电针治疗下运动神经源性慢性尿潴留的前瞻性预试验

注册号:

Registration number:

AMCTR-IPN-18000238 

注册号获得时间:

Date of releasing the registration number:

2018/12/20 14:30:28 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

电针治疗下运动神经源性慢性尿潴留的前瞻性预试验 

Public title:

Effects of electroacupuncture on patients with chronic urinary retention caused by lower motor neuron lesion: a prospective pilot study 

研究课题的正式科学名称:

电针治疗神经源性尿潴留的疗效评价 

Scientific title:

Effects of electroacupuncture on patients with neurogenic chronic urinary retention 

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:

周婧 

研究负责人:

刘志顺 

Applicant:

Zhou Jing 

Study leader:

Liu Zhishun 

申请注册联系人电话:

Applicant telephone:

15650729586 

研究负责人电话:

Study leader's telephone:

13651016313 

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:

zjinbj@126.com 

研究负责人电子邮件:

Study leader's E-mail:

liuzhishun@aliyun.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:

北京市西城区北线阁5号 

研究负责人通讯地址:

北京市西城区北线阁5号 

Applicant address:

5 Beixiange St., Xicheng District, Beijing, China 

Study leader's address:

5 Beixiange St., Xicheng District, Beijing, 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:

中国中医科学院广安门医院 

Applicant's institution:

Guang’an Men Hospital, China Academy of Chinese Medical Sciences 

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:

2016-125-KY-01 

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:

中国中医科学院广安门医院伦理委员会 

Name of the ethic committee:

Review boards and ethics committees, Guang’anmen Hospital, China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-02-20 

研究实施负责(组长)单位:

中国中医科学院广安门医院 

Primary sponsor:

Guang’an Men Hospital, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

中国中医科学院广安门医院 

Primary sponsor's address:

Guang’an Men Hospital, China Academy of Chinese Medical Sciences 

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):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang’an Men Hospital

Address:

No.5 Beixiange St., Xicheng District, Beijing, China

经费或物资来源:

“十三五”国家重点研发计划针灸优势病种疗效评价国际合作研究 

Source(s) of funding:

“The 13th Five-year’’ National Science and Technology Pillar Program (2017YFC1703602) by the Ministry of Science and Technology of the People’s Republic of China 

研究疾病:

慢性尿潴留 

Target disease:

Chronic urinary retention 

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:

预实验 

Study phase:

Polit 

研究目的:

评价电针治疗下运动神经源性慢性尿潴留的可行性。 

Objectives of Study:

The purpose of this prospective case series study was to assess the feasibility of electroacupuncture treatment for patients with chronic urinary retention caused by lower motor neuron lesion. 

研究设计:

无对照研究 

Study design:

Non-control study 

纳入标准:

1.符合下运动神经元损害所致慢性尿潴留的诊断;由骶髓、骶丛、马尾神经损伤、糖尿病、盆腔术后等所致的慢性尿潴留; 2.年龄大于18岁; 3.病程≥3个月; 4.残余尿量≥300 ml,但膀胱有感觉(有尿意); 5.间歇自家导尿或留置导尿; 6.至少接受4周治疗且有一次疗后数据; 7.签署知情同意书,自愿参与本试验。 

Inclusion criteria

1.Had chronic urinary retention caused by lower motor neuron damage caused by injury of sacral plexus, cauda equina and sacral spinal cord, pelvic floor nerve lesion after pelvic surgery and peripheral neuropathy due to diabetes. 2.Aged more than 18 years; 3.Duration of disease was more than 3 months. 4.Had postvoid residual urine volume 300 mL or more and sensation of bladder. 5.CIC or transurethral bladder indwelling catheterization. 6.Had at least 4 weeks of treatment and had one record of assessment after treatment. 7.Signed informed consent and participated in the study voluntarily. 

排除标准:

1.膀胱出口梗阻(膀胱颈挛缩、尿道狭窄或前列腺癌、前列腺增生等)导致的尿潴留(注:良性前列腺增生如没有明显导致膀胱出口梗阻,既使有前列腺增生也可纳入); 2.患有泌尿系统肿瘤或结石; 3.其他非下运动神经源性的逼尿肌无力; 4.合并胸髓、颈髓及脑病变或损伤所致的二便障碍; 5.耻骨上膀胱造瘘术后; 6.严重心、肝、肾、精神疾病或凝血功能障碍患者; 7.安置心脏起搏器,或已经植入骶神经刺激电极、阴部神经刺激电极,或膀胱内刺激电极患者; 8.妊娠或哺乳期患者. 

