ChiCTR2500114478 版本V1.0 版本创建时间2025/12/12 14:26:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500114478 

最近更新日期：

Date of Last Refreshed on：

 2025-12-12 14:26:17 

注册时间：

Date of Registration：

 2025-12-12 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

“中枢－外周”神经调控技术治疗脑卒中后神经源性膀胱和盆底功能障碍的临床研究

Public title：

Clinical research on the treatment of neurogenic bladder and pelvic floor dysfunction after stroke with "central-peripheral" neuroregulation technology

注册题目简写：

English Acronym：

研究课题的正式科学名称：

“中枢－外周”神经调控技术治疗脑卒中后神经源性膀胱和盆底功能障碍的临床研究

Scientific title：

Clinical research on the treatment of neurogenic bladder and pelvic floor dysfunction after stroke with "central-peripheral" neuroregulation technology

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：

朱菁 

研究负责人：

刘苏 

Applicant：

JingZhu 

Study leader：

Su Liu 

申请注册联系人电话：

Applicant telephone：

 +86 17826151828

研究负责人电话：

Study leader's
telephone：

+86 513 8116 8128

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：

 2323733490@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 327202278@qq.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：

江苏省南通市崇川区西寺路20号南通大学附属医院

研究负责人通讯地址：

江苏省南通市崇川区西寺路20号

Applicant address：

No. 20, Xisi Road, Chongchuan District, Nantong City, Jiangsu Province

Study leader's address：

No. 20, Xisi Road, Chongchuan District, Nantong City, Jiangsu 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：

南通大学附属医院

Applicant's institution：

Affiliated Hospital of Nantong University

研究负责人所在单位：

南通大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Nantong University

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：

 2025-K194-01

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：

南通大学附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Affiliated Hospital of Nantong University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-29 00:00:00

伦理委员会联系人：

钱佳佳

Contact Name of the ethic committee：

Qian Jiajia

伦理委员会联系地址：

江苏省南通市崇川区西寺路20号

Contact Address of the ethic committee：

No. 20, Xisi Road, Chongchuan District, Nantong City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 513 85052390

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 704244534@qq.com

研究实施负责（组长）单位：

南通大学附属医院

Primary sponsor：

Affiliated Hospital of Nantong University

研究实施负责（组长）单位地址：

江苏省南通市崇川区西寺路20号

Primary sponsor's address：

No. 20, Xisi Road, Chongchuan District, Nantong City, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

南通大学附属医院

具体地址：

江苏省南通市崇川区西寺路20号

Institution
hospital：

Affiliated Hospital of Nantong University

Address：

No. 20, Xisi Road, Chongchuan District, Nantong City, Jiangsu Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic（Self-funded）

研究疾病：

神经源性膀胱；尿潴留；盆底功能障碍性疾病  

Target disease：

Neurogenic bladder； Urinary retention； Pelvic floor dysfunction diseases

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. 探索经颅磁刺激（rTMS）联合外周骶神经磁刺激（rPMS）在脑卒中后NUR患者中的治疗效果，验证“中枢+外周”联合磁刺激治疗策略对促进膀胱功能恢复和提高自主排尿能力的临床疗效。 2.比较单一磁刺激（rTMS或rPMS）与联合磁刺激在改善膀胱残余尿量、膀胱容量、逼尿肌功能、排尿效率等方面的差异；分析磁刺激对盆底肌协同功能、生活质量及康复进程的影响。  

Objectives of Study：

1.To explore the therapeutic effect of transcranial magnetic stimulation (rTMS) combined with peripheral sacral nerve magnetic stimulation (rPMS) in patients with NUR after stroke, and to verify the clinical efficacy of the "central + peripheral" combined magnetic stimulation treatment strategy in promoting the recovery of bladder function and improving the ability of spontaneous urination .2. Compare the differences between single magnetic stimulation (rTMS or rPMS) and combined magnetic stimulation in improving residual urine volume in the bladder, bladder capacity, detrusor muscle function, and urination efficiency; To analyze the influence of magnetic stimulation on the synergistic function of pelvic floor muscles, quality of life and rehabilitation process.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.均符合《中国各类主要脑血管病诊断要点2019版》中关于脑卒中的诊断标准，并经颅脑CT或MRI检查确诊；
2.首次中风且处于亚急性期（病程14天至3个月）；
3.临床诊断为卒中后尿潴留，参照《卒中后神经源性膀胱诊治专家共识》诊断；
4.年龄在18岁到85岁之间；
5.患者能配合检查及治疗，且依从性好；
6.患者及家属自愿参加，并签署知情同意书；

