URINARY INCONTINENCE AND GERIATRIC SYNDROMES

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorMERT UYSAL

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial population

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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Older Adults with Urinary Incontinence

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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)
4

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)

Other outcomes

1

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)
2

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)
3

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)
4

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)

Sponsors and contacts

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MERT UYSAL

Lead sponsor

Karabuk University

Sponsor institution

Karabuk Training and Research Hospital

Collaborator

Karabuk University

Collaborator

Abant Izzet Baysal University

Collaborator