Nctid:
NCT06222515
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014549", "term"=>"Urinary Incontinence"}, {"id"=>"D000014550", "term"=>"Urinary Incontinence, Stress"}, {"id"=>"D000053202", "term"=>"Urinary Incontinence, Urge"}, {"id"=>"D000059411", "term"=>"Lower Urinary Tract Symptoms"}, {"id"=>"D000053158", "term"=>"Nocturia"}], "ancestors"=>[{"id"=>"D000014555", "term"=>"Urination Disorders"}, {"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000020924", "term"=>"Urological Manifestations"}], "browseLeaves"=>[{"id"=>"M17299", "name"=>"Urinary Incontinence", "asFound"=>"Urinary Incontinence", "relevance"=>"HIGH"}, {"id"=>"M7936", "name"=>"Enuresis", "relevance"=>"LOW"}, {"id"=>"M17300", "name"=>"Urinary Incontinence, Stress", "asFound"=>"Stress Urinary Incontinence", "relevance"=>"HIGH"}, {"id"=>"M27168", "name"=>"Urinary Incontinence, Urge", "asFound"=>"Urinary Urge Incontinence", "relevance"=>"HIGH"}, {"id"=>"M29464", "name"=>"Lower Urinary Tract Symptoms", "asFound"=>"Lower Urinary Tract Symptoms", "relevance"=>"HIGH"}, {"id"=>"M27158", "name"=>"Nocturia", "asFound"=>"Urinary Frequency More Than Once at Night", "relevance"=>"HIGH"}, {"id"=>"M17305", "name"=>"Urination Disorders", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M22659", "name"=>"Urological Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>4200}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2009-07-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-05", "completionDateStruct"=>{"date"=>"2021-12-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-02-01", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-05", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2021-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Female lower urinary tract symptom classification", "timeFrame"=>"3 days", "description"=>"Classification of female lower urinary tract symptoms based on bladder diary, , including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F) and the combination of diagnoses."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Storage", "Lower urinary tract symptom", "Female", "Bladder diary"], "conditions"=>["Urinary Urge Incontinence", "Urinary Frequency More Than Once at Night", "Stress Urinary Incontinence"]}, "referencesModule"=>{"references"=>[{"pmid"=>"19941278", "type"=>"RESULT", "citation"=>"Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798."}, {"pmid"=>"19302497", "type"=>"RESULT", "citation"=>"Coyne KS, Wein AJ, Tubaro A, Sexton CC, Thompson CL, Kopp ZS, Aiyer LP. The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:4-11. doi: 10.1111/j.1464-410X.2009.08371.x."}, {"pmid"=>"29398096", "type"=>"RESULT", "citation"=>"Hsiao SM, Lin HH. Medical treatment of female overactive bladder syndrome and treatment-related effects. J Formos Med Assoc. 2018 Oct;117(10):871-878. doi: 10.1016/j.jfma.2018.01.011. Epub 2018 Feb 15."}, {"pmid"=>"25022469", "type"=>"RESULT", "citation"=>"Hsiao SM, Su TC, Chen CH, Chang TC, Lin HH. Autonomic dysfunction and arterial stiffness in female overactive bladder patients and antimuscarinics related effects. Maturitas. 2014 Sep;79(1):65-9. doi: 10.1016/j.maturitas.2014.06.001. Epub 2014 Jun 20."}, {"pmid"=>"25238744", "type"=>"RESULT", "citation"=>"Hsiao SM, Liao SC, Chen CH, Chang TC, Lin HH. Psychometric assessment of female overactive bladder syndrome and antimuscarinics-related effects. Maturitas. 2014 Dec;79(4):428-34. doi: 10.1016/j.maturitas.2014.08.009. Epub 2014 Sep 3."}]}, "descriptionModule"=>{"briefSummary"=>"Storage urinary symptoms are the most complained of lower urinary tract symptoms (LUTS) and need further classification. This original study aims to derive a novel classification algorism for female storage LUTS according to a 3-day bladder diary (BD). Further feasibility of the application was also evaluated.", "detailedDescription"=>"Between July 2009 and December 2021, all women with storage lower urinary tract symptoms (LUTS) who visited the urogynecological department of a medical center were included. Women without complete data of a 3-day bladder diary (BD) were excluded from this study. The women were allocated into 12 groups according to the study flowchart based on their LUTS, including urinary urgency, stress urinary incontinence, urgency urinary incontinence, nocturia and frequency. MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was applied, and a P-value of less than 0.05 was considered as statistically significant. Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons with p \\< 0.05 after ANOVA."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"20 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Between July 2009 and December 2021, all women with storage LUTS who visited the urogynecological department of a medical center were included. Women without complete data of a BD were excluded from this study. The women were allocated into 12 groups according to the study flowchart based on their LUTS, including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F). MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was applied, and a P-value of less than 0.05 was considered as statistically significant. Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons with p \\< 0.05 after ANOVA.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Women more than 20-years-old\n* With storage lower urinary tract symptoms\n* Finished a 3-day bladder diary\n\nExclusion Criteria:\n\n* No lower urinary tract symptoms\n* Pregnant\n* Incomplete data of bladder diary"}, "identificationModule"=>{"nctId"=>"NCT06222515", "briefTitle"=>"Bladder Diary for Female Storage LUTS", "organization"=>{"class"=>"OTHER", "fullName"=>"National Taiwan University Hospital"}, "officialTitle"=>"Novel Classification Algorism Derived From 3-day Bladder Diary for Female Storage Lower Urinary Tract Symptoms and Correlations of Clinical and Urodynamic Findings", "orgStudyIdInfo"=>{"id"=>"202303058RINC"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Women with storage lower urinary tract symptom", "description"=>"The women with lower urinary tract symptoms, including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F).", "interventionNames"=>["Diagnostic Test: Bladder diary"]}], "interventions"=>[{"name"=>"Bladder diary", "type"=>"DIAGNOSTIC_TEST", "description"=>"3-day bladder diary record including fluid intake, urine amount, urgency and incontinence.", "armGroupLabels"=>["Women with storage lower urinary tract symptom"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100", "city"=>"Taipei", "country"=>"Taiwan", "facility"=>"Pei-chi Wu", "geoPoint"=>{"lat"=>25.04776, "lon"=>121.53185}}], "overallOfficials"=>[{"name"=>"Pei-chi Wu, MD.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Taiwan University Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"The data will be shared under reasonable request."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Taiwan University Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
