The Role of Qmax/eGFR Ratio in Assessing Symptom Severity and QoL in Men Over 40 With LUTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Correlation Between Qmax/eGFR Ratio and Total IPSS Score
研究概览
简要总结
This study will look at how well a measure called the Qmax/eGFR ratio is related to the severity of urination problems in men over the age of 40. Qmax is a test that shows how fast a person can urinate, and eGFR is a number that reflects kidney function. Men who have urinary symptoms will be asked to do a urine flow test, a blood test, and fill out a questionnaire about their symptoms and quality of life. We will study if there is a link between the Qmax/eGFR ratio and how severe their symptoms are. The results may help doctors better understand how kidney and urinary function are related in men with these problems.
详细描述
This prospective observational study aims to explore the clinical relevance of the Qmax/eGFR ratio in men over 40 years of age presenting with lower urinary tract symptoms (LUTS). Qmax, derived from uroflowmetry, reflects bladder emptying function, while eGFR represents renal filtration capacity. While both parameters are routinely measured in clinical practice, their combined predictive or associative value in LUTS severity has not been well defined.
Participants will undergo standard non-invasive assessments including uroflowmetry, serum creatinine testing (for eGFR calculation), and will complete the International Prostate Symptom Score (IPSS) questionnaire. The IPSS includes both total symptom score and quality of life (QoL) component. The primary objective is to evaluate the correlation between the Qmax/eGFR ratio and IPSS total score. Secondary objectives include the relationship between Qmax/eGFR and QoL scores, as well as analysis based on prostate volume categories.
This study seeks to identify whether the Qmax/eGFR ratio may serve as a composite marker reflecting both voiding efficiency and renal function in the clinical assessment of LUTS, potentially supporting more individualized decision-making in urological practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 40 years or older presenting with lower urinary tract symptoms (LUTS)
- •Able to provide informed consent
- •Willing and able to undergo uroflowmetry and blood testing
- •Able to complete the IPSS questionnaire, including the QoL item
- •Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m²
排除标准
- •History of urological surgery (e.g., prostatectomy, bladder surgery)
- •Diagnosed or suspected prostate cancer
- •Active urinary tract infection (based on clinical symptoms or urinalysis)
- •Neurological conditions affecting bladder function (e.g., Parkinson's disease, spinal cord injury)
- •Presence of an indwelling urinary catheter at enrollment
- •eGFR < 30 mL/min/1.73m²
- •Inability to perform uroflowmetry or complete clinical evaluations
结局指标
主要结局
Correlation Between Qmax/eGFR Ratio and Total IPSS Score
时间窗: At baseline
This outcome assesses the statistical correlation between the Qmax/eGFR ratio and the total International Prostate Symptom Score (IPSS). Pearson or Spearman correlation analysis will be used to evaluate the relationship between the ratio and LUTS severity.
Correlation Between Qmax/eGFR Ratio and IPSS Quality of Life Subscore
时间窗: At baseline
This outcome evaluates the correlation between the Qmax/eGFR ratio and the IPSS Quality of Life (QoL) subscore, aiming to assess the association between voiding/renal parameters and patient-perceived well-being.
次要结局
- Factors Associated With Qmax/eGFR Ratio(At baseline)
- Association of Clinical Variables With Qmax/eGFR Ratio(At baseline)
研究者
Tarik Emre Sener
Assoc. Prof.
Marmara University