[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655479":3},{"organization":4,"outcomesModule":7,"designInfo":97,"detailedDescription":98,"studyPopulation":101,"armGroups":102,"interventions":98,"overallOfficials":106,"centralContacts":120,"locations":125,"responsibleParty":139,"collaborators":143,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":98,"eligibilityCriteria":153,"healthyVolunteers":149,"sex":154,"minAge":155,"maxAge":98,"enrollmentInfo":156,"targetDuration":98,"studyType":159,"phases":98,"briefSummary":160,"conditions":161,"keywords":170,"overallStatus":128,"whyStopped":98,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Karabuk University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Frailty Level Assessed Using the FRAIL Scale","The primary outcome is frailty level, assessed using the five-item FRAIL Scale. The total score ranges from 0 to 5, with higher scores indicating greater frailty. Participants will be classified as robust (0 points), prefrail (1-2 points), or frail (≥3 points). The primary exposures are urinary incontinence severity, assessed using the ICIQ-UI SF total score (range: 0-21), and post-void residual urine volume, recorded in milliliters as the mean of two consecutive bladder scanner measurements performed within 10 minutes after voiding. The independent associations of ICIQ-UI SF score and post-void residual urine volume with frailty level will be examined in the same multivariable regression model after adjustment for prespecified covariates.","During the single study visit (cross-sectional baseline assessment)",[14,18,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Physical Performance Assessed Using the Short Physical Performance Battery","Physical performance will be assessed using the Short Physical Performance Battery (SPPB), comprising standing balance, usual-paced walking, and five-repetition chair-rise tests. Each component is scored from 0 to 4, resulting in a total score ranging from 0 to 12. Higher scores indicate better physical performance. A total score of ≤8 will be considered indicative of low physical performance.","During the single study visit (baseline assessment)",{"measure":19,"description":20,"timeFrame":17},"Functional Mobility Assessed Using the Timed Up and Go Test","Functional mobility will be assessed using the Timed Up and Go Test (TUG). Participants will stand up from a chair, walk three meters, turn, walk back to the chair, and sit down. Completion time will be recorded in seconds, with longer times indicating poorer functional mobility.",{"measure":22,"description":23,"timeFrame":17},"Motor-Cognitive Mobility Assessed Using the Dual-Task Timed Up and Go Test","Motor-cognitive mobility will be assessed using the Dual-Task Timed Up and Go Test (DT-TUG). Participants will complete the TUG while simultaneously performing serial subtraction by threes from 100. Completion time will be recorded in seconds, with longer times indicating poorer motor-cognitive mobility performance.",{"measure":25,"description":26,"timeFrame":17},"Handgrip Strength Measured Using a Hand Dynamometer","Handgrip strength will be measured in the dominant hand using a BASELINE hand dynamometer. Three trials will be performed, and the highest value, recorded in kilograms, will be used in the analysis. Values below 27 kg in men and below 16 kg in women will be classified as low muscle strength.",{"measure":28,"description":29,"timeFrame":17},"Isometric Quadriceps Muscle Strength Measured Using a Hand-Held Dynamometer","Isometric quadriceps muscle strength will be measured using a hand-held dynamometer (BASELINE) under a standardized testing protocol. Participants will perform two maximal voluntary isometric contractions with standardized verbal encouragement. The highest force value obtained from the two trials will be used in the analysis, with higher values indicating greater quadriceps muscle strength.",{"measure":31,"description":32,"timeFrame":17},"Concern About Falling Assessed Using the Falls Efficacy Scale-International","Concern about falling will be assessed using the 16-item Falls Efficacy Scale-International (FES-I). Each item is scored from 1 to 4, producing a total score ranging from 16 to 64. Higher scores indicate greater concern about falling. Scores of 16-19, 20-27, and 28-64 will be classified as low, moderate, and high concern about falling, respectively.",{"measure":34,"description":35,"timeFrame":36},"Sleep Quality Assessed Using the Pittsburgh Sleep Quality Index","Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 will be considered indicative of poor sleep quality.","During the single study visit, reflecting sleep during the previous month.",[38,41,44,47,50,53,56,59,62,65,68,72,75,78,81,84,88,91,94],{"measure":39,"description":40,"timeFrame":17},"Sarcopenia Risk Assessed Using the SARC-F","Sarcopenia risk will be assessed using the five-item SARC-F questionnaire. Each item is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate greater sarcopenia risk, and a total score of ≥4 will be considered indicative of sarcopenia risk.",{"measure":42,"description":43,"timeFrame":17},"Appendicular Skeletal Muscle Mass Assessed Using Bioelectrical Impedance Analysis","Appendicular skeletal muscle mass will be measured using a Tanita multi-frequency segmental body composition analyzer. Appendicular skeletal muscle mass will be recorded in kilograms, and the appendicular skeletal muscle mass index will be calculated as appendicular skeletal muscle mass divided by height squared (kg\u002Fm²). Values below 7.0 kg\u002Fm² in men and