Lower Urinary Tract SymptomNCT07055425
Association Between Qmax/eGFR Ratio and LUTS Severity in Men Over 40
An observational study of Lower Urinary Tract Symptom and Voiding Dysfunction, run by Marmara University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptom, Voiding Dysfunction, Male Urological Health
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 May 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Role of Qmax/eGFR Ratio in Assessing Symptom Severity and QoL in Men Over 40 With LUTS
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline
Secondary outcomes (2)
Factors Associated With Qmax/eGFR Ratio
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.
Measured: At baseline
Association of Clinical Variables With Qmax/eGFR Ratio
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055425
- Sponsor's protocol ID
- MAR.UAD.0024
- Status last verified
- Aug 2025
- First submitted
- 21 Jun 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to the observational design, single-center setting, and the absence of genomic or identifying information. However, anonymized data may be made available upon reasonable scientific request and after appropriate ethical and institutional approvals.