女性压力性尿失禁综合治疗优化方案评价研究

注册号:

Registration number:

AMCTR-IOR-15000002 

注册号获得时间:

Date of releasing the registration number:

2015/9/11 9:04:48 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

女性压力性尿失禁综合治疗优化方案评价研究 

Public title:

Evaluation of Integrated Optimization Schemes for Female Stress Incontinence 

研究课题的正式科学名称:

女性压力性尿失禁综合治疗优化方案评价研究 

Scientific title:

Evaluation of Integrated Optimization Schemes for Female Stress 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:

汤康敏 

研究负责人:

陈跃来 

Applicant:

Tang Kangmin 

Study leader:

Chen Yuelai 

申请注册联系人电话:

Applicant telephone:

13761315502 

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:

kangmin_tang@163.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:

上海市蔡伦路1200号 

研究负责人通讯地址:

上海市蔡伦路1200号 

Applicant address:

No.1200 Cailun Road,Shanghai 

Study leader's address:

No.1200 Cailun Road,Shanghai 

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 and 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2014伦理审查005号 

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:

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:

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

伦理委员会批准日期:

Date of approved by ethic committee:

2014-03-20 

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 and Chinese Medicine 

研究实施负责(组长)单位地址:

上海市甘河路110号 

Primary sponsor's address:

No.100 Ganhe Road,Shanghai 

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

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:

上海市甘河路110号

Institution
hospital:

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

Address:

经费或物资来源:

中国中医药科学院中医临床基础医学研究所 

Source(s) of funding:

The foundation medicine nstitute of traditional Chinese Medicine,the Chinese Academy of Traditional Chinese Medicine 

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:

II期临床试验 

Study phase:

Prevention II 

研究目的:

通过多中心随机、对照的临床研究,对电针结合盆底肌功能锻炼、安慰电针结合盆底肌功能锻炼治疗女性压力性尿失禁技术方案的有效性及安全性进行客观地验证和评价。 

Objectives of Study:

Through multi-center, randomized, and controlled clinical studies to evaluate the effectiveness and safety of electric acupuncture combined with pelvic diaphragm exercise and placebo electric acupuncture combined with pelvic diaphragm exercise in female stress urinary incontinence. 

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; ③签署知情同意书,自愿参加研究者。 

Inclusion criteria

(1) Meet the female stress related incontinence diagnostic criteria; (2) Age of 40 ~ 75 years old; (3) Signed the informed consent and volunteered for the research. 

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; ⑾安装心脏起搏器,金属过敏或严重惧针者。 

Exclusion criteria:

①urge incontinence,mixed urinary incontinence,overflow incontinence,etc; ②History of surgical operation in treating urinary incontinence and pelvic surgery; ③edeoptosis≥Ⅱ°; ④urinary infection; ⑤residual urine>30ml; ⑥Qmax>30ml; ⑦With difficulty for walking and running; ⑧Accepting drug treatment which may affect bladder function or is being treated for a specific stress urinary incontinence; ⑨ With severe cardiac, brain, hepatic, renal disease and hematopoietic system and mental disorders, diabetes, multiple system atrophy, horsetail neurological damage, spinal cord lesions; ⑩pregnant or lactating women; ⑾cardiac pacemaker carrier, allergic to metal, or highly fears needles. 

研究实施时间:

Study execute time:

From2013-12-01To 2015-12-31 

干预措施:

Interventions:

组别:

1

样本量:

155

Group:

1

Sample size:

干预措施:

电针结合盆底肌训练

干预措施代码:

Intervention:

electric acupuncture combined with pelvic diaphragm exercise

Intervention code:

组别:

1

样本量:

155

Group:

1

Sample size:

干预措施:

安慰电针结合盆底肌训练

干预措施代码:

Intervention:

placebo electric acupuncture combined with pelvic diaphragm exercise

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

China 

市(区县):

上海市 

Country:

Shanghai 

Province:

 

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:

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

Institution
hospital:

三级甲等  

Level of the institution:

Third rate 

测量指标:

Outcomes:

指标中文名:

和基线相比,基于72h排尿日记卡的平均24h尿失禁次数的减少值

指标类型:

主要指标 

Outcome:

relative to the baseline,the average reduction in incidences of urinary incontinence in a 24 hour interval based on the 72 hour log of urinary activity

Type:

Primary indicator 

指标中文名:

和基线相比,平均24h漏尿程度(基于72h排尿日记卡)

指标类型:

主要指标 

Outcome:

relative to the baseline,the average extent of urine leakage in a 24 hour interval (based on the 72 hour log of urinary activity)

Type:

Primary indicator 

指标中文名:

严重指数评价表:漏尿次数×漏尿程度

指标类型:

主要指标 

Outcome:

severity index table : frequency of urinary incontinence X extent of urinary incontinence

Type:

Primary indicator 

指标中文名:

和基线相比,1h尿垫试验漏尿量的变化值

指标类型:

次要指标 

Outcome:

relative to the baseline,amount of urinary incontinence leakage after 1 hour of testing with a diaper

Type:

Secondary indicator 

指标中文名:

ICIQ-SF量表(国际尿失禁咨询委员会问卷表简表)

指标类型:

次要指标 

Outcome:

ICIQ-SF scale

Type:

Secondary indicator 

指标中文名:

基于72h排尿日记的尿失禁漏尿程度评价

指标类型:

次要指标 

Outcome:

relative to the baseline, evaluation of the extent of urinary incontinence leakage based on the 72 hour log of urinary activity

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:

Patient self-reported efficacy evaluation

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:

Average diaper usage per week

Type:

Secondary indicator 

指标中文名:

压力性尿失禁专科治疗应用情况

指标类型:

次要指标 

Outcome:

Stress urinary incontinence specialist treatment

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

尿液

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:

正在进行

Recruiting

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):

采用分层区组随机化方法,将中心作为分层因素,按照1:1的比例将受试者随机分配到试验组和对照组。采用SAS9.3统计分析软件的“Proc plan” 程序产生研究所需的随机方案。随机化过程中设定的各参数等相关内容均保存在盲底中。采用临床研究中央随机系统(中国中医科学院临床评价中心提供)进行随机化操作。当合格受试者入组时,由各中心负责随机化的人员或临床研究者通过电话或网络登陆中央随机系统进行随机号的申请。

性别:

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

For each testing center, the subjects were randomly divide into two equal groups, the experiment group and the control group. The "Proc plan" program within the SAS 9.3 statistical analysis software was used to generate the experiment setup. The various parameters and relatd content during the randomization process were kept blinded.Randomization was performed using the central clinical research randomization system (provided by the China Academy of Traditional Chinese Medicine clinical evaluati

Gender:

盲法:

盲患者,并采用盲法评价,由不知分组情况的第三方进行疗效评价;资料总结阶段采用盲法统计分析,实行研究者、操作者、统计者三分离。

Blinding:

Patients are blinded,and assessed by third party without knowing the grouping.Also blind the final concluding periods of data analyses by separated the research,the operation and the data collection.

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):

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

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):

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

创建人:

Creater Name:

 2015-03-12
返回列表