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临床试验/NCT04870749
NCT04870749已完成不适用

Diagnostic Role of Visual Prostate Symptom Score and Intravesical Prostatic Protrusion in Male Lower Urinary Tract Symptoms

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
219
试验地点
1
主要终点
The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.

研究概览

简要总结

The diagnosis of bladder outlet obstruction is made by pressure-flow studies, which is an invasive method. This study was conducted to evaluate non-invasive, effective, and low-cost diagnostic methods in male patients with bladder filling and emptying abnormalities.

详细描述

Aims The diagnosis of bladder outlet obstruction is made by pressure-flow studies, which is an invasive method. This study was conducted to evaluate non-invasive, effective, and low-cost diagnostic methods in male patients with bladder filling and emptying abnormalities.

Methods The study included 219 male patients aged 50 and over, who were admitted between March 2020 and August 2020. Patients completed the Visual Prostate Symptom Score (VPSS) along with International Prostate Symptom Score (IPSS). Intravesical prostatic protrusion (IPP), prostate volume, bladder volume, and post voiding residual urine (PVR) were measured by suprapubic ultrasound. Urethral resistance was calculated using the Bladder Outlet Obstruction Number (BOON), and patients over -20 were considered obstructed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Clinical diagnosis of BPH Disease

排除标准

  • Patients with previous urological surgery
  • History of urological malignancy
  • Systemic disease (diabetes mellitus, multiple sclerosis, etc.)
  • Trauma that may cause LUTS
  • Pharmacotherapy for LUTS
  • Use diuretic antihypertensive
  • PSA > 4 ng/dl
  • History of pelvic radiotherapy
  • Visual problems that could not complete the VPSS test were not included.

结局指标

主要结局

The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.

时间窗: During the patient's outpatient clinic examination

In this study, it is aimed to determine the use of VPSS instead of IPSS when needed, the importance of IPP in evaluating LUTS, and the correlation of IPP with VPSS and IPSS, based on BOON in the diagnosis of obstruction. The data obtained from the study were evaluated with the SPSS 23.0 program. The normality rankings of the data were made by the Shapiro-Wilk test. Since the data are non-parametric, the Spearman correlation test was performed. The Kruskal-Wallis test was performed for calculating the difference of IPSS groups (mild, moderate, severe) according to other parameters. In case of difference, the Mann-Whitney U test was applied to understand which two groups were different. Since the IPP groups (\<5mm, 5-10mm, \>10mm) conformed to the normal distribution, Post-Hoc (Bonferroni) test was used to determine the differences between the 3 groups. The level of error was taken as 0.05.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huseyin Saygin

Assistant Professor Department of Urology

Cumhuriyet University

研究点 (1)

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