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A prospective, observational population-based epidemiological study of home-based Uroflowmetry
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注册号:

Registration number:

ChiCTR2100054334 

最近更新日期:

Date of Last Refreshed on:

2021-12-14 

注册时间:

Date of Registration:

2021-12-14 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

此为补注册,需在www.medresman.org上建立项目、审核原始数据并公示后才能补注册 基于人口的前瞻性、观察性、居家尿流率流行病学研究 

Public title:

A prospective, observational population-based epidemiological study of home-based Uroflowmetry  

注册题目简写:

居家尿流率流行病学研究 

English Acronym:

HUES 

研究课题的正式科学名称:

老年尿失禁智能化评估技术和平台的建立 

Scientific title:

Establishment of intelligent assessment technology and platform for senile urinary incontinence  

研究课题代号(代码):

Study subject ID:

2018YFC2002202 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

刘晓东 

研究负责人:

张耀光 

Applicant:

Xiaodong Liu 

Study leader:

Yaoguang Zhang 

申请注册联系人电话:

Applicant telephone:

17601049152 

研究负责人电话:

Study leader's telephone:

13031099662 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

kwill@pku.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhang003887@sina.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市东城区东单大华路1号 北京医院 

研究负责人通讯地址:

北京市东城区东单大华路1号 北京医院 

Applicant address:

NO.1 Dahua Road, Dongdan,Dongcheng Beijing 

Study leader's address:

NO.1 Dahua Road, Dongdan,Dongcheng Beijing 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

北京医院 

Applicant's institution:

Beijing Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020BJYYEC-085-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

北京医院伦理委员会 

Name of the ethic committee:

Beijing Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-08 

伦理委员会联系人:

张弼 

Contact Name of the ethic committee:

Bi Zhang 

伦理委员会联系地址:

北京市东城区东单大华路1号 北京医院 

Contact Address of the ethic committee:

NO.1 Dahua Road, Dongdan,Dongcheng Beijing 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

北京医院 

Primary sponsor:

Beijing Hospital 

研究实施负责(组长)单位地址:

北京市东城区东单大华路1号 北京医院 

Primary sponsor's address:

NO.1 Dahua Road, Dongdan,Dongcheng Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

东城

Country:

China

Province:

Beijing

City:

Dongcheng

单位(医院):

北京医院

具体地址:

北京市东城区东单大华路1号 北京医院

Institution
hospital:

Beijing Hospital

Address:

NO.1 Dahua Road, Dongdan,Dongcheng Beijing

国家:

中国

省(直辖市):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

华西医院

具体地址:

四川省成都市国学巷37号

Institution
hospital:

West China Hospital

Address:

No.37 Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

香港科技大学霍英东研究院

具体地址:

广州市南沙区环市大道南沙科技园

Institution
hospital:

Hong Kong University of Science and TechnologyFok Ying Tung Foundation

Address:

S&T Building, Nansha IT Park, No. 2 Huan Shi Da Dao Road, Nansha District, Guangzhou City,

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学附属第一医院

具体地址:

浙江省杭州市上城区庆春路79号

Institution
hospital:

The First Affiliated Hospital, Zhejang University School of Medicine

Address:

79 Qingchun Rd., Shangcheng District, Hangzhou

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

中部战区总医院

具体地址:

武汉市洪山区武珞路627号

Institution
hospital:

General Hospital of Central theatre command

Address:

627 Wuluo Road, Hongshan District, Wuhan city

经费或物资来源:

中央财政专项基金 

Source(s) of funding:

Special funds from the central government 

研究疾病:

尿失禁 

Target disease:

Urinary Incontinence 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

完善现有的评估诊断的方法,调查中国各年龄段人群尿流率的流行病学数据。 

Objectives of Study:

To improve the existing methods of assessment and diagnosis and investigate the epidemiological data of urinary flow rate of Chinese people of all ages. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

