International Traditional Medicine Clinical Trial Registry

注册号： Registration number：	ITMCTR2024000151
最近更新日期： Date of Last Refreshed on：	2024-08-01
注册时间： Date of Registration：	2024-08-01
注册号状态： Registration Status：	预注册 Prospective registration
注册题目：	电针治疗女性SUI患者的盆底肌功能评价及基于SDF-1/CXCR4通路探讨电针对SUI盆底肌损伤的修复机制
Public title：	Evaluation of pelvic floor muscle function in female SUI patients treated with electroacupuncture and exploration of the repair mechanism of electroacupuncture on SUI pelvic floor muscle injury based on SDF-1/CXCR4 pathway
注册题目简写：
English Acronym：
研究课题的正式科学名称：	电针治疗女性SUI患者的盆底肌功能评价及基于SDF-1/CXCR4通路探讨电针对SUI盆底肌损伤的修复机制
Scientific title：	Evaluation of pelvic floor muscle function in female SUI patients treated with electroacupuncture and exploration of the repair mechanism of electroacupuncture on SUI pelvic floor muscle injury based on SDF-1/CXCR4 pathway
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：	明树人	研究负责人：	明树人
Applicant：	Shuren Ming	Study leader：	Shuren Ming
申请注册联系人电话： Applicant telephone：	+86 131 2075 2968	研究负责人电话： Study leader's telephone：	+86 131 2075 2968
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：	mingshuren@126.com	研究负责人电子邮件： Study leader's E-mail：	mingshuren@126.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：	上海市虹口区甘河路110号	研究负责人通讯地址：	上海市虹口区甘河路110号
Applicant address：	110 Ganhe Road, Hongkou District, Shanghai	Study leader's address：	110 Ganhe Road, Hongkou District, 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 Chinese Medicine

是否获伦理委员会批准： Approved by ethic committee：	是 Yes
伦理委员会批件文号： Approved No. of ethic committee：	2024-039	伦理委员会批件附件： Approved file of Ethical Committee：	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：	Ethics Committee 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：	2024/4/11 0:00:00
伦理委员会联系人：	殷从全
Contact Name of the ethic committee：	Congquan Yin
伦理委员会联系地址：	上海市虹口区甘河路110号
Contact Address of the ethic committee：	110 Ganhe Road, Hongkou District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 021 6516 1782	伦理委员会联系人邮箱： Contact email of the ethic committee：	yyyyllwyh@163.com
国家药监局批准文号： Approved No. of MPA：		国家药监局批准附件： Approved file of MPA：
国家药监局批准日期： Date of approved by MPA：
研究方案： Study protocol：
知情同意书： Informed consent file：

