Uroflowmetry Curve Types and IPSS in Men With LUTS

NCT07016776 | Not Yet Recruiting

• 1 other identifier: MAR.UAD.0022
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Association between uroflowmetry curve type and total IPSS score

  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.

  At baseline (single time point)

Secondary Outcomes (2)

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

  At baseline

• Association between uroflowmetry curve type and IPSS voiding symptom sub-score

  At baseline

Study Arms (1)

Men with LUTS (Lower Urinary Tract Symptoms)

Male patients aged 40 years and older presenting with lower urinary tract symptoms (LUTS), evaluated using the International Prostate Symptom Score (IPSS), uroflowmetry, and standard clinical parameters. All participants will be classified based on their uroflowmetry curve type and IPSS subdomain scores (storage and voiding symptoms).

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 and older with LUTS who presented to the urology department of a tertiary academic center.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tarik Emre Sener: lead

Related Publications (1)

• Tarcan, T., et al. (2024). "ICS educational module: The practice of uroflowmetry in adults." Continence 9: 101065

  RESULT

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Gunal Ozgur MD, FEBU, Urology Specialist

CONTACT

+905357849485; gunalozgur91@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 12, 2025
• Study Start: September 15, 2025
• Primary Completion: October 30, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share