The Association of Baseline Characteristics of Male Patients Presented With LUTS and Long Term Clinical Outcomes
2021年2月18日 更新者：Chi Fai NG、Chinese University of Hong Kong
A Retrospective Review of the Association of Baseline Characteristics of Male Patients Presented With Lower Urinary Tract and Long Term Clinical Outcomes
Non-neurogenic male lower urinary tract symptom (LUTS) is one of the most common symptom presented in urological clinic.
Male LUTS could be a result of a combination of many different conditions, including benign prostate hypertrophy, overactive bladder, diabetes, noctural polyuria, sleep apnoea etc.
Also male LUTS has shown to have close relationship with metabolic and cardiovascular conditions.
Because of the increasing evidences to suggest a close relationship of cardiovascular condition and metabolic problems and male LUTS, this is a study to retrospective review of the patients assessed in this urology clinic and have a more in-depth assessment of the relationship of the baseline characteristics of these medical conditions with the presenting symptoms, as well as the long term urological and overall clinical outcomes of these patients.
研究概览
详细说明
This is a retrospective study.Male patients who presented with lower urinary tract symptom to our centre and assessed in the urology clinic from 2005 to 2019 would be enrolled to the study.
This study will be conducted by observation; that is, data will be captured from medical records and central medical system (CMS), but patients will not be contacted.
All the demographic and medical background, as well as investigations performed during the assessment including uroflowmetry, post-voiding residual, questionnaires, blood pressure, pulse, vascular assessment and blood result will be collected.
Follow-up data including usage of medication, clinical outcomes (such as development of urinary retention, cardiovascular events, need of surgical intervention, mortality etc.) will be captured from the medical records.
研究类型
观察性的
注册 (实际的)
246
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Shatin、香港
- Prince of Wales Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
非概率样本
研究人群
Male patients who presented with lower urinary tract symptom to our centre and assessed in the nurse-led pre-assessment clinic
描述
Inclusion Criteria:
- Men aged between 35 and 90 years old with LUTS/nocturia and received assessment at urology centre.
Exclusion Criteria:
- Men having history of prostatic surgery, prostate cancer, active urinary tract infection, aortic aneurysm, marked cardiac arrhythmia and severe peripheral vascular disease
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
LUTS/Nocturia
Patients with LUTS / Nocturia
|
本研究没有干预
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The overall prevalence of adverse cardiovascular events (MACE) in male patients presented with lower urinary tract symptoms (LUTS)
大体时间：Through study completion, an average of 2 years
|
Major adverse cardiovascular events such as myocardial infraction, ischemic heart disease, heart failure, coronary angioplasty etc. in male patients with LUTS.
It is assessed by medical record
|
Through study completion, an average of 2 years
|
|
The overall prevalence of diabetes in male patients presented with lower urinary tract symptoms (LUTS)
大体时间：Through study completion, an average of 2 years
|
It is assessed by medical record
|
Through study completion, an average of 2 years
|
|
The overall prevalence of dyslipidaemia in male patients presented with lower urinary tract symptoms (LUTS)
大体时间：Through study completion, an average of 2 years
|
It is assessed by medical record
|
Through study completion, an average of 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between nocturia and Central arterial stiffness (CAS)
大体时间：Baseline
|
Nocturia is assessed by International Prostate Symptom Score Question 7, high value means worser nocturia; CAS is assessed by brachial-ankle PWV (baPWV), the value >1800cm/sec is highly associated with development of MACE
|
Baseline
|
|
Incidence of acute retention of urine
大体时间：Through study completion, an average of 2 years
|
It is assessed by medical record
|
Through study completion, an average of 2 years
|
|
Incidence of requirement of surgical intervention
大体时间：Through study completion, an average of 2 years
|
It is assessed by medical record
|
Through study completion, an average of 2 years
|
|
Overall mortality
大体时间：Through study completion, an average of 2 years
|
It is assessed by medical record
|
Through study completion, an average of 2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ng CF, Wong A, Li ML, Chan SY, Mak SK, Wong WS. The prevalence of cardiovascular risk factors in male patients who have lower urinary tract symptoms. Hong Kong Med J. 2007 Dec;13(6):421-6.
- Yee CH, Yip JSY, Cheng NMY, Kwan CH, Li KM, Teoh JYC, Chiu PKF, Wong JH, Chan ESY, Chan CK, Hou SSM, Ng CF. The cardiovascular risk factors in men with lower urinary tract symptoms. World J Urol. 2019 Apr;37(4):727-733. doi: 10.1007/s00345-018-2432-2. Epub 2018 Aug 6.
- Teoh JY, Chan CK, Wang MH, Leung CH, Chan ES, Chiu PK, Yee CH, Wong HM, Hou SS, Ng CF. Transurethral resection of prostate for acute urinary retention is linked to shorter survival in younger men. Asian J Androl. 2019 Sep-Oct;21(5):468-472. doi: 10.4103/aja.aja_101_18.
- Everaert K, Anderson P, Wood R, Andersson FL, Holm-Larsen T. Nocturia is more bothersome than daytime LUTS: Results from an Observational, Real-life Practice Database including 8659 European and American LUTS patients. Int J Clin Pract. 2018 Jun;72(6):e13091. doi: 10.1111/ijcp.13091. Epub 2018 May 16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年10月2日
初级完成 (实际的)
2020年12月7日
研究完成 (实际的)
2020年12月7日
研究注册日期
首次提交
2021年2月16日
首先提交符合 QC 标准的
2021年2月18日
首次发布 (实际的)
2021年2月21日
研究记录更新
最后更新发布 (实际的)
2021年2月21日
上次提交的符合 QC 标准的更新
2021年2月18日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.