NCT07813702 - URINARY INCONTINENCE AND GERIATRIC SYNDROMES | Crick

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 65 years or older, * Presence of involuntary urinary leakage according to the International Continence Society definition, * At least one urinary leakage episode during the previous four weeks and an ICIQ-UI SF score of ≥1, * General health status adequate to tolerate the outpatient assessment protocol, * Ability to mobilize independently, * Ability to understand instructions in Turkish and complete the study questionnaires, * Willingness to participate and provision of written informed consent. Exclusion Criteria: * Acute urinary tract infection or acute lower urinary tract symptoms, * History of major pelvic or orthopedic surgery within the previous six months, * Acute musculoskeletal condition that may affect performance during the assessments, * Neurological disease causing severe mobility limitations, including Parkinson's disease or stroke, * Diabetic neuropathy, * 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, * Dementia or severe cognitive impairment, defined as Global Deterioration Scale stage 4 or higher, * Severe visual or hearing impairment that may prevent completion of the assessments, * Terminal illness or active malignancy, * Inability or unwillingness to provide informed consent, * Unwillingness or inability to complete the assessment protocol.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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.