Clinical trial NCT07016776: Uroflowmetry Curve Types and IPSS in Men With LUTS
Official title: Evaluation of the Association Between Uroflowmetry Curve Patterns and IPSS Domains in Men With Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lower Urinary Tract Symptoms (LUTS)
Benign Prostatic Hyperplasia (BPH)
Voiding Dysfunction
Keywords: International Prostate Symptom Score (IPSS)
Uroflowmetry
Flow curve pattern
Male urinary symptoms
Prospective observational study
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 250
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male outpatients aged 40 years and older with LUTS who presented to the urology department of a tertiary academic center.

Brief summary: This prospective observational study aims to evaluate the relationship between different uroflowmetry curve types and International Prostate Symptom Score (IPSS) domains in men presenting with lower urinary tract symptoms (LUTS). Participants will undergo routine clinical evaluations including uroflowmetry, laboratory assessments, and completion of the IPSS questionnaire.

Each participant will be classified into one of five predefined uroflowmetry curve types (normal/bell-shaped, plateau, staccato, intermittent, or tower-like). The IPSS will be analyzed both as a total score and as two subdomains: storage and voiding symptoms. Additional data such as age, comorbidities, medication use, prostate volume, eGFR, and QoL score will also be recorded to assess potential correlations and predictive factors for symptom severity.

The goal of this study is to better understand how objective urodynamic findings correlate with patient-reported symptoms and to inform clinical decision-making in men with LUTS.

Detailed description: This is a single-center, prospective, cross-sectional observational study conducted at Marmara University, Faculty of Medicine, Department of Urology. The study includes male patients aged 40 years and older presenting with lower urinary tract symptoms (LUTS) who are capable of completing the International Prostate Symptom Score (IPSS) questionnaire and undergoing uroflowmetry.

The primary objective is to evaluate the association between uroflowmetry curve types and IPSS scores, particularly focusing on the IPSS storage domain (questions 2, 4, 7), voiding domain (questions 1, 3, 5, 6), and the total score. Patients will be classified according to five uroflowmetry curve patterns: 1) normal (bell-shaped), 2) plateau, 3) staccato, 4) interrupted/intermittent, and 5) tower-like.

Demographic and clinical data will be collected including age, height, weight, smoking status, comorbidities (HTN, DM, CHF/CAD), history of urinary tract infections or retention, medication use (alpha-blockers, 5-ARI, anticholinergics), and medication adherence. Objective parameters such as prostate volume, PSA, serum creatinine, and estimated glomerular filtration rate (eGFR) will also be recorded.

The study will explore statistical associations between uroflowmetry curve types and symptom severity across the IPSS domains. The goal is to identify specific curve types that may correlate with increased symptom burden and/or predict surgical preference. Data analysis will include descriptive statistics, correlation analysis, and regression modeling as appropriate.

This study does not involve any experimental intervention and poses minimal risk to participants. All procedures and assessments are part of routine clinical practice. Ethical approval has been obtained, and informed consent will be acquired from all participants.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* Male patients aged 40 years or older
* Presenting with lower urinary tract symptoms (LUTS)
* Able to complete the IPSS questionnaire
* Underwent uroflowmetry and serum creatinine testing

Exclusion Criteria:

* History of prior prostate surgery
* Active urinary tract infection
* Known diagnosis of neurogenic bladder
* Current use of indwelling urinary catheter

Primary outcomes:
measure: Association between uroflowmetry curve type and total IPSS score
timeFrame: At baseline (single time point)
Secondary outcomes:
measure: Association between uroflowmetry curve type and IPSS storage symptom sub-score
timeFrame: At baseline
measure: Association between uroflowmetry curve type and IPSS voiding symptom sub-score
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Tarcan, T., et al. (2024). "ICS educational module: The practice of uroflowmetry in adults." Continence 9: 101065