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临床试验/NCT07016776
NCT07016776尚未招募不适用

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

Tarik Emre Sener0 个研究点目标入组 250 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
主要终点
Association between uroflowmetry curve type and total IPSS score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Association between uroflowmetry curve type and total IPSS score

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Tarik Emre Sener
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tarik Emre Sener

Assoc. Prof.

Marmara University

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Uroflowmetry Curve Types and IPSS in Men With LUTS | 临床试验