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临床试验/NCT07813702
NCT07813702招募中不适用

THE IMPACT OF URINARY INCONTINENCE ON GERIATRIC SYNDROMES IN ELDERLY INDIVIDUALS

MERT UYSAL1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Frailty Level Assessed Using the FRAIL Scale

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Frailty Level Assessed Using the FRAIL Scale

时间窗: 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.

次要结局

  • 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))
  • Concern About Falling Assessed Using the Falls Efficacy Scale-International(During the single study visit (baseline assessment))
  • Sleep Quality Assessed Using the Pittsburgh Sleep Quality Index(During the single study visit, reflecting sleep during the previous month.)

研究者

发起方
MERT UYSAL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

MERT UYSAL

Lecturer

Karabuk University

研究点 (1)

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