below 5.5 kg\u002Fm² in women will be considered indicative of low muscle mass.",{"measure":45,"description":46,"timeFrame":17},"Calf Circumference","Calf circumference will be measured using a non-elastic tape at the widest part of both calves. The highest measurement will be recorded in centimeters. Values below 34 cm in men and below 33 cm in women will be classified as low calf circumference.",{"measure":48,"description":49,"timeFrame":17},"Nutritional Status Assessed Using the Mini Nutritional Assessment-Short Form","Nutritional status will be assessed using the six-item Mini Nutritional Assessment-Short Form (MNA-SF). The total score ranges from 0 to 14. Participants will be classified as having normal nutritional status (12-14 points), being at risk of malnutrition (8-11 points), or having malnutrition (0-7 points).",{"measure":51,"description":52,"timeFrame":17},"Depressive Symptoms Assessed Using the Geriatric Depression Scale-5","Depressive symptoms will be assessed using the five-item Geriatric Depression Scale (GDS-5). The total score ranges from 0 to 5, with higher scores indicating more depressive symptoms. Two or more depressive responses will be considered indicative of clinically relevant depressive symptoms.",{"measure":54,"description":55,"timeFrame":17},"Cognitive Function Assessed Using the Montreal Cognitive Assessment","Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better cognitive performance and lower scores indicating poorer cognitive function.",{"measure":57,"description":58,"timeFrame":17},"Static Balance Assessed Using the Single-Leg Stance Test","Static balance will be assessed using the Single-Leg Stance Test. Participants will stand unsupported on one leg, and the duration for which balance can be maintained will be recorded in seconds. The best result will be used in the analysis. Inability to maintain the position for at least five seconds will be reported as a clinical indicator of increased fall risk.",{"measure":60,"description":61,"timeFrame":17},"Short Physical Performance Battery Component Scores","The balance, four-meter walking, and five-repetition chair-rise components of the SPPB will be evaluated separately. Each component is scored from 0 to 4, with higher scores indicating better performance.",{"measure":63,"description":64,"timeFrame":17},"Four-Meter Usual Gait Speed","Participants will walk a marked four-meter course at their usual walking speed. Completion time will be recorded in seconds, and gait speed will be calculated in meters per second by dividing four meters by the completion time. A gait speed of ≤0.8 m\u002Fs will be classified as slow gait speed.",{"measure":66,"description":67,"timeFrame":17},"Cognitive-Task Performance During the Dual-Task Timed Up and Go Test","Cognitive-task performance during the DT-TUG will be evaluated by recording the number of errors made during serial subtraction by threes from 100. Whether the participant stops walking while performing the cognitive task and the number of walking stops will also be recorded.",{"measure":69,"description":70,"timeFrame":71},"Occurrence of Falls During the Previous 12 Months","Participants will be asked whether they experienced at least one fall during the previous 12 months. Fall occurrence will be recorded as a binary variable (yes\u002Fno).","During the single study visit, reflecting the previous 12 months",{"measure":73,"description":74,"timeFrame":71},"Number of Falls During the Previous 12 Months","The self-reported total number of falls experienced by each participant during the previous 12 months will be recorded as a count variable.",{"measure":76,"description":77,"timeFrame":71},"Recurrent Falls During the Previous 12 Months","Recurrent falling will be defined as two or more self-reported falls during the previous 12 months and will be recorded as a binary variable (yes\u002Fno).",{"measure":79,"description":80,"timeFrame":17},"Urinary Symptom-Related Quality of Life Assessed Using the ICIQ-LUTSqol","The impact of urinary symptoms on quality of life will be assessed using the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). The total score ranges from 19 to 76, with higher scores indicating a greater negative impact of urinary symptoms on quality of life.",{"measure":82,"description":83,"timeFrame":17},"Urinary Incontinence Subtype Assessed Using the 3 Incontinence Questions","Urinary incontinence subtype will be determined using the 3 Incontinence Questions (3IQ). Based on the circumstances in which urinary leakage occurs most frequently, participants will be classified as having stress, urgency, mixed, or other urinary incontinence.",{"measure":85,"description":86,"timeFrame":87},"Nocturia Frequency","Nocturia will be assessed as the self-reported number of times per night that the participant wakes from the main sleep period to urinate. The average number of nocturia episodes per night during the previous four weeks will be recorded.","During the single study visit, reflecting the previous four weeks",{"measure":89,"description":90,"timeFrame":87},"Urinary Urgency","Urinary urgency will be assessed as the presence of a sudden and compelling desire to urinate that is difficult to defer. Urgency presence and frequency during the previous four weeks will be recorded using brief symptom questions.",{"measure":92,"description":93,"timeFrame":17},"Health-Related Quality of Life Assessed Using the EQ-5D Index","Health-related quality of life will be assessed using the EQ-5D, which evaluates mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Responses will be converted