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临床试验/NCT06448533
NCT06448533已完成不适用

The Predictive Value of Prostate Spherical Volume Ratio in Lower Urinary Tract Symptoms and Clinical Progression of Benign Prostatic Hyperplasia:A Single-center Paired Validating Confirmatory Study

Shanghai East Hospital1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2022年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
1
主要终点
clinical progression of benign prostatic hyperplasia

研究概览

简要总结

This study was a retrospective cohort study clinical trial designed to assess the predictive ability of the prostate morphometric parameter, Prostate Spherical Volume Ratio, in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia; and to compare the predictive ability of other anatomical parameters of the prostate (prostatic urethral length, intravesical prostatic protrusion, presumed circle area ratio, and prostate volume) in the lower urinary tract symptoms and clinical progression of benign prostatic hyperplasia

详细描述

This was a retrospective observational study approved by the Ethics Committee of Shanghai Oriental Hospital. We collected patients with BPH who underwent MRI, urine flow measurement and completed the IPSS questionnaire in our hospital between September 2022 and April 2023, measured each anatomical parameter of the patient's prostate by MRI, analysed the relationship of these prostate parameters with IPSS and urine flow, and conducted a follow-up of the clinical progression of the prostate in these patients to evaluate the predictive efficacy of prostate parameters for LUTS and clinical progression of benign prostatic hyperplasia.

研究设计

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

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

  • All patients had obvious lower urinary tract symptoms such as urinary frequency, increased nocturia, and a feeling of incomplete urination, etc. They all completed prostate MRI, IPSS questionnaire, and uroflowmetry for a clear diagnosis of BPH.

排除标准

  • 1, previous history of bladder, prostate, urethra surgery; 2, the existence of other diseases that cause urinary dysfunction: such as neurogenic bladder, bladder stones, urethral stenosis, urinary tract infections, acute prostatitis, etc.; 3, the existence of mental, mental disorders, can not be accurately expressed and family members can not help to improve the IPSS scores; 4, to receive prostatic hyperplasia medication, such as: α-blocker therapy, 5α reductase inhibitors, etc. have not been discontinued for 6 months; 5, refused to participate in this study

结局指标

主要结局

clinical progression of benign prostatic hyperplasia

时间窗: 1 year of observation and follow-up after enrolment

The primary outcome, described as clinical progression of benign prostatic hyperplasia, was the first occurrence of an increase in the IPSS of at least 4 points, benign prostatic hyperplasia-related prostatic surgery

次要结局

未报告次要终点

研究者

发起方
Shanghai East Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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