Karabuk Training and Research Hospital
Karabük, Merkez, 78050, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07813702
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.
Interested in participating?
Request Info65 year and older
All sexes
Observational
Karabük, Merkez, 78050, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During the single study visit (cross-sectional baseline assessment)
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 (baseline assessment)
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 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 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 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 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 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, reflecting sleep during the previous month.
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 (baseline assessment)
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 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 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 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 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)
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 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)
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)
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 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, reflecting 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
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 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 (baseline assessment)
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 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, reflecting the previous four weeks
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 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 (baseline assessment)
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)
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.
Contact information is provided by the study sponsor or research team.
MERT UYSAL
Other
THE IMPACT OF URINARY INCONTINENCE ON GERIATRIC SYNDROMES IN ELDERLY INDIVIDUALS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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