Exclusion criteria:

1.Had urinary retention due to bladder outlet obstruction (bladder neck contracture, urethral stricture, prostate cancer, prostatic hyperplasia, etc.) 2.Had urinary system tumors or stones, urinary disorder due to lesions or injuries of thoracic spinal cord, cervical spinal cord and brain; 3.Detrusor underactivity caused by lesion of non-lower motor neuron; 4.Comorbidities of baldder and bowel dysfunction caused by lesion of thoracic cord, cervical cord and brain; 5.Had suprapubic cystostomy; 6.Had severe heart, liver, kidney, mental disorders or coagulation disorders; 7.Had been implanted a cardiac pacemaker, sacral nerve stimulation electrode, pudendal nerve stimulation electrode, or bladder stimulation electrode; 8.During pregnancy or in lactation. 

研究实施时间:

Study execute time:

From2016-12-01To 2018-09-30 

干预措施:

Interventions:

组别:

电针组

样本量:

30

Group:

Electroacupuncture group

Sample size:

干预措施:

电针

干预措施代码:

Intervention:

Electroacupuncture

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(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院广安门医院 

单位级别:

中央直属 

Institution
hospital:

Guang’an Men Hospital, China Academy of Chinese Medical Sciences  

Level of the institution:

Directly affiliated to the central government 

测量指标:

Outcomes:

指标中文名:

自主排尿后膀胱残余尿量较基线减少50%及以上的病例数所占百分率

指标类型:

主要指标 

Outcome:

The proportions of participants with a decline of 50% or more from baseline in the PVR volume after spontaneous urination

Type:

Primary indicator 

指标中文名:

满意自主排尿的患者病例数所占百分率

指标类型:

次要指标 

Outcome:

The proportion of satisfactory spontaneous urination responders

Type:

Secondary indicator 

指标中文名:

残余尿量较基线变化值

指标类型:

次要指标 

Outcome:

The change from baseline of the postvoid residual urine volume after spontaneous urination

Type:

Secondary indicator 

指标中文名:

不同排尿困难程度患者病例数所占百分率

指标类型:

次要指标 

Outcome:

The proportion of patients with different degree of urination difficulty

Type:

Secondary indicator 

指标中文名:

需要尿管导尿的患者病例数所占百分率

指标类型:

次要指标 

Outcome:

The proportion of patients with catheterization

Type:

Secondary indicator 

指标中文名:

需要手法辅助排尿的患者病例数所占百分率

指标类型:

次要指标 

Outcome:

The proportion of patients with assisted bladder emptying

Type:

Secondary indicator 

指标中文名:

大便潴留的患者病例数所占百分率

指标类型:

次要指标 

Outcome:

The proportion of patients with stool retention

Type:

Secondary indicator 

指标中文名:

反复泌尿系感染的发生率

指标类型:

次要指标 

Outcome:

The incidence of recurrent symptomatic urinary tract infection

Type:

Secondary indicator 

指标中文名:

膀胱结石的发生率

指标类型:

次要指标 

Outcome:

The incidence of vesical calculus

Type:

Secondary indicator 

指标中文名:

输尿管积水的发生率

指标类型:

次要指标 

Outcome:

The incidence of hydroureter

Type:

Secondary indicator 

指标中文名:

肾积水的发生率

指标类型:

次要指标 

Outcome:

The incidence of hydronephrosis

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

不涉及

组织:

Sample Name:

NA

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 82 years

随机方法(请说明由何人用什么方法产生随机序列):

不涉及

性别:

男女均可

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

NA

Gender:

Both

盲法:

Blinding:

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):

研究的数据将公开发表在同行审阅的杂志上。Resman平台。

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

The data of this study will be disseminated by its publication of the manuscript in a peer-reviewed journal. Resman平台。

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):

受试者的个人隐私将在法律允许的范围内得到严格保密。伦理委员会和管理当局应被准予在不违反适用法律和法规所准许的范围内,在不侵犯受试者的隐私的情况下,直接查阅受试者的原始医疗记录。

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

All the information related to participants in this study was kept confidentially. Only clinical research institutes, and ethics committees may have access to the medical records.

创建人:

Creater Name:

 2018-12-03
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