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

NCT07055425 | Not Yet Recruiting

• 1 other identifier: MAR.UAD.0024
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lower Urinary Tract Symptom; Voiding Dysfunction; Male Urological Health; Renal Function; Benign Prostate Obstruction (BPO)

Keywords

Lower Urinary Tract Symptom; Benign Prostate Obstruction (BPO); Male Urological Health; Voiding Dysfunction; Aging Male

Outcome Measures

Primary Outcomes (2)

• Correlation Between Qmax/eGFR Ratio and Total IPSS Score

  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.

  At baseline

• Correlation Between Qmax/eGFR Ratio and IPSS Quality of Life Subscore

  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.

  At baseline

Secondary Outcomes (2)

• Factors Associated With Qmax/eGFR Ratio

  At baseline

• Association of Clinical Variables With Qmax/eGFR Ratio

  At baseline

Study Arms (1)

Men Over 40 With LUTS

Male patients aged 40 years or older presenting with lower urinary tract symptoms (LUTS), who undergo uroflowmetry and renal function testing, and complete the IPSS questionnaire. No interventions will be applied. This group will be prospectively observed for the association between Qmax/eGFR ratio and symptom severity.

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male outpatients aged 40 years or older who present with lower urinary tract symptoms (LUTS) to the urology clinic. Participants will be evaluated during routine clinical visits and must be capable of completing symptom questionnaires and undergoing non-invasive tests such as uroflowmetry and blood sampling. The study population is drawn from a single tertiary academic medical center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

günal özgür, Urology Specialist

CONTACT

+905357849485; gunalozgur91@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 8, 2025
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share