Primary sponsor：

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

Primary sponsor's address：

110 Ganhe Road, Hongkou District, Shanghai

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

Source(s) of funding：

none

研究疾病：	压力性尿失禁	研究疾病代码：
Target disease：	Stress urinary incontinence	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：	其它 Others
研究目的：	通过随机、对照、单盲的临床研究方法，以女性轻中度压力性尿失禁患者1h尿垫试验减少值、盆底肌肌电图、72h尿失禁次数、ICIQ-SF量表、尿失禁漏尿程度、患者主观疗效评价、尿失禁程度的相关性、平均1周尿垫使用量作为观察指标，观察和评价电针对女性SUI患者盆底肌的影响，为针刺治疗 SUI 的临床研究提供科学、客观证据。
Objectives of Study：	Through a randomized, controlled, and single blind clinical research method, the effect of electroacupuncture on the pelvic floor muscles of female patients with mild to moderate stress urinary incontinence was observed and evaluated using indicators such as the decrease in 1-hour urinary pad test, electromyography, 72 hour urinary incontinence frequency, ICIQ-SF scale, degree of urinary incontinence leakage, subjective efficacy evaluation of patients, correlation between urinary incontinence severity, and average 1-week urinary pad usage. This study provides scientific and objective evidence for the clinical research of acupuncture treatment for SUI.
药物成份或治疗方案详述：	1.电针组取穴：中极、关元和大赫（双侧）｡定位：参照《中华人民共和国国家标准·经穴名称与定位》〔GB/T 12346-2021〕（2021年）：中极：在下腹部，脐中下4寸，前正中线上。关元：在下腹部，脐中下3寸，前正中线上。大赫：在下腹部，脐中下4寸，前正中线旁开0.5寸。操作方法：嘱患者排小便后取仰卧位，针刺中极、关元、大赫穴时，使用0.30×75mm毫针以30～45°角斜刺破垫片，透皮40～50mm，均匀提插捻转达到局部酸麻胀得气感，使针感传持续传至膀胱、会阴及尿道部位。然后左侧大赫穴和中极穴接通连续波电针治疗，右侧大赫穴和关元穴接通连续波电针治疗，频率设置为50Hz，电流强度为1mA~5mA，逐渐增大电流强度以患者舒适为度。疗程：每次治疗30分钟，每周3次（隔日1次），连续治疗6周，共治疗18次。 2.安慰电针组取穴：中极、关元和大赫（双侧）｡定位：同电针组。操作方法：嘱患者排小便后取仰卧位，针刺中极、关元、大赫穴时，使用0.25×25mm钝头针以30～45°角斜刺进垫片，接触患者皮肤后停止，不刺入患者体内。然后左侧大赫穴和中极穴接通、右侧大赫穴和关元穴接通连续波电针治疗，剪断电线内部导线，但电线外观同电针组，频率设置为50Hz，电流强度为1mA~5mA，但实际没有通电。疗程：每次治疗30分钟，每周3次（隔日1次），连续治疗6周，共治疗18次。
Description for medicine or protocol of treatment in detail：	1. Electroacupuncture group Acupoint selection: Zhongji, Guanyuan, and Dahe (bilateral) Positioning: Referring to the "National Standard of the People's Republic of China - Names and Positioning of Acupuncture Points" [GB/T 12346-2021] (2021): Mid pole: located in the lower abdomen, 4 inches below the navel, on the anterior midline. Guan Yuan: In the lower abdomen, 3 inches below the navel, on the anterior midline. Dahe: It is located in the lower abdomen, 4 inches below the navel, and 0.5 inches apart from the midline. Operation method: After instructing the patient to urinate, the patient should be placed in a supine position. When needling the Zhongji, Guanyuan, and Dahe acupoints, a 0.30 × 75mm needle should be used to diagonally pierce the gasket at an angle of 30-45 degrees, penetrating the skin by 40-50mm. The needle should be evenly inserted and twisted to achieve a local tingling sensation, allowing the needle sensation to continue to spread to the bladder, perineum, and urethra. Then, continuous wave electroacupuncture treatment was applied to the left Dahe and Zhongji acupoints, and continuous wave electroacupuncture treatment was applied to the right Dahe and Guanyuan acupoints. The frequency was set to 50Hz and the current intensity was 1mA~5mA, gradually increasing the current intensity to ensure patient comfort. Course of treatment: 30 minutes each time, 3 times a week (once every other day), continuous treatment for 6 weeks, a total of 18 treatments. 2. Comfort the electroacupuncture group Acupoint selection: Zhongji, Guanyuan, and Dahe (bilateral) Positioning: Same as the electroacupuncture group. Operation method: After instructing the patient to urinate, place them in a supine position. When needling the Zhongji, Guanyuan, and Dahe acupoints, use a 0.25 × 25mm blunt needle to diagonally insert the pad at a 30-45 ° angle. Stop after touching the patient's skin and do not insert into the patient's body. Then the left Dahe point and Zhongji point were connected, and the right Dahe point and Guanyuan point were connected for continuous wave electroacupuncture treatment. The internal wires of the wires were cut, but the appearance of the wires was the same as that of the electroacupuncture group, with a frequency set at 50Hz and a current intensity of 1mA~5mA, but they were not actually electrified. Course of treatment: 30 minutes each time, 3 times a week (once every other day), continuous treatment for 6 weeks, a total of 18 treatments.
纳入标准：	(1)符合轻、中度女性压力性尿失禁西医诊断标准； (2)年龄≥40岁且≤75岁； (3)理解、同意参加本研究并签署知情同意书。
Inclusion criteria	(1) Meets the Western diagnostic criteria for mild to moderate female stress urinary incontinence; (2) Age ≥ 40 years old and ≤ 75 years old; (3) Understand and agree to participate in this study and sign the informed consent form.
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SUI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； (11)安装心脏起搏器，金属过敏或严重惧针者。 (12)既往接受过针灸治疗的患者。
Exclusion criteria：	(1) Urgent urinary incontinence, mixed urinary incontinence, and overflow urinary incontinence, etc; (2) History of surgical treatment for urinary incontinence or pelvic floor surgery; (3) Genital prolapse ≥ 2 degrees; (4) Symptomatic urinary tract infection; (5) Residual urine>30ml; (6) The maximum urinary flow rate is less than 20ml/s. (7) People who cannot or are restricted from walking, going up and down stairs, or running; (8) Those who have been using drugs that may affect bladder function or are currently receiving SUI specialist treatment; (9) Patients with severe heart, brain, liver, kidney, hematopoietic system and mental disease, diabetes, multiple system atrophy, cauda equina nerve lesion, and myelopathy; (10) Pregnancy or lactation period; (11) Install a pacemaker for individuals with metal allergies or severe fear of needles. (12) Patients who have received acupuncture and moxibustion treatment in the past.
研究实施时间： Study execute time：	从From 2024-02-05 至To 2025-05-31	征募观察对象时间： Recruiting time：	从From 2024-08-05 至To 2025-05-31