into an EQ-5D index value, with higher index values indicating better health-related quality of life.",{"measure":95,"description":96,"timeFrame":17},"Self-Rated Health Assessed Using the EQ Visual Analogue Scale","Participants will rate their current overall health using the EQ Visual Analogue Scale. Scores range from 0, representing the worst imaginable health state, to 100, representing the best imaginable health state. Higher scores indicate better self-rated health.",{"allocation":98,"interventionModel":98,"interventionModelDescription":98,"primaryPurpose":98,"observationalModel":99,"timePerspective":100,"maskingInfo":98},null,"CASE_ONLY","CROSS_SECTIONAL","The study population will consist of women and men aged 65 years or older presenting to the Urology Outpatient Clinic of Karabuk Training and Research Hospital with urinary incontinence. Individuals who meet the eligibility criteria, are able to mobilize independently, and provide written informed consent will be enrolled consecutively during the study period. All participants will have experienced at least one urinary leakage episode during the previous four weeks and will have an ICIQ-UI SF score of ≥1. No healthy control group will be included.",[103],{"label":104,"type":98,"description":105,"interventionNames":98},"Older Adults with Urinary Incontinence","Adults aged 65 years or older with urinary incontinence, defined as at least one episode of urinary leakage during the previous four weeks and an ICIQ-UI SF score of ≥1, will be included. Participants will undergo a single-visit observational assessment of urinary incontinence severity and type, post-void residual urine volume, frailty, sarcopenia risk, cognitive function, physical performance, balance, falls, fear of falling, sleep, nutritional status, depressive symptoms, and quality of life. No intervention will be administered.",[107,111,115,117],{"name":108,"affiliation":109,"role":110},"Eylem Tutun Yumin, Professor","Abant Izzet Baysal University","STUDY_CHAIR",{"name":112,"affiliation":113,"role":114},"Meral Sertel, Professor","Uludag University","STUDY_DIRECTOR",{"name":116,"affiliation":5,"role":114},"Fahrettin Samil Uysal, Assistant Professor",{"name":118,"affiliation":5,"role":119},"Mert Uysal, Lecturer","PRINCIPAL_INVESTIGATOR",[121],{"name":118,"role":122,"phone":123,"phoneExt":98,"email":124},"CONTACT","0 (370) 418 8704","mertuysal@karabuk.edu.tr",[126],{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":132,"countryCode":98,"cosmosGeoPoint":133,"geoPoint":138,"contacts":98},"Karabuk Training and Research Hospital","RECRUITING","Karabük","Merkez","78050","Turkey (Türkiye)",{"type":134,"coordinates":135},"Point",[136,137],32.62768,41.20488,{"lat":137,"lon":136},{"type":140,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":98,"oldOrganization":98},"SPONSOR_INVESTIGATOR","MERT UYSAL","Lecturer",[144,145,146],{"name":127,"class":6},{"name":5,"class":6},{"name":109,"class":6},"100655479","urinary-incontinence-and-geriatric-syndromes-100655479",false,"NCT07813702","URINARY INCONTINENCE AND GERIATRIC SYNDROMES","THE IMPACT OF URINARY INCONTINENCE ON GERIATRIC SYNDROMES IN ELDERLY INDIVIDUALS","Inclusion Criteria:\n\n* Age 65 years or older,\n* Presence of involuntary urinary leakage according to the International Continence Society definition,\n* At least one urinary leakage episode during the previous four weeks and an ICIQ-UI SF score of ≥1,\n* General health status adequate to tolerate the outpatient assessment protocol,\n* Ability to mobilize independently,\n* Ability to understand instructions in Turkish and complete the study questionnaires,\n* Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n* Acute urinary tract infection or acute lower urinary tract symptoms,\n* History of major pelvic or orthopedic surgery within the previous six months,\n* Acute musculoskeletal condition that may affect performance during the assessments,\n* Neurological disease causing severe mobility limitations, including Parkinson's disease or stroke,\n* Diabetic neuropathy,\n* Severe cardiopulmonary disease, including New York Heart Association class III-IV heart failure or forced expiratory volume in one second below 30% of the predicted value,\n* Dementia or severe cognitive impairment, defined as Global Deterioration Scale stage 4 or higher,\n* Severe visual or hearing impairment that may prevent completion of the assessments,\n* Terminal illness or active malignancy,\n* Inability or unwillingness to provide informed consent,\n* Unwillingness or inability to complete the assessment protocol.","ALL","65 Years",{"count":157,"type":158},120,"ESTIMATED","OBSERVATIONAL","The aim of this cross-sectional observational study is to examine the independent associations of urinary incontinence severity and post-void residual urine volume with frailty and other geriatric outcomes in older adults presenting to a urology outpatient clinic with urinary incontinence.",[162,163,164,165,166,167,168,169],"Urinary Incontinence (UI)","Urinary Incontinence","Urinary Incontinence in Old Age","Urinary Incontinence in Geriatric Population","Geriatric Syndromes","Geriatric Syndrome","Frailty Syndrome","Frailty",[171,172,173,174,175,176,177,178,169,179,180,181],"Urinary incontinence","Geriatric syndrome","Elderly individuals","Post-void residual urine volume","PVR","PHYSIOTHERAPY","Muscle strength","Physical parameters","Sarcopenia","Physical performance","Falls","2026-09-04",{"date":184,"type":185},"2026-09-10","ACTUAL",{"date":187,"type":185},"2026-04-08",{"date":189,"type":158},"2026-11",{"name":141,"class":6},1]