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临床试验/NCT05292235
NCT05292235招募中不适用

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong

Chinese University of Hong Kong3 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
3
主要终点
International Prostate Symptom Score (IPSS) questionnaire total Score

研究概览

简要总结

This is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters.

详细描述

Benign prostatic hyperplasia (BPH) is a very common disease affecting men. Patients with BPH may present with voiding symptoms including hesitancy, intermittence, slow stream and sensation of incomplete emptying, and storage symptoms including urinary frequency, urgency and nocturia. Patients may also suffer from complications including urinary retention, recurrent urinary tract infection, bladder stone formation and obstructive uropathy. For patients who have lower urinary tract symptoms refractory to medications, or those who suffer from complications of BPH, transurethral prostatectomy should be considered.

Surgical intervention options have evolved from electrosurgical resection to the use of lasers for enucleation and ablation [1]. Aquablation and Rezum system are new minimally invasive surgical technology for BPH management. [2,3,4]. Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients.

However, large-scale studies investigating the different modalities of surgical treatment of BPH are lacking. Therefore, a prospective data registry is created to assess the perioperative surgical outcomes for different surgical treatment of BPH.

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
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patient at the age of 18 or above

排除标准

  • Patient is unable to give consent

结局指标

主要结局

International Prostate Symptom Score (IPSS) questionnaire total Score

时间窗: Baseline, 3 months after surgical treatment for BPH

Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires

Voiding function in uroflowmetry

时间窗: Baseline, 3 months after after surgical treatment for BPH

Change in urodynamic function assessed by Uroflowmetry

次要结局

  • Complication after surgical treatment(Post operation 30 days after surgical treatment for BPH)

研究者

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

NG Chi Fai

Professor

Chinese University of Hong Kong

研究点 (3)

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