Inclusion criteria

1.The patient met the diagnostic criteria for stroke in the "Key Points for the Diagnosis of Major Cerebrovascular Diseases in China 2019 Edition" and was confirmed by cranial CT or MRI examination; 2.The first stroke and in the subacute stage (with a course of 14 days to 3 months; 3.The clinical diagnosis was post-stroke urinary retention, and it was diagnosed in accordance with the "Expert Consensus on the Diagnosis and Treatment of Neurogenic Bladder After Stroke"; 4.Aged between 18 to 85 years old; 5.The patient can cooperate with the examination and treatment, and has good compliance; 6.Patients and their families voluntarily participated and signed the informed consent form.

排除标准：

1.卒中前因其他原因导致的尿潴留（如泌尿系肿瘤、结石或中重度前列腺增生等）；
2.患有泌尿系严重感染或肾积水等间歇导尿及泌尿系统检查禁忌证；
3.有心、肺、肝、肾损伤等严重疾病，且不能耐受；
4.有严重精神障碍、认知障碍或言语障碍等；
5.体内植入有心脏起搏器或金属内固定物者；
6.磁刺激治疗禁忌症者；
7.病情不稳定者（生命体征不稳定和/或48h内病情有进展）；

Exclusion criteria：

1.Urinary retention caused by other reasons before stroke (such as urinary system tumors, stones or moderate to severe benign prostatic hyperplasia, etc.); 2.Patients with severe urinary tract infections or hydronephrosis and other contraindications for intermittent catheterization and urinary system examination; 3.There are serious diseases such as heart, lung, liver and kidney damage, and they cannot tolerate them; 4.There are severe mental disorders, cognitive disorders or speech disorders, etc; 5.Those with implanted pacemakers or metal internal fixators in their bodies; 6.Patients with contraindications to magnetic stimulation therapy; 7.Patients with unstable conditions (unstable vital signs and/or progression of the disease within 48 hours).

研究实施时间：

Study execute time：

从 From 2025-08-01 00:00:00至 To 2027-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-12 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

常规康复组

样本量：

 20

Group：

Control group

Sample size：

干预措施：

常规康复治疗

干预措施代码：

Intervention：

Conventional rehabilitation therapy

Intervention code：

组别：

中枢+外周联合调控组（rTMS+rPMS组）

样本量：

 20

Group：

Central combined with peripheral regulation group (rTMS+rPMS group)

Sample size：

干预措施：

经颅磁刺激联合外周磁刺激（骶3神经）

干预措施代码：

Intervention：

Transcranial magnetic stimulation combined with Peripheral magnetic stimulation（ sacral 3 nerve）

Intervention code：

组别：

rTMS组

样本量：

 14

Group：

rTMS group

Sample size：

干预措施：

经颅磁刺激

干预措施代码：

Intervention：

Transcranial magnetic stimulation

Intervention code：

组别：

rPMS组

样本量：

 20

Group：

rPMS group

Sample size：

干预措施：

外周磁刺激（骶3神经）

干预措施代码：

Intervention：

Peripheral magnetic stimulation( sacral 3 nerve)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 南通大学附属医院 

单位级别：

 三级甲等 

Institution
hospital：

Affiliated Hospital of Nantong University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

盆底功

指标类型：

次要指标

Outcome：

Pelvic floor function

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

本研究采用Glazer盆底表面肌电评估方案，通过表面肌电电极记录患者在不同肌肉状态下（静息期、快速收缩、持续收缩、疲劳恢复期）的盆底肌活动电位。测量数据通过专用sEMG分析系统进行定量处理，并与对照组及治疗前后数据进行对比。

Measure time point of outcome：

Before and after treatment

Measure method：

This study adopted the Glazer pelvic floor surface electromyography assessment protocol. The pelvic floor muscle activity potentials of patients under different muscle states (resting period, rapid contraction, sustained contraction, and fatigue recovery period) were recorded through surface electromyography electrodes. The measurement data were quantitatively processed by a dedicated sEMG analysis system and compared with the control group and the data before and after treatment.