Interventions：

组别：	电针组	样本量：	32
Group：	Electroacupuncture group	Sample size：	32
干预措施：	电针中极、关元和大赫穴	干预措施代码：
Intervention：	Electroacupuncture at Zhongji, Guanyuan and Dahe acupoints	Intervention code：

组别：	安慰电针组	样本量：	32
Group：	Sham-electroacupuncture group	Sample size：	32
干预措施：	安慰电针中极、关元和大赫穴	干预措施代码：
Intervention：	Sham-electroacupuncture at Zhongji, Guanyuan and Dahe acupoints	Intervention code：

Total sample size ： 64

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：	三级甲等
Institution/hospital：	Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine	Level of the institution：	Tertiary A

Outcomes：

指标中文名：	1h尿垫试验漏尿量	指标类型：	主要指标
Outcome：	Urine leakage of 1 hour pad test	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	盆底肌肌电图	指标类型：	次要指标
Outcome：	Electromyography of pelvic floor muscles	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	72h尿失禁漏尿程度	指标类型：	次要指标
Outcome：	Degree of urinary incontinence leakage in 72 hours	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	72h尿失禁次数	指标类型：	次要指标
Outcome：	Frequency of urinary incontinence in 72 hours	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	患者主观疗效评价	指标类型：	次要指标
Outcome：	Evaluation of patients' subjective efficacy	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	平均1周尿垫使用量	指标类型：	次要指标
Outcome：	The average usage of urine pad was 1 week	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	ICIQ-SF量表评分	指标类型：	次要指标
Outcome：	ICIQ-SF scale score	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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：

Not yet recruiting

最小	40	岁
Min age	40	years
最大	75	岁
Max age	75	years

Recruiting status：

Participant age：

Gender：

Female

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

Generate a random number table using Excel, select 200 numbers starting from any row or column of the random number table, remove duplicate values, select the first 64 numbers as random numbers, sort the selected random numbers from 1 to 64, mark numbers 1 to 32 as the electroacupuncture group, and numbers 33 to 64 as the placebo electroacupuncture group. Then sort the random numbers from small to large, copy the random numbers and corresponding groups in order on white paper, seal them in an opaque envelope, and label the envelope cover with numbers 1 to 64 in sequence. Each time a new case is included, open the envelope according to the number on the envelope cover to obtain the grouping group.

Sign the informed consent：

Yes

Length of follow-up (include time point of outcome measure)：

Day(s)

隐蔽分组方法和过程：
Process of allocation concealment：
盲法：
Blinding：
揭盲或破盲原则和方法：
Rules of uncover or ceasing blinding：
统计方法名称：
Statistical method：
试验完成后的统计结果（上传文件）：
Calculated Results ater the Study Completed：
上传试验完成后的统计结果： Statistical results after completion of the test file upload
是否公开试验完成后的统计结果： Calculated Results after the Study Completed(upload file)：	公开 Public
全球唯一识别码： UTN

是否共享原始数据： IPD sharing：	否 No
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）：	2025年5月31日后向研究者联系索取
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Contact the researcher after May 31, 2025
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：	采集：病例记录表；管理：原始数据保存在上海中医药大学附属岳阳中西医结合医院档案室。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Collection:Case Record Form. Management: The original data are kept in the archives of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine.
数据管理委员会： Data Managemen Committee：	暂未确定 Not yet
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):