(1)检测人群:正常人群4000例,入组人群体格发育正常,自身无明显不适,体检结果正常。 (2)南方和北方人群的比例约为1:1,两人群各不少于2000例(根据身份证地址确定,北方省市:北京、天津、宁夏、内蒙古、新疆、黑龙江、吉林、辽宁、河南、河北、陕西、甘肃、山西、山东、青海;南方省市:湖南、湖北、江苏、浙江、台湾、福建、江西、上海市、广东、广西、海南、香港、澳门、云南、贵州、四川、西藏、重庆)。 (3)城市和乡村人群的比例约为1.3:1,两人群各不各不少于2000例(根据身份证地址确定,城市定义:国家按行政建制设立的直辖市、市、镇。)。 (4)年龄分段:18-29岁、30-39岁、40-49岁、50-59岁、60-69岁、70-79岁、≥80岁,每年龄段至少检测600例。 (5)男女性别比约为1:1。 

Inclusion criteria

(1) Sample size: 4000 normal people, with normal physical examination results. (2) The proportion of people in the south and the north is about 1:1, and each of the two groups is not less than 2000 cases (according to the ID address to determine, northern provinces and cities: Beijing, Tianjin, Ningxia, Inner Mongolia, Xinjiang, Heilongjiang, Jilin, Liaoning, Henan, Hebei, Shaanxi, Gansu, Shanxi, Shandong, Qinghai; Southern Provinces and cities: Hunan, Hubei, Jiangsu, Zhejiang, Taiwan, Fujian, Jiangxi, Shanghai, Guangdong, Guangxi, Hainan, Hong Kong, Macao, Yunnan, Guizhou, Sichuan, Xizang, Chongqing). (3) The proportion of urban and rural population is about 1.3:1, and each of the two groups is not less than 2000 cases (according to the ID card address, the definition of city: the state according to the administrative system of the municipality, city, town.). (4) Age segmentation: 18-29 years old, 30-39 years old, 40-49 years old, 50-59 years old, 60-69 years old, 70-79 years old, ≥80 years old, at least 600 cases were detected in each age group. (5) The sex ratio is about 1:1. 

排除标准:

(1)认知功能障碍及依从性欠佳,无法配合使用仪器者; (2)有下尿路症状(Lower Urinary Tract Symptoms)患者曾经或当前正在接受临床干预治疗; (3)明确的脑血管疾病及神经系统疾病等影响患者排尿的合并症(如帕金森、重症肌无力、脊柱裂等); (4)严重精神、神经障碍疾病且不能配合完成调查者; (5)明确有既往下尿路手术史者。 (6)有恶性肿瘤病史者 

Exclusion criteria:

(1) Cognitive dysfunction and poor compliance, unable to use home-based uroflowmetry; (2) Patients with Lower Urinary Tract Symptoms have received or are currently receiving clinical intervention; (3) Complications of cerebrovascular diseases and nervous system diseases affecting patients' urination (such as Parkinson's disease, myasthenia gravis, spina bifida, etc.); (4) serious mental and neurological disorders and unable to cooperate with the investigators; (5) Lower urinary tract surgery history. (6) Urinary malignancy. 

研究实施时间:

Study execute time:

From2020-06-01To 2022-12-30 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2022-12-30 

干预措施:

Interventions:

组别:

正常人群

样本量:

4000

Group:

normal people

Sample size:

干预措施:

none

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng 

单位(医院):

北京医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing hospital  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

北京市 

市(区县):

丰台区 

Country:

China 

Province:

Beijing 

City:

Fengtai 

单位(医院):

中国康复中心 

单位级别:

三甲医院 

Institution
hospital:

China Rehabilitation Research Center  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

北京市 

市(区县):

朝阳区 

Country:

China 

Province:

Beijing 

City:

Chaoyang 

单位(医院):

首都医科大学附属朝阳医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Chao-Yang Hospital  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

北京市 

市(区县):

