Uroflowmetry Curve Types and IPSS in Men With LUTS

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.

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Key information

Conditions

Lower Urinary Tract Symptoms (LUTS) Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations Voiding Dysfunction

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

Association between uroflowmetry curve type and total IPSS score

Time frame: At baseline (single time point)

Assessment of the relationship between different uroflowmetry curve patterns (normal, plateau, staccato, intermittent, tower) and total International Prostate Symptom Score (IPSS) in men with LUTS.

Secondary outcomes

Association between uroflowmetry curve type and IPSS storage symptom sub-score

Time frame: At baseline

Evaluation of the correlation between flow curve pattern and IPSS storage domain (questions 2, 4, and 7).
Association between uroflowmetry curve type and IPSS voiding symptom sub-score

Time frame: At baseline

Evaluation of the correlation between flow curve pattern and IPSS voiding domain (questions 1, 3, 5, and 6).

Study contacts

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

Gunal Ozgur MD, FEBU, Urology Specialist

CONTACT

[email protected]

+905357849485

Sponsors and collaborators

Lead sponsor

Tarik Emre Sener

Other

Registry information

Official study title

Evaluation of the Association Between Uroflowmetry Curve Patterns and IPSS Domains in Men With Lower Urinary Tract Symptoms

Acronym: UROFLOW-IPSS

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jun 12, 2025
Registry last updated: Sep 3, 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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Completed