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注册号：

Registration number：

ITMCTR2024000412

最近更新日期：

Date of Last Refreshed on：

2024-09-11

注册时间：

Date of Registration：

2024-09-11

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

Public title：

Efficacy of acupuncture combined with intermittent catheterization in the treatment of urinary retention after spinal cord injury

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Efficacy of acupuncture combined with intermittent catheterization in the treatment of urinary retention after spinal cord injury

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

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：

研究负责人：

Applicant：

liaojiaquan

Study leader：

liaojiaquan

申请注册联系人电话：

Applicant telephone：

+86 15971769555

研究负责人电话：

Study leader's telephone：

15971769555

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：

283242897@qq.com

研究负责人电子邮件：

Study leader's E-mail：

283242897@qq.com

申请单位网址(自愿提供)：

Study leader's 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：

研究负责人通讯地址：

Applicant address：

No. 178, Aviation Avenue, Enshi City, Hubei Province

Study leader's address：

No. 178, Aviation Avenue, Enshi City, Hubei Province

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：

Applicant's institution：

Enshi Prefecture Central Hospital, Hubei Province

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2024-044-01

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

Name of the ethic committee：

Biomedical Research Ethics Committee of Enshi Tujia and Miao Autonomous Prefecture Central Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/4/2 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

qinkailie

伦理委员会联系地址：

Contact Address of the ethic committee：

No. 178, Aviation Avenue, Enshi City, Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 139 8685 3685

伦理委员会联系人邮箱：

Contact email of the ethic committee：

283242897@qq.com

研究实施负责（组长）单位：

Primary sponsor：

The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

研究实施负责（组长）单位地址：

Primary sponsor's address：

158 Wuyang Avenue, Enshi, Hubei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

china

Province：

hubei

City：

enshi

单位(医院)：

具体地址：

Institution
hospital：

The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

Address：

158 Wuyang Avenue

经费或物资来源：

Source(s) of funding：

none

研究疾病：

研究疾病代码：

Target disease：

Spinal cord injury

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

Objectives of Study：

To explore the efficacy of acupuncture combined with intermittent catheterization in the treatment of urinary retention after spinal cord injury (SCI).

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

All patients underwent personalized intermittent catheterization guided by a bladder volume scanner, performed by the same nurse. The procedure involved measuring the bladder volume every 4 hours, and catheterization was done if the volume exceeded 300 ml. If the volume was between 100-300 ml, the scan was repeated after 2 hours. Acupuncture was administered by the same physician, with specific points targeted before and after catheterization. The observation group received acupuncture alongside catheterization, while the control group received standard acupuncture treatment separately. Acupuncture needles were inserted to a depth of 10-40 mm and retained for 30 minutes.

纳入标准：

Inclusion criteria

(1) Meet the diagnostic criteria of SCI, urinary retention and "occlusion" in traditional Chinese medicine; (2) The degree of spinal cord injury is B, C or D and has passed the spinal shock phase; (3) The patient was indwelled with catheterization and the residual urine volume was > 100ml; (4) Good cognitive function, able to cooperate with intermittent catheterization and acupuncture therapy; (5) Able to complete bladder pressure capacity assessment and electromyography examination; (7) Informed consent signed by the patient or family member.

排除标准：

Exclusion criteria：

(1) Presence of severe urinary tract infection; (2) Urodynamic examination showed obvious organic obstruction of urethral outlet or hyperdetrusor reflexia: (3) Severe cardiovascular and cerebrovascular, chronic renal insufficiency, urinary system stones, history of urinary system surgery and other related underlying diseases; (4) Renal function test showed renal insufficiency before enrollment, and urine routine examination showed hematuria and massive proteinuria; (5) Presence of severe autonomic dysfunction.

研究实施时间：

Study execute time：

从From 2023-12-01

至To      2024-07-30

征募观察对象时间：

Recruiting time：

从From 2024-01-01

至To      2024-07-01

干预措施：

Interventions：

组别：

样本量：

33

Group：

Control group

Sample size：

干预措施：

干预措施代码：

Intervention：

Routine rehabilitation and Intermittent catheterization for 8 weeks

Intervention code：

组别：

样本量：

33

Group：

Observation group

Sample size：

干预措施：

干预措施代码：

Intervention：

Routine rehabilitation and acupuncture with intermittent catheterization for 8 weeks

Intervention code：

样本总量 Total sample size ： 66

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

china

Province：

hubei

City：

单位(医院)：

单位级别：

Institution/hospital：

The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

Level of the institution：

Class 3A

测量指标：

Outcomes：

指标中文名：

指标类型：

次要指标

Outcome：

Quality of life scores

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Urodynamic testing

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Voiding diary

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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

The random numbers of 58 subjects were provided by the statistics department of Shaanxi Tianfang Technology Co., Ltd., and a group of 58 random numbers were randomly generated by the PLAN process of SAS9.4 on the computer according to the ratio of 1:1, and the subjects were randomly divided into two groups.

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

是

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）：

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

http://itmctr.ccebtcm.org.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：

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

In this study, all data will be collected by trained staff, and then the data will be filled in the designed case report form (CRF), the data analyst will apply Epidata to build the database, and the investigator will be responsible for ensuring the completeness, accuracy, and timely recording of the collected data. The data management of this study will be carried out by the Data Department of Xi'an Beilin Pharmaceutical Co., Ltd. in order to ensure the authenticity, integrity, confidentiality and traceability of the clinical trial data. The data manager will construct the CRF according to the study protocol and submit it to the investigator and project related personnel for review and finalisation.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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