An observational study in Urinary Incontinence (UI), Urinary Incontinence and Urinary Incontinence in Old Age, sponsored by MERT UYSAL. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by MERT UYSAL · 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.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 215 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →This is the only study on the registry with MERT UYSAL as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: During the single study visit (cross-sectional baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit, reflecting sleep during the previous month.
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.
Time frame: During the single study visit (baseline assessment)
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/m²). Values below 7.0 kg/m² in men and below 5.5 kg/m² in women will be considered indicative of low muscle mass.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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).
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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/s will be classified as slow gait speed.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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/no).
Time frame: During the single study visit, reflecting the previous 12 months
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.
Time frame: During the single study visit, reflecting the previous 12 months
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/no).
Time frame: During the single study visit, reflecting the previous 12 months
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit, reflecting the previous four weeks
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.
Time frame: During the single study visit, reflecting the previous four weeks
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.
Time frame: During the single study visit (baseline assessment)
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.
Time frame: During the single study visit (baseline assessment)
Plan to share: No — Individual participant data will not be shared because the informed consent and ethics approval do not include external sharing or secondary use of individual-level health data. Only aggregated study results will be disseminated.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Nov 2026, 7 months after the start.
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