电针治疗女性压力性尿失禁适宜技术研发与推广应用研究

注册号:

Registration number:

AMCTR-IOR-16000027 

注册号获得时间:

Date of releasing the registration number:

2016/12/26 10:20:00 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

电针治疗女性压力性尿失禁适宜技术研发与推广应用研究 

Public title:

The research and development and popularization of suitable technology applications project of electroacupuncture therapy for treatment of stress urinary incontinence 

研究课题的正式科学名称:

电针治疗女性压力性尿失禁适宜技术研发与推广应用研究 

Scientific title:

The research and development and popularization of suitable technology applications project of electroacupuncture therapy for treatment of stress urinary incontinence 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

王茜 

研究负责人:

陈跃来 

Applicant:

Xi Wang 

Study leader:

Yuelai Chen 

申请注册联系人电话:

Applicant telephone:

15800850761 

研究负责人电话:

Study leader's telephone:

13020193726 

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:

450364506@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

chenyuelai@163.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:

上海市虹口区甘河路110号岳阳医院学生公寓 

研究负责人通讯地址:

上海市浦东新区蔡伦路1200号上海中医药大学图书馆裙楼2楼研究生院办公室 

Applicant address:

110 Ganhe Road, Hongkou District, Shanghai, China 

Study leader's address:

1200 Cailun Road, Pudong New District, Shanghai, China 

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:

上海中医药大学附属岳阳中西医结合医院 

Applicant's institution:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

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:

上海中医药大学附属岳阳中西医结合医院伦理委员会2016伦理审查080号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海中医药大学附属岳阳中西医结合医院伦理委员会 

Name of the ethic committee:

IRB of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-11-15 

研究实施负责(组长)单位:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号 

Primary sponsor's address:

110 Ganhe Road, Hongkou District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road, Hongkou District, Shanghai, China

经费或物资来源:

上海市申康医院发展中心 

Source(s) of funding:

Shanghai Shenkang hospitals development center 

研究疾病:

压力性尿失禁 

Target disease:

stress urinary incontinence 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

对电针、盆底肌训练治疗女性压力性尿失禁疗效和安全性等进行评价研究。确立以电针结合盆底肌训练方法为主的防治女性压力性尿失禁优化方案的规范化适宜技术。开展适宜技术的临床推广应用。 

Objectives of Study:

To objectively verify and evaluate the clinical efficacy and dose-effect relationship and safety of electroacupuncture combined with pelvic floor muscle training in the treatment of stress urinary incontinence and to provide the scientific basis for optimizing the technology standardization of electroacupuncture combined with pelvic floor muscle training in the treatment of stress urinary incontinence. In order to promote the application of appropriate technology. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

①符合女性单纯性压力性尿失禁的诊断标准; ②年龄为40~75岁,女性; ③签署知情同意书,自愿参加研究者。 

Inclusion criteria

1. Diagnosis in accordance with the diagnostic criteria for clinical symptoms and signs of SUI; 2. Aged 40 to 75 years femal;; 3. Participate in the study voluntarily and sign informed consent. 

排除标准:

①急迫性尿失禁、混合性尿失禁及充溢性尿失禁等; ②尿失禁手术治疗史或盆底手术史; ③生殖器脱垂≥2度; ④症状性泌尿系感染; ⑤残余尿>30ml; ⑥最大尿流率<20ml/s; ⑦步行、上下楼、跑步不能或受限者; ⑧一直使用可能影响膀胱功能的药物或正在接受压力性尿失禁专科治疗者; ⑨伴有严重心、脑、肝、肾及造血系统和精神疾患者,糖尿病、多系统萎缩、马尾神经病损、脊髓病变患者; ⑩妊娠或哺乳期; ?安装心脏起搏器,金属过敏或严重惧针者。 

Exclusion criteria:

1.Urgent urinary incontinence/mixed urinary incontinence or plentiful urinary incontinence; 2.Surgery for incontinence or pelvic floor muscle; 3.edeoptosis≥II; 4.urinary system infection; 5.the residual urine>30ml; 6.the max urinary flow<20ml/s; 7.unable to walk/climb stairs/run; 8.keep taking medicine which may influence the function of bladder/accepting other treatment for incontinence; 9.with serious heart/brain/liver/kidney/blood systerm disease,mental disorder/diabetes/MSA/cauda equina disease/medulla spinalis disease; 10.pregnant or lactation period; 11.install with pacemaker; allergy to metal;feard of acupuncture. 

研究实施时间:

Study execute time:

From2016-12-01To 2018-12-31 

干预措施:

Interventions:

组别:

电针组

样本量:

142

Group:

Electroacupuncture

Sample size:

干预措施:

电针+盆底肌训练

干预措施代码:

Intervention:

Electroacupuncture+Pelvic floor muscle training

Intervention code:

组别:

对照组

样本量:

142

Group:

Control

Sample size:

干预措施:

安慰电针+盆底肌训练

干预措施代码:

Intervention:

Sham acupuncture+Plevic floor muscle training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine  

Level of the institution:

top three hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

静安区中医院 

单位级别:

二甲医院 

Institution
hospital:

Jingan District Hospital of Traditional Chinese Medicine  

Level of the institution:

Secondary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

嘉定区新城路街道社区卫生服务中心 

单位级别:

一甲医院 

Institution
hospital:

Xincheng Road Community Health Service Center,Jiading District  

Level of the institution:

first grade class a hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

虹口区广中路街道社区卫生服务中心 

单位级别:

一甲医院 

Institution
hospital:

Guangzhong Road Community Health Service Center,Hongkou District  

Level of the institution:

first grade class a hospital 

测量指标:

Outcomes:

指标中文名:

1h尿垫试验漏尿量

指标类型:

主要指标 

Outcome:

the volume of urine leakage of a one hour urinal pad test

Type:

Primary indicator 

指标中文名:

ICIQ-SF量表评分

指标类型:

次要指标 

Outcome:

the score of ICIQ-SF questionnaire

Type:

Secondary indicator 

指标中文名:

72h尿失禁次数

指标类型:

次要指标 

Outcome:

the frequency of urinary incontinence in 72h

Type:

Secondary indicator 

指标中文名:

尿失禁程度

指标类型:

次要指标 

Outcome:

the level of urinary incontinence

Type:

Secondary indicator 

指标中文名:

患者主观疗效评价

指标类型:

次要指标 

Outcome:

the subjective efficacy evaluation of patients

Type:

Secondary indicator 

指标中文名:

平均1周尿垫使用量

指标类型:

次要指标 

Outcome:

the usage amount of urinal pad in a week

Type:

Secondary indicator 

指标中文名:

尿失禁专科治疗应用情况

指标类型:

次要指标 

Outcome:

the treatment for incontinence

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

尿

组织:

Sample Name:

Urine

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:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

采用SPSS软件用计算机产生随机数字,随机编码表按病例入选的顺序排列。

性别:

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

The random number was generated by using SPSS software in the computer, and the random code table was arranged according to the sequence of cases.

Gender:

盲法:

病人、结局指标评价者、统计人员受盲

Blinding:

The patients,efficacy evaluate and statisticians are blinded

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

试验完成后6个月内通过Resman共享

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

IPD will be public accessible via ResMan at 2019.6

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

纸质和电子版,通过SPSS进行数据分析,通过Resman共享。

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Print and electronic ;The database is SPSS,IPD will be public accessible via ResMan.

创建人:

Creater Name:

 2016-11-03
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