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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Changes of urinary flora in patients with DO treated with BTX-A injection and its correlation with urinary tract infection

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注册号：

Registration number：

ChiCTR2600126752 

最近更新日期：

Date of Last Refreshed on：

2026-06-15 14:55:28 

注册时间：

Date of Registration：

2026-06-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

BTX-A注射治疗DO患者的尿液菌群变化及与尿路感染的相关性研究

Public title：

Changes of urinary flora in patients with DO treated with BTX-A injection and its correlation with urinary tract infection

注册题目简写：

English Acronym：

研究课题的正式科学名称：

BTX-A注射治疗DO患者的尿液菌群变化及与尿路感染的相关性研究

Scientific title：

Changes of urinary flora in patients with DO treated with BTX-A injection and its correlation with urinary tract infection

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：

廖利民 

研究负责人：

廖利民 

Applicant：

Liao Limin 

Study leader：

Liao Limin 

申请注册联系人电话：

Applicant telephone：

+86 10 87569046

研究负责人电话：

Study leader's telephone：

+86 10 87569043

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：

2571151302@qq.com

研究负责人电子邮件：

Study leader's E-mail：

lmliao@263.net

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：

中国北京市丰台区角门北路10号

研究负责人通讯地址：

中国北京市丰台区角门北路10号

Applicant address：

10 Jiaomen North Road, Fengtai District, Beijing, China

Study leader's address：

10 Jiaomen North Road, Fengtai 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：

中国康复研究中心

Applicant's institution：

China Rehabilitation Research Center

研究负责人所在单位：

中国康复研究中心

Affiliation of the Leader：

China Rehabilitation Research Center

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-049-02

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：

中国康复研究中心医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of China Rehabilitation Research Center

伦理委员会批准日期：

Date of approved by ethic committee：

2025-07-06 00:00:00

伦理委员会联系人：

孟丽君

Contact Name of the ethic committee：

Meng Lijun

伦理委员会联系地址：

中国北京市丰台区角门北路10号

Contact Address of the ethic committee：

10 Jiaomen North Road, Fengtai District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 87020512

伦理委员会联系人邮箱：

Contact email of the ethic committee：

menglydia@126.com

研究实施负责（组长）单位：

中国康复研究中心

Primary sponsor：

China Rehabilitation Research Center

研究实施负责（组长）单位地址：

中国北京市丰台区角门北路10号

Primary sponsor's address：

10 Jiaomen North Road, Fengtai District, Beijing, China

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)：

北京博爱医院

具体地址：

中国北京市丰台区角门北路10号

Institution
hospital：

Beijing Bo'ai Hospital

Address：

10 Jiaomen North Road, Fengtai District, Beijing, China

经费或物资来源：

中央级公益性科研院所基本科研业务费专项资金

Source(s) of funding：

Basic Research Fund of Central Public Welfare Research Institutes

Target disease：

Lower urinary tract disease

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

本课题拟通过探究健康研究参与者与逼尿肌过度活动患者的尿液微生物差异、A型肉毒毒素注射、肠道膀胱扩大术治疗逼尿肌过度活动患者的尿液菌群变化以及其与尿路感染的相关性，从微生物组学角度分析逼尿肌过度活动、尿路感染发生的原因，探索其机制，并将是否发生过尿路感染与A型肉毒毒素注射后疗效相关联，进而为降低尿路感染的发生率、提高A型肉毒毒素注射后疗效奠定基础。  

Objectives of Study：

This study intends to explore the differences in urinary microbiota between healthy research participants and patients with detrusor overactivity, as well as the alterations of urinary flora in detrusor overactivity patients treated with botulinum toxin type A injection and enterocystoplasty, and their correlation with urinary tract infection. From the perspective of microbiomics, it analyzes the etiology and mechanism underlying the occurrence of detrusor overactivity and urinary tract infection. Meanwhile, it correlates the history of urinary tract infection with the therapeutic efficacy after botulinum toxin type A injection, thereby laying a foundation for reducing the incidence of urinary tract infection and improving the curative effect of botulinum toxin type A injection.

