ChiCTR2500112506 版本V1.0 版本创建时间2025/11/14 17:14:38 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：

 ChiCTR2500112506 

最近更新日期：

Date of Last Refreshed on：

 2025-11-14 17:14:22 

注册时间：

Date of Registration：

 2025-11-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

老年尿便失禁智能管理及评估系统的研发与应用—探究数字疗法在下尿路症状/便失禁患者的安全性和有效性的一项前瞻性随机对照研究

Public title：

Development and Application of an Intelligent Management and Assessment System for Urinary and Fecal Incontinence in the Elderly - A Prospective Randomized Controlled Study Investigating the Safety and Efficacy of Digital Therapy in Patients with Lower Urinary Tract Symptoms/Fecal Incontinence

注册题目简写：

English Acronym：

研究课题的正式科学名称：

老年尿便失禁智能管理及评估系统的研发与应用—探究数字疗法在下尿路症状/便失禁患者的安全性和有效性的一项前瞻性随机对照研究

Scientific title：

Development and Application of an Intelligent Management and Assessment System for Urinary and Fecal Incontinence in the Elderly - A Prospective Randomized Controlled Study Investigating the Safety and Efficacy of Digital Therapy in Patients with Lower Urinary Tract Symptoms/Fecal Incontinence

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：

黄浩 

研究负责人：

黄浩 

Applicant：

Huang Hao 

Study leader：

Huang Hao 

申请注册联系人电话：

Applicant telephone：

 +86 150 1322 8615

研究负责人电话：

Study leader's
telephone：

+86 150 1322 8615

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：

 1019056315@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1019056315@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：

广州市海珠区南洲北路60号

研究负责人通讯地址：

广州市海珠区南洲北路60号

Applicant address：

No. 60, Nanzhou North Road, Haizhu District, Guangzhou City

Study leader's address：

No. 60, Nanzhou North Road, Haizhu District, Guangzhou City

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：

中山大学孙逸仙纪念医院

Applicant's institution：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学孙逸仙纪念医院

Affiliation of the Leader：

Sun Yat-sen Memorial Hospital of Sun Yat-sen 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：

 SYSKY-2024-1010-02

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：

中山大学孙逸仙纪念医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-12-02 00:00:00

伦理委员会联系人：

区柳珊、彭珊小

Contact Name of the ethic committee：

Ou Liushan, Peng Shanxiao

伦理委员会联系地址：

广州市越秀区长堤大马路171-181号一方长堤7楼715

Contact Address of the ethic committee：

Room 715, 7th Floor, One Fang Changti, No. 171-181, Changti Avenue, Yuexiu District, Guangzhou City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 8133 2587

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中山大学孙逸仙纪念医院

Primary sponsor：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

广州市海珠区南洲北路60号

Primary sponsor's address：

No. 60, Nanzhou North Road, Haizhu District, Guangzhou City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学孙逸仙纪念医院

具体地址：

广州市海珠区南洲北路60号

Institution
hospital：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Address：

No. 60, Nanzhou North Road, Haizhu District, Guangzhou City

经费或物资来源：

中央财政专项资金

Source(s) of funding：

Central government special funds

研究疾病：

泌尿生殖系统疾病  

Target disease：

Diseases of the urogenital system

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探究数字化全程管理和行为治疗在下尿路症状/便失禁患者症状的改善差异  

Objectives of Study：

To explore the differences in improvement between digital full-process management and behavioral therapy in patients with lower urinary tract symptoms/fecal incontinence

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.出现下尿路症状（尿频：排尿次数≥8 次/天、次均排尿量小于 200ml；夜尿增多：夜尿≥2 次/天；尿失禁；便失禁）; 2.患者年龄＞18 岁; 3.患者熟练使用智能手机，并愿意接受数字化膀胱管理/电子排尿日记; 4.入组后同意在试验期间能够按医嘱复诊/用药; 5.自愿参加此项临床研究，且能签署知情同意书

Inclusion criteria

1. Lower urinary tract symptoms occur( Frequent urination: urinary frequency >= 8 times/day, the average urine output per visit is less than 200ml;Increased nocturia: nocturia >=2 times/day; urinary incontinence; fecal incontinence); 2. The patient is over 18 years old; 3. The patient is proficient in using smartphones and is willing to accept digital bladder management/electronic urination diary; 4. After enrollment, agree to follow doctor's orders for follow-up visits/medication during the trial period; 5. Voluntarily participate in this clinical study and be able to sign the informed consent form

排除标准：

1.依从性差，随访资料缺失的患者; 2.合并有其他专科需治疗的盆腔及相关疾病，如膀胱癌、前列腺癌、宫颈癌等泌 尿生殖系统肿瘤、神经系统肿瘤/损伤、未控制的泌尿系感染等; 3.妊娠、哺乳期妇女、研究期间计划受孕的育龄妇女; 4.存在精神、认知障碍无法完成本次研究者; 5.存在试验药物相关服用禁忌症; 6.研究者认为不宜参加研究的其他健康情况.

