URINARY INCONTINENCE AND GERIATRIC SYNDROMES

NCT07813702 | Recruiting

• 1 other identifier: KBU-FTR-MU-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence (UI); Urinary Incontinence; Urinary Incontinence in Old Age; Urinary Incontinence in Geriatric Population; Geriatric Syndromes; Geriatric Syndrome; Frailty Syndrome; Frailty

Keywords

Urinary incontinence; Geriatric syndrome; Elderly individuals; Post-void residual urine volume; PVR; PHYSIOTHERAPY; Muscle strength; Physical parameters; Frailty; Sarcopenia; Physical performance; Falls

Outcome Measures

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.

  During the single study visit (cross-sectional baseline assessment)

Secondary Outcomes (7)

• Physical Performance Assessed Using the Short Physical Performance Battery

  During the single study visit (baseline assessment)

• Functional Mobility Assessed Using the Timed Up and Go Test

  During the single study visit (baseline assessment)

• Motor-Cognitive Mobility Assessed Using the Dual-Task Timed Up and Go Test

  During the single study visit (baseline assessment)

• Handgrip Strength Measured Using a Hand Dynamometer

  During the single study visit (baseline assessment)

• Isometric Quadriceps Muscle Strength Measured Using a Hand-Held Dynamometer

  During the single study visit (baseline assessment)

Other Outcomes (19)

• Sarcopenia Risk Assessed Using the SARC-F

  During the single study visit (baseline assessment)

• Appendicular Skeletal Muscle Mass Assessed Using Bioelectrical Impedance Analysis

  During the single study visit (baseline assessment)

• Calf Circumference

  During the single study visit (baseline assessment)

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MERT UYSAL: lead
• Karabuk Training and Research Hospital: collaborator
• Karabuk University: collaborator
• Abant Izzet Baysal University: collaborator

Study Sites (1)

Karabuk Training and Research Hospital

Karabük, Merkez, 78050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Eylem Tutun Yumin, Professor

  Abant Izzet Baysal University

  STUDY CHAIR

• Meral Sertel, Professor

  Uludag University

  STUDY DIRECTOR

• Fahrettin Samil Uysal, Assistant Professor

  Karabuk University

  STUDY DIRECTOR

• Mert Uysal, Lecturer

  Karabuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mert Uysal, Lecturer

CONTACT

0 (370) 418 8704; mertuysal@karabuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)