Uroflowmetry Curve Types and IPSS in Men With LUTS

NCT ID: NCT07016776

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-06-15

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.

Conditions

Lower Urinary Tract Symptoms (LUTS); Benign Prostatic Hyperplasia (BPH); Voiding Dysfunction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tarik Emre Sener

OTHER

Sponsor Role: lead

Responsible Party

Tarik Emre Sener

Assoc. Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Gunal Ozgur MD, FEBU, Urology Specialist

Role: CONTACT

gunalozgur91@hotmail.com

+905357849485

References

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

Reference Type: RESULT

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

MAR.UAD.0022

Identifier Type: -

Identifier Source: org_study_id