Exclusion criteria：

1. Patients with poor compliance and missing follow-up data; 2. There are other specialized diseases that need to be treated in the pelvic cavity and related areas, such as bladder cancer, prostate cancer, cervical cancer, and other tumors of the urogenital system, tumors/injuries of the nervous system, uncontrolled urinary tract infections, etc; 3. Pregnant and lactating women, as well as women of childbearing age who plan to conceive during the study period; 4. Those with mental or cognitive impairments who are unable to complete this study; 5. There are contraindications related to the administration of the trial drug; 6. Other health conditions that the researchers consider unsuitable for participation in the study.

研究实施时间：

Study execute time：

从 From 2025-10-20 00:00:00至 To 2026-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-20 00:00:00 至 To 2026-11-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 72

Group：

Control group

Sample size：

干预措施：

对照组受试者接受常规的行为治疗（包括行为治疗、药物治疗及定期的复查）还需使用小禹膀胱管理系统进行排尿日记记录，于治疗 1 月、3 月、6 月及 12 月进行随访，在每次复查及随访时进行有效性和安全性评估。

干预措施代码：

Intervention：

The subjects in the control group received conventional behavioral therapy (including behavioral therapy, drug therapy and regular follow-up), and were also required to use the Xiaoyu Bladder management system to keep a urination diary. Follow-up was conducted at 1 month, 3 months, 6 months and 12 months of treatment, and the efficacy and safety were evaluated at each follow-up and re-examination.

Intervention code：

组别：

试验组

样本量：

 72

Group：

Experimental group

Sample size：

干预措施：

试验组受试者除继续接受常规治疗护理外，还将接受个性化干预措施——数字化全程管理（小禹膀胱管理系统进行膀胱训练、盆底锻炼实时提醒），于治疗 1月、3 月、6 月及 12 月进行随访，在每次复查及随访时进行有效性和安全性评估。

干预措施代码：

Intervention：

In addition to continuing to receive conventional treatment and care, the subjects in the experimental group will also receive personalized intervention measures - digital full-process management (with the Xiaoyu Bladder Management system providing real-time reminders for bladder training and pelvic floor exercises). Follow-up visits will be conducted at 1 month, 3 months, 6 months, and 12 months of treatment, and the effectiveness and safety will be evaluated at each re-examination and follow-up.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 中山大学孙逸仙纪念医院 

单位级别：

 三甲 

Institution
hospital：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

下尿路症状评分变化

指标类型：

主要指标

Outcome：

Change in lower urinary tract symptom score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

排尿次数

指标类型：

次要指标

Outcome：

Frequency of urination

Type：

Secondary indicator

测量时间点：

测量方法：

参与者自我报告

Measure time point of outcome：

Measure method：

Self-report in bladder diaries

指标中文名：

夜尿次数

指标类型：

次要指标

Outcome：

Nocturia frequency

Type：

Secondary indicator

测量时间点：

测量方法：

参与者自我报告

Measure time point of outcome：

Measure method：

Self-report in bladder diaries

指标中文名：

下尿路症状评分

指标类型：

次要指标

Outcome：

scores of ICIQ-MLUTS, ICIQ-FLUTS

Type：

Secondary indicator

测量时间点：

测量方法：

自我报告

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

布里斯托大便分类

指标类型：

次要指标

Outcome：

Bristol stool classification

Type：

Secondary indicator

测量时间点：

测量方法：

自我报告

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

生活质量调查表得分

指标类型：

次要指标

Outcome：

scores of ICIQ-LUTSQoL

Type：

Secondary indicator

测量时间点：

测量方法：

自我报告

Measure time point of outcome：

Measure method：

Self-report

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

Null

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 19 岁 years
最大 Max age 89 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）：

方法：采用分层区组随机化，按研究中心（如中山大学孙逸仙纪念医院、上海交通大学附属仁济医院等5家分中心）进行分层，确保各中心试验组与对照组比例均衡（1:1）。 工具：试验用软件（小禹膀胱管理系统）工作人员将使用计算机统计软件（R语言）生成随机序列，此工作人员独立于研究者，生成结果密封保存于小禹膀胱管理系统，研究者在不破盲情况下无法知道患者分于哪组。

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

Method: Stratified block randomization was adopted, and stratified by research centers (such as Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Renji Hospital Affiliated to Shanghai Jiao Tong University, etc., 5 sub-centers) to ensure that the ratio of the experimental group to the control group in each center was balanced (1:1). Tool: Experimental software (Xiaoyu Bladder Management System) Staff will use computer statistical software (R language) to generate random sequences. This staff member is independent of the researcher. The generated results are sealed and saved in the Xiaoyu Bladder Management System. The researcher cannot know which group the patient is in without unblinding.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究采用双盲（因试验组与对照组干预措施存在功能差异，系统自动产生随机数后自动分组，研究者无法知道分组情况，结局评估者也无法知道分组情况）。

Blinding：

This study adopted a double-blind approach (due to the functional differences in intervention measures between the experimental group and the control group, the system automatically generated random numbers and then automatically grouped the groups. The researchers were unable to know the grouping situation, and neither could the outcome evaluators).