指标中文名：

生命体征参数

指标类型：

次要指标

Outcome：

Vital sign parameters

Type：

Secondary indicator

测量时间点：

整个治疗全程实时监测

测量方法：

使用血压计，血氧仪监测患者血压、心率、血氧。维持在90–140mmHg（收缩压）/60–90mmHg（舒张压）；心率控制在60–100次/分；血氧饱和度≥95%（SpO?）；呼吸频率为12–20次/分。治疗全程采用实时监测，确保患者在治疗过程中的生命体征稳定，保障治疗安全性与良好耐受性。

Measure time point of outcome：

Real-time monitoring was performed throughout the treatment

Measure method：

Blood pressure monitors and blood oxygen meters are used to monitor the patient's blood pressure, heart rate and blood oxygen. Maintain at 90-140mmHg (systolic blood pressure) /60-90 MMHG (diastolic blood pressure); Keep the heart rate between 60 and 100 beats per minute. Blood oxygen saturation ≥95% (SpO?); The respiratory rate is 12 to 20 breaths per minute. Real-time monitoring is adopted throughout the treatment process to ensure the stability of the patient's vital signs during the treatmen

指标中文名：

生活质量指数

指标类型：

次要指标

Outcome：

Quality of life index

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

该评分工具能够有效反映下尿路功能障碍对生活质量的影响程度，共设7个等级，分别为“非常高兴”（0分）至“非常糟糕”（6分），得分越高表示患者因排尿症状所致的生活困扰程度越大。

Measure time point of outcome：

Before and after treatment

Measure method：

This scoring tool can effectively reflect the extent to which lower urinary tract dysfunction affects the quality of life. It is divided into 7 grades, ranging from "very happy" (0 points) to "very bad" (6 points). The higher the score, the greater the degree of life distress caused by the patient's urination symptoms.

指标中文名：

残余尿量

指标类型：

主要指标

Outcome：

Residual urine volume

Type：

Primary indicator

测量时间点：

治疗前和治疗后

测量方法：

四组入组的患者治疗前，无法完成自主排尿再进行经尿道插入导管导尿的残余尿量，以及治疗结束后的导管导尿残余尿量的记录。PVR升高常提示膀胱收缩功能障碍、逼尿肌低活动或括约肌功能协调障碍，PVR降低提示膀胱排空能力提高，是NUR诊断和疗效判断的关键参数。

Measure time point of outcome：

Before and after treatment

Measure method：

Before treatment, the residual urine volume of the four groups of patients who could not complete autonomous urination and then underwent tranurethral catheterization was recorded, and the residual urine volume of catheter catheterization was recorded after the end of treatment.Increased PVR often indicates bladder contraction dysfunction, detrusor low activity or sphincter dysfunction, while decreased PVR indicates improved bladder emptying capacity, which is a key parameter for NUR diagnosis a

指标中文名：

排尿记录指标

指标类型：

次要指标

Outcome：

Urination record indicators

Type：

Secondary indicator

测量时间点：

治疗前和治疗后连续3天的记录平均值

测量方法：

详细记录治疗前、后连续3天的排尿日记，包括日均导尿次数、日均排尿次数、平均单次排尿量，并取平均值。尿潴留患者导尿次数减少，排尿次数增加，排尿量增多，说明患者症状改善越明显。

Measure time point of outcome：

The average values of the records for three consecutive days before and after treatment

Measure method：

Keep detailed records of urination diaries for three consecutive days before and after treatment, including the average daily catheterization frequency, the average daily urination frequency, and the average single urination volume, and take the average value. Patients with urinary retention have a reduced frequency of catheterization, an increased frequency of urination, and an increased volume of urine, indicating a more obvious improvement in their symptoms.

指标中文名：

最大逼尿肌压力

指标类型：

次要指标

Outcome：

Maximum detrusor pressure

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

使用膀胱压力容量评定系统（江苏苏云医疗器材有限公司，苏械注准20152071443，型号：SY-PY500），主要测定膀胱在充盈与排空过程中的压力－容量曲线，检测患者最大逼尿肌压力。逼尿肌压力的上升可间接反映神经调控的恢复，提示逼尿肌活动增强。

Measure time point of outcome：

Before and after treatment

Measure method：

The bladder pressure and volume assessment system (Jiangsu Suyun Medical Equipment Co., LTD., Su Medical Device Registration No. 20152071443, model: SY-PY500) was used to mainly measure the pressure-volume curve of the bladder during filling and emptying, and detect the maximum detrusor pressure of the patient.The increase in detrusor pressure can indirectly reflect the recovery of neural regulation, suggesting enhanced detrusor activity.