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.健康研究参与者： （1）年龄18-75岁，性别不限 （2）研究参与者签署书面知情同意书 （3）无尿失禁史和其他泌尿系统疾病史；
2.BTX-A注射： （1）年龄18-75岁，性别不限 （2）研究参与者签署书面知情同意书 （3）保守治疗无效或不能耐受M受体阳断剂等药物不良反应、膀胱壁尚未严重纤维化、能接受间歇导尿的神经源性逼尿肌过度活动患者 （4）保守治疗无效或不能耐受M受体阻断剂等药物不良反应的难治性膀胱过度活动症患者 （5）保守治疗无效的逼尿肌-括约肌协同失调、逼尿肌活动低下、尿道内括约肌（膀胱颈）松弛障碍或痉挛的患者,或者不接受及不适合间歇导尿的患者 （6）保守治疗无效或不能耐受药物不良反应的间质性膀胱炎/膀胱疼痛综合征患者；
3.肠道膀胱扩大术： （1）年龄18-75岁，性别不限 （2）研究参与者签署书面知情同意书 （3）经抗胆碱能药物、BTX-A逼尿肌注射及神经调控治疗后无效 （4）储尿期膀胱高压（＞40 cmH2O）或膀胱顺应性降低（＜10 ml/cmH2O）伴有或不伴有上尿路损害 （5）高级别和/或低压膀胱输尿管反流伴上尿路损害 （6）重度上尿路扩张伴输尿管膀胱结合部狭窄 （7）某些感染和炎症性疾病导致的膀胱挛缩，如结核病；

Inclusion criteria

1.Healthy research participants: (1) Aged 18 to 75 years, regardless of gender; (2) All research participants have signed the written informed consent form; (3) No history of urinary incontinence or other urinary system diseases.
2.BTX-A injection: (1) Aged 18 to 75 years, regardless of gender; (2) All research participants have signed the written informed consent form; (3) Patients with neurogenic detrusor overactivity who are refractory to conservative treatment, or cannot tolerate the adverse reactions of drugs such as M-receptor blockers, with no severe bladder wall fibrosis, and able to accept intermittent catheterization; (4) Patients with refractory overactive bladder who are refractory to conservative treatment or cannot tolerate the adverse reactions of drugs such as M-receptor blockers; (5) Patients with detrusor-sphincter dyssynergia, detrusor underactivity, internal urethral sphincter (bladder neck) relaxation disorder or spasm who are refractory to conservative treatment, or who refuse or are not suitable for intermittent catheterization; (6) Patients with interstitial cystitis/bladder pain syndrome who are refractory to conservative treatment or cannot tolerate drug adverse reactions.
3.Enterocystoplasty (1) Aged 18–75 years, with no restriction on gender. (2) All research participants have signed the written informed consent. (3) Intractable condition after failure of anticholinergic medication, detrusor injection of botulinum toxin type A (BTX-A), and neuromodulation therapy. (4) High bladder pressure during the storage phase (> 40 cmH₂O) or decreased bladder compliance (< 10 ml/cmH₂O), with or without upper urinary tract damage. (5) High-grade and/or low-pressure vesicoureteral reflux complicated with upper urinary tract damage. (6) Severe upper urinary tract dilatation accompanied by ureterovesical junction stricture. (7) Bladder contracture caused by certain infectious and inflammatory diseases, such as tuberculosis.