海淀 

Country:

China 

Province:

Beijing 

City:

Haidian 

单位(医院):

北京大学第三医院 

单位级别:

三甲医院 

Institution
hospital:

Peking university Third Hospital  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东大学齐鲁医院 

单位级别:

三甲医院 

Institution
hospital:

Qilu Hospital Of Shandong University  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The Fist Affiliated Hospital, Zhejiang University School Of Medicine  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji Hospital Tongji Medical College Of HUST  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

南京 

市(区县):

鼓楼 

Country:

China 

Province:

Nanjing 

City:

Gulou 

单位(医院):

南京医科大学第二附属医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Affiliated Hospital of Nanjing Medical University  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学孙逸仙纪念医院 

单位级别:

三甲医院 

Institution
hospital:

SUN YAT-SEN MEMORIAL HOSPITAL  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中国人民解放军南部战区总医院 

单位级别:

三甲医院 

Institution
hospital:

General Hospital Of Southern Theatre Command  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

北京 

市(区县):

西城 

Country:

China 

Province:

Beijing 

City:

Xicheng 

单位(医院):

北京大学第一医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University First Hospital  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

北京 

市(区县):

朝阳 

Country:

China 

Province:

Beijing 

City:

Chaoyang 

单位(医院):

中日友好医院 

单位级别:

三甲医院 

Institution
hospital:

China-Japan Friendship Hospital  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Zhengzhou University  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

天津 

市(区县):

河西 

Country:

China 

Province:

Tianjing 

City:

Hexi 

单位(医院):

天津医科大学第二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Hospital of Tianjin Medical University  

Level of the institution:

3A 

国家:

中国 

省(直辖市):

贵州 

市(区县):

遵义 

Country:

China 

Province:

Guizhou 

City:

Zunyi 

单位(医院):

遵义医科大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of Zunyi Medical University  

Level of the institution:

3A 

测量指标:

Outcomes:

指标中文名:

排尿时间

指标类型:

主要指标 

Outcome:

voiding time

Type:

Primary indicator 

测量时间点:

测量方法:

home-based uroflowmetry

Measure time point of outcome:

Measure method:

指标中文名:

平均尿流率

指标类型:

主要指标 

Outcome:

Qave

Type:

Primary indicator 

测量时间点:

测量方法:

home-based uroflowmetry

Measure time point of outcome:

Measure method:

指标中文名:

排尿量

指标类型:

主要指标 

Outcome:

Voided volume

Type:

Primary indicator 

测量时间点:

测量方法:

home-based uroflowmetry

Measure time point of outcome:

Measure method:

指标中文名:

最大尿流率

指标类型:

主要指标 

Outcome:

Qmax

Type:

Primary indicator 

测量时间点:

测量方法:

home-based uroflowmetry

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

Urine

组织:

Sample Name:

尿液

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 89 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究为观察性研究,采用分层随机抽样方法,以南北方、城乡、性别及不同年龄段等不同层次按照一定比例对我国健康人群进行随机抽样。

Randomization Procedure (please state who generates the random number sequence and by what method):

This study is an observational study, using stratified random sampling method, south and north, urban and rural, gender and different age groups in China according to a certain proportion of random sampling.

盲法:

Blinding:

是否共享原始数据:

IPD sharing

Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

完成研究后,原始数据将提交至中国生物技术发展中心下设的国家人口健康科学数据中心

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

the raw data will be submitted to the National Data Center for Population Health Sciences under the China Biotechnology Development Center;www.ncmi.cn

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据采集:电子问卷及居家尿流率无线传输系统 数据管理:电子采集和管理系统(https://www.clinpath.cn/flow-test/flow-test-admin/#/login)

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data collection: electronic questionnaire and home-based uroflowmetry wireless transmission system Data management: Electronic Data Capture(https://www.clinpath.cn/flow-test/flow-test-admin/#/login)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-14
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