指标中文名：

最大膀胱容量

指标类型：

次要指标

Outcome：

Maximum bladder capacity

Type：

Secondary indicator

测量时间点：

治疗前和治疗后

测量方法：

使用膀胱压力容量评定系统（江苏苏云医疗器材有限公司，苏械注准20152071443，型号：SY-PY500），主要测定膀胱在充盈与排空过程中的压力－容量曲线，检测患者最大膀胱容量。膀胱容量的增加提示膀胱储尿功能改善，是反映磁刺激治疗成效的关键参数之一。

Measure time point of outcome：

Before and after treatment

Measure method：

The bladder pressure and volume assessment system (Jiangsu Suyun Medical Equipment Co., LTD., Su Medical Device Registration No. 20152071443, model: SY-PY500) was used to mainly measure the pressure-volume curve of the bladder during the filling and emptying process and detect the maximum bladder capacity of patients.The increase in bladder capacity indicates an improvement in bladder urine storage function and is one of the key parameters reflecting the effectiveness of magnetic stimulation the

指标中文名：

治疗有效率

指标类型：

次要指标

Outcome：

Effective rate of treatment

Type：

Secondary indicator

测量时间点：

治疗结束后

测量方法：

综合判断患者排尿功能的恢复情况，评判标准如下：治愈：患者可自主排尿，膀胱残余尿量＜50mL；显效：患者可自主排尿，残余尿量在 50–100mL 之间。无效：排尿困难无明显改善，持续依赖导尿，残余尿量＞100mL；总有效率=（治愈人数+显效人数）/总人数×100%。

Measure time point of outcome：

After the treatment is completed

Measure method：

The recovery of the patient's urination function is comprehensively evaluated based on the following criteria: Cure: The patient can urinate independently, and the residual urine volume in the bladder is less than 50mL. Marked effect: The patient can urinate independently, with residual urine volume ranging from 50 to 100mL. Ineffective: No significant improvement in difficulty in urination, continuous reliance on catheterization, residual urine volume > 100mL; The total effective rate = (number

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 18 岁 years
最大 Max age 85 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由朱菁应用SPSS25.0软件产生随机数列

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

A random sequence was generated by Zhu Jing using SPSS25.0 software.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

单盲，对评估者隐藏分组

Blinding：

Single blind study with blinded-evaluators

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）：

本研究已在国家医学研究登记备案信息系统完成备案。所有研究原始数据均通过ResMan临床试验公共管理平台（网址：http://www.medresman.org.cn/）进行录入和管理。本研究于 2027 年 7 月 31日完成，完成后3个月之内（2027年10月31日前），将整理研究数据并上传至数据管理平台（网址http://www.medresman.org.cn/）。

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

The way to share raw data:This study has been registered in the National Medical Research Registration and Filing Information System. All original data of the study were entered and managed through ResMan Clinical Trial Public Management Platform (website: http://www.medresman.org.cn/).This study was completed on July 31, 2027. Within three months after completion (before October 31, 2027), the research data will be collated and uploaded to the data management platform (website: http://www.medresman.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：

1.病例记录表（case record form,CRF）： 提前制定CRF表； 对资料收集者进行培训； 及时、完整地记录患者信息、研究数据； 各类人员分工明确，以科学严谨的态度记录客观情况和反映主观感觉 记录或填写后进行复查，由监督人员进行督查 2.ResMan临床试验公共管理平台（网址：http://www.medresman.org.cn/） 建立完善的数据录入与数据存储，定期检查和校对。

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

1. Case record form (CRF) ：Prepare the CRF form in advance; Train data collectors; Timely and completely record patient information and research data; All kinds of personnel have clear divisions of labor. They record objective situations and reflect subjective feelings with a scientific and rigorous attitude. After recording or filling in, they are rechecked and supervised by supervisory personnel.2. Clinical trials ResMan public management platform (http://www.medresman.org.cn/) to establish the perfect data entry and data storage, regular inspection and calibration.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-12-12 14:26:17