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

医学研究登记备案信息系统（https://www.medicalresearch.org.cn/login）

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

Medical Research Registration and Filing Information System(https://www.medicalresearch.org.cn/login)

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.病例报告表/电子数据记录 在临床试验中，研究者应当确保将任何观察与发现均正确完整地予以记录，并认真填写病例报告表（CRF）。由于我们膀胱智能管理系统可以直接通过线上形式收集患者信息，我们后期将考虑使用导出的方式方便快捷收集数据。记录至少应当包括： （1）每个受试者相关的病史以及病情进展等医疗记录； （2）记录者的签名以及日期。 2.数据管理（数据的采集形式、数据存储载体：电子/纸质、数据完整性检验、数据库建立方法、数据管理系统、数据质量检测方法、数据锁库的定义等） 临床试验记录作为原始资料，不得随意更改；确需作更改时应当说明理由，签名并注明日期。对显著偏离临床试验方案或者在临床可接受范围以外的数据应当加以核实，由研究者作必要的说明。 临床试验中所有观察到的结果和异常发现，均应及时认真核实、记录，保证数据的可靠性。临床试验的各种结论，必须是来源于受试者原始医疗资料的数据。研究者应保证将数据真实、准确、完整、及时、合法地记入受试者医疗记录和病例报告表（CRF）中。 病例报告表应由具体试验医师认真填写；调查问卷由受试者配合、试验医师填写。每例受试者完成试验（访视）后，应尽快完成病例报告表的填写。试验完成、全部病例报告表填写完成后，经中心主要负责人签名，再按规定程序保存，并送交申办者、试验中心及数据管理员。 试验记录所有项目均需填写，不得空项、漏项（无记录的空格，从左上到右下划单斜线）；病例报告表书写页离开试验中心后，如需更改内容，则必须填写专用的“数据更改表”（由申办者或其代表提供）来修改。研究者将审核通篇“更改表”（包括在指定处签名和注明日期）的完整性、准确性。在病例报告表上做任何更正时只能划中位单横线，旁注改后的数据，由研究者签名并注明日期，不得擦涂、覆盖原始记录。

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

1.Case report form/Electronic data record In clinical trials, researchers should ensure that all observations and findings are recorded correctly and completely, and that the case Report Form (CRF) is filled out carefully. As our bladder intelligent management system can directly collect patient information online, we will consider using the export method in the future to conveniently and quickly collect data. The records shall at least include: (1) Medical records related to the medical history and disease progression of each subject; (2) The signature and date of the recorder. 2. Data Management (Data collection forms, data storage carriers: electronic/paper, data integrity verification, database establishment methods, data management systems, data quality inspection methods, definition of data lock database, etc.) Clinical trial records, as original materials, shall not be altered at will. When changes are indeed necessary, the reasons should be stated, signed and dated. Data that significantly deviate from the clinical trial protocol or are outside the clinically acceptable range should be verified, and the researcher should provide necessary explanations. All the results and abnormal findings observed in clinical trials should be verified and recorded in a timely and careful manner to ensure the reliability of the data. All conclusions of clinical trials must be based on data derived from the original medical records of the subjects. Researchers should ensure that the data is truthfully, accurately, completely, timely and legally recorded in the medical records and case report forms (CRF) of the subjects. The case report form should be filled out carefully by the specific testing physician. The questionnaire was filled out by the subjects in cooperation with the trial physician. After each subject completes the trial (visit), they should complete the case report form as soon as possible. After the completion of the trial and the filling of all case report forms, they shall be signed by the main person in charge of the center, then saved in accordance with the prescribed procedures and delivered to the sponsor, the trial center and the data administrator. All items in the test record must be filled in without any blanks or omissions (for blank Spaces without records, draw a single diagonal line from the top left to the bottom right). After the writing page of the case report form leaves the trial center, if any content needs to be modified, a dedicated "Data Modification Form" (provided by the sponsor or its representative) must be filled out to make the changes. The researcher will review the completeness and accuracy of the entire "Change Form" (including signatures and dates at designated locations). When making any corrections on the case report form, only a median single horizontal line should be drawn, with the modified data noted beside it. The researcher should sign and date it. The original records must not be erased or covered.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-11-14 17:14:22