排除标准：

1.健康研究参与者：（1）尿路感染、阴道感染（2）入组近1个月内使用过抗生素、抗菌药物等（3）糖尿病、肥胖症等代谢性疾病（4）妊娠、哺乳期和生理期期间（5）其他；
2.BTX-A注射： （1）孕妇、哺乳期妇女、研究期间计划受孕的育龄妇女 （2）已知对研究药物及其成份过敏者，或过敏体质者 （3）伴有临床不稳定的严重心血管疾病 （4）肾功能不全 （5）肝脏疾病者 （6）酗酒或药物滥用者 （7）入组前1个月内参加其他药物临床试验 （8）入组前6个月接受过任何BTX制剂治疗者 （9）泌尿系感染 （10）伴膀胱结石、输尿管结石或尿道结石者 （11）膀胱癌或前列腺癌患者 （12）伴糖尿病 （13）近1周内使用过氨基糖苷类抗生素或神经肌肉接点功能药物者 （14）任何可能在使用BTX-A时风险升高的医疗情况 （15）有出血倾向者 （16）1周内使用过抗凝制剂者 （17）其他；
3.肠道膀胱扩大术： （1）肠道疾病或功能障碍：包括炎症性肠病（克隆恩病、放射性肠病等）、短肠综合征、肠梗阻、肠粘连严重、肠缺血、肠道肿瘤等 （2）泌尿系感染 （3）凝血功能障碍 （4）肾功能、肝功能、心功能衰竭等重要器官功能不全 （5）膀胱严重纤维化或瘢痕化 （6）妊娠或哺乳期 （7）其他；

Exclusion criteria：

1.Healthy Research Participants: (1) Urinary tract infection, vaginal infection; (2) Those who used antibiotics, antibacterial drugs, etc. within nearly 1 month before enrollment; (3) Metabolic diseases such as diabetes mellitus and obesity; (4) During pregnancy, lactation period and menstrual period; (5) Others.
2.BTX-A: (1) Pregnant women, lactating women, and women of childbearing age planning to become pregnant during the study period; (2) Those with known allergies to the study drug and its components, or those with allergic diathesis; (3) Complicated with clinically unstable severe cardiovascular diseases; (4) Renal insufficiency; (5) Those with liver diseases; (6) Alcoholics or drug abusers; (7) Participants who participated in other drug clinical trials within 1 month before enrollment; (8) Those who received any BTX preparation treatment within 6 months before enrollment; (9) Urinary tract infection; (10) Those with bladder stones, ureteral stones or urethral stones; (11) Patients with bladder cancer or prostate cancer; (12) Complicated with diabetes mellitus; (13) Those who used aminoglycoside antibiotics or neuromuscular junction function drugs within the past 1 week; (14) Any medical condition that may increase the risk when using BTX-A; (15) Those with bleeding tendency; (16) Those who used anticoagulant preparations within 1 week; (17) Others.
3.Enterocystoplasty: (1) Intestinal diseases or dysfunctions: including inflammatory bowel disease (Crohn's disease, radiation enteritis, etc.), short bowel syndrome, intestinal obstruction, severe intestinal adhesion, intestinal ischemia, intestinal tumors, etc.; (2) Urinary tract infection; (3) Coagulopathy; (4) Impairment of important organ functions such as renal failure, liver failure, and heart failure; (5) Severe bladder fibrosis or scarring; (6) Pregnancy or lactation period; (7) Others.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2027-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-20 00:00:00 至 To 2027-03-01 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

N/A

Intervention code：

组别：

试验组

样本量：

60

Group：

Experimental group

Sample size：

干预措施：

A型肉毒毒素注射、肠道膀胱扩大术

干预措施代码：

Intervention：

Injection of botulinum toxin type A, augmentation enterocystoplasty

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)：

北京博爱医院 

单位级别：

三级甲等 

Institution
hospital：

Beijing Bo'ai Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

尿液代谢组学

指标类型：

主要指标

Outcome：

Urine metabolomics

Type：

Primary indicator

测量时间点：

术前、术后1、3、6个月

测量方法：

代谢组学分析

Measure time point of outcome：

Preoperatively and at 1, 3, and 6 months postoperatively

Measure method：

Metabolomics Analysis

指标中文名：

尿液微生物

指标类型：

主要指标

Outcome：

Urinary Microbiota

Type：

Primary indicator

测量时间点：

术前、术后1、3、6个月

测量方法：

16S rRNA微生物多样性检测

Measure time point of outcome：

Preoperatively and at 1, 3, and 6 months postoperatively

Measure method：

16S rRNA Microbial Diversity Detection

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

尿液样本

组织：

Sample Name：

Urine sample

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

无

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

None

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

无

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

N/A

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：

建立尿液微生物和代谢组资料库

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

Establish a database of urinary microbiome and metabolome

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-15 14:55:04
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