower urinary tract symptoms. Hong Kong Med J. 2007 Dec;13(6):421-6.'}, {'pmid': '30083830', 'type': 'BACKGROUND', 'citation': 'Yee CH, Yip JSY, Cheng NMY, Kwan CH, Li KM, Teoh JYC, Chiu PKF, Wong JH, Chan ESY, Chan CK, Hou SSM, Ng CF. The cardiovascular risk factors in men with lower urinary tract symptoms. World J Urol. 2019 Apr;37(4):727-733. doi: 10.1007/s00345-018-2432-2. Epub 2018 Aug 6.'}, {'pmid': '30648670', 'type': 'BACKGROUND', 'citation': 'Teoh JY, Chan CK, Wang MH, Leung CH, Chan ES, Chiu PK, Yee CH, Wong HM, Hou SS, Ng CF. Transurethral resection of prostate for acute urinary retention is linked to shorter survival in younger men. Asian J Androl. 2019 Sep-Oct;21(5):468-472. doi: 10.4103/aja.aja_101_18.'}, {'pmid': '29767479', 'type': 'BACKGROUND', 'citation': 'Everaert K, Anderson P, Wood R, Andersson FL, Holm-Larsen T. Nocturia is more bothersome than daytime LUTS: Results from an Observational, Real-life Practice Database including 8659 European and American LUTS patients. Int J Clin Pract. 2018 Jun;72(6):e13091. doi: 10.1111/ijcp.13091. Epub 2018 May 16.'}]}, 'descriptionModule': {'briefSummary': 'Non-neurogenic male lower urinary tract symptom (LUTS) is one of the most common symptom presented in urological clinic. Male LUTS could be a result of a combination of many different conditions, including benign prostate hypertrophy, overactive bladder, diabetes, noctural polyuria, sleep apnoea etc. Also male LUTS has shown to have close relationship with metabolic and cardiovascular conditions. Because of the increasing evidences to suggest a close relationship of cardiovascular condition and metabolic problems and male LUTS, this is a study to retrospective review of the patients assessed in this urology clinic and have a more in-depth assessment of the relationship of the baseline characteristics of these medical conditions with the presenting symptoms, as well as the long term urological and overall clinical outcomes of these patients.', 'detailedDescription': 'This is a retrospective study.Male patients who presented with lower urinary tract symptom to our centre and assessed in the urology clinic from 2005 to 2019 would be enrolled to the study. This study will be conducted by observation; that is, data will be captured from medical records and central medical system (CMS), but patients will not be contacted. All the demographic and medical background, as well as investigations performed during the assessment including uroflowmetry, post-voiding residual, questionnaires, blood pressure, pulse, vascular assessment and blood result will be collected. Follow-up data including usage of medication, clinical outcomes (such as development of urinary retention, cardiovascular events, need of surgical intervention, mortality etc.) will be captured from the medical records.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '35 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients who presented with lower urinary tract symptom to our centre and assessed in the nurse-led pre-assessment clinic', 'genderDescription': 'Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged between 35 and 90 years old with LUTS/nocturia and received assessment at urology centre.\n\nExclusion Criteria:\n\n* Men having history of prostatic surgery, prostate cancer, active urinary tract infection, aortic aneurysm, marked cardiac arrhythmia and severe peripheral vascular disease'}, 'identificationModule': {'nctId': 'NCT04764903', 'briefTitle': 'The Association of Baseline Characteristics of Male Patients Presented With LUTS and Long Term Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Retrospective Review of the Association of Baseline Characteristics of Male Patients Presented With Lower Urinary Tract and Long Term Clinical Outcomes', 'orgStudyIdInfo': {'id': 'CRE-2019.400'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LUTS/Nocturia', 'description': 'Patients with LUTS / Nocturia', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There is no intervention in this study', 'armGroupLabels': ['LUTS/Nocturia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Chi Fai NG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chi Fai NG', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}