Association Between Qmax/eGFR Ratio and LUTS Severity in Men Over 40

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.

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Key information

Conditions

Lower Urinary Tract Symptom Benign Prostate Obstruction (BPO) Lower Urinary Tract Symptoms Male Urological Health Pathological Conditions, Signs and Symptoms Renal Function Signs and Symptoms Urological Manifestations Voiding Dysfunction

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Correlation Between Qmax/eGFR Ratio and Total IPSS Score

Time frame: 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

Time frame: 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.

Secondary outcomes

Factors Associated With Qmax/eGFR Ratio

Time frame: At baseline

This outcome aims to identify clinical factors that may influence the Qmax/eGFR ratio in men over 40 with lower urinary tract symptoms. Variables to be analyzed may include age, prostate volume, voided volume, and average flow rate (Qave), among others. Multivariable analysis will be performed to explore independent associations.
Association of Clinical Variables With Qmax/eGFR Ratio

Time frame: At baseline

This analysis will identify clinical parameters independently associated with Qmax/eGFR ratio, including age, prostate volume, voided volume, and average flow rate (Qave). Multivariable regression models will be used to determine significant predictors.

Study contacts

Contact information is provided by the study sponsor or research team.

günal özgür, Urology Specialist

CONTACT

[email protected]

+905357849485

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Role of Qmax/eGFR Ratio in Assessing Symptom Severity and QoL in Men Over 40 With LUTS

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 8, 2025
Registry last updated: Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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