ChiCTR2600123650 版本V1.0 版本创建时间2026/04/28 15:56:11 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：

 ChiCTR2600123650 

最近更新日期：

Date of Last Refreshed on：

 2026-04-28 15:55:56 

注册时间：

Date of Registration：

 2026-04-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

试行难治性CP/CPPS的补充护理认证和转诊途径：基于医院的混合方法现实世界研究方案

Public title：

Piloting a supplemental care certification and referral pathway for refractory CP/CPPS: a hospital-based mixed-methods real-world study protocol

注册题目简写：

English Acronym：

研究课题的正式科学名称：

难治性慢性前列腺炎/慢性骨盆疼痛综合征补充治疗认证与转诊路径的试点研究

Scientific title：

A pilot study on supplementary treatment accreditation and referral pathways for refractory chronic prostatitis/chronic pelvic pain syndrome

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：

胡忠良 

研究负责人：

胡忠良 

Applicant：

Zhongliang Hu 

Study leader：

Zhongliang Hu 

申请注册联系人电话：

Applicant telephone：

 +86 180 9463 7777

研究负责人电话：

Study leader's
telephone：

+86 180 9463 7777

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：

 525540860@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 525540860@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：

哈尔滨市松北区江都街209号

研究负责人通讯地址：

哈尔滨市松北区江都街209号

Applicant address：

209 Jiangdu Street, Songbei District, Harbin

Study leader's address：

209 Jiangdu Street, Songbei District, Harbin

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：

黑龙江省第二医院

Applicant's institution：

the 2nd Hospital of Heilongjiang Province

研究负责人所在单位：

黑龙江省第二医院

Affiliation of the Leader：

the 2nd Hospital of Heilongjiang Province

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：

 学术评审2026第(017)号

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：

黑龙江省第二医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Hospital of Heilongjiang Province

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-20 00:00:00

伦理委员会联系人：

胡英华

Contact Name of the ethic committee：

Yinghua Hu

伦理委员会联系地址：

黑龙江省第二医院8号楼325小会议室

Contact Address of the ethic committee：

Small Conference Room 325, Building 8, the Second Hospital of Heilongjiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 180 9463 7777

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：

黑龙江省第二医院

Primary sponsor：

the 2nd Hospital of Heilongjiang Province

研究实施负责（组长）单位地址：

哈尔滨市松北区江都街209号

Primary sponsor's address：

209 Jiangdu Street, Songbei District, Harbin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

黑龙江省

市(区县)：

哈尔滨市

Country：

China

Province：

Heilongjiang Province

City：

Harbin

单位(医院)：

黑龙江省第二医院

具体地址：

哈尔滨市松北区江都街209号

Institution
hospital：

the 2nd Hospital of Heilongjiang Province

Address：

209 Jiangdu Street, Songbei District, Harbin

经费或物资来源：

中国国家自然科学基金会 82572899

Source(s) of funding：

National Natural Science Foundation of China 82572899

研究疾病：

难治性慢性前列腺炎/慢性骨盆疼痛综合征  

Target disease：

Chronic Prostatitis/Chronic Pelvic Pain Syndrome

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：

单臂 

Study design：

Single arm 

研究目的：

核心目的在于评价该创新转诊模式能否有效减轻三级医院专科门诊的接诊压力，降低非急诊泌尿外科门诊的重复就诊频率（系统级指标）；同时改善患者的疾病负担，量化体现为美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）总分的临床意义下降（临床级指标）。  

Objectives of Study：

The core objective is to evaluate whether this innovative referral model can effectively alleviate the reception pressure of specialized outpatient departments in tertiary hospitals and reduce the frequency of repeated visits to non-emergency urology outpatient departments (system-level indicators). At the same time, it improves the disease burden of patients, which is quantified as a decrease in the clinical significance of the total score of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (a clinical-grade indicator).

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.人口统计学要求：生物学性别为男性，实际年龄严格限制在18岁（含）至60岁（含）之间。 2.核心诊断与病程底线：必须由黑龙江省第二医院作为核心诊断中心的主治及以上级别医师，依据病史及检查明确下达CP/CPPS（即NIH分类中的III型前列腺炎）的官方诊断，且病历资料能够清晰证实该疾病的确诊时间已达或超过6个月。 3.难治性”临床状态的量化界定：在研究筛选日之前的连续12个月内，患者在三级公立医院的泌尿外科门诊拥有至少5次及以上的登记就诊记录，且伴随患者在主诉中明确表示或历史病历记录支持，经过这段时期的高频反复就诊及常规药物治疗，其核心临床症状并未获得任何具有实质意义的改善或缓解。 4.疾病严重程度阈值：在基线（T0）评估阶段，受试者完成的美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）评估总分必须大于15分。 5.知情同意：患者具备完全的民事行为能力，能够充分理解本研究的目的、流程、潜在获益与可能付出的成本，并自愿在具备法律效力的《受试者知情同意书》上郑重签字确认。

Inclusion criteria

1. Demographic requirements: Biological sex must be male, and actual age is strictly limited to between 18 years (inclusive) and 60 years (inclusive). 2. Core diagnosis and disease course baseline: The official diagnosis of CP/CPPS (i.e., type III prostatitis in the NIH classification) must be clearly issued by a physician at the attending level or above from the Second Hospital of Heilongjiang Province as the core diagnostic center, based on medical history and examinations, and the medical records must clearly confirm that the diagnosis has been established for at least 6 months. 3. Quantitative definition of 'refractory' clinical status: During the continuous 12 months before the study screening day, the patient must have at least 5 registered outpatient visits to the urology department of a tertiary public hospital, and the patient’s complaints or historical medical records must confirm that despite this period of frequent repeated visits and conventional drug treatment, the core clinical symptoms have not achieved any substantive improvement or relief. 4. Disease severity threshold: At the baseline (T0) assessment stage, the total score of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) completed by the subject must be greater than 15 points. 5. Informed consent: The patient must have full civil capacity, be able to fully understand the purpose, procedure, potential benefits, and possible costs of this study, and voluntarily sign the legally effective "Informed Consent Form of the Subject" to confirm consent.

排除标准：

1.潜在的严重器质性病变或红旗征：具体包括但不限于：急性细菌性前列腺炎（I型，伴随高热寒战）、任何类型的泌尿生殖系统恶性肿瘤（如前列腺癌、膀胱癌原位癌等）、泌尿系统结核感染、严重的尿道狭窄导致重度排尿梗阻等 。 2.干预交叉与科学纯洁性破坏：患者当前正在作为受试者，积极参与其他任何针对前列腺炎或盆腔疼痛的药物性临床试验（特别是处于保密期的新药I-III期试验）或器械类临床试验。此项排除旨在绝对防止不同试验干预效应之间的相互重叠、干扰以及可能产生的无法解析的数据混杂。 3.严重的精神心理与认知沟通障碍：患者既往被确诊患有严重的精神性疾病（例如处于急性发作期的重度精神分裂症、双相情感障碍、重度自杀倾向的抑郁症等），或者存在因为脑血管后遗症等导致的严重认知退化、语言表达或理解障碍。

Exclusion criteria：

1. Potential serious organic lesions or red flag signs: Specifically including but not limited to: acute bacterial prostatitis (Type I, accompanied by high fever and chills), any type of genitourinary malignancy (such as prostate cancer, bladder carcinoma in situ, etc.), urinary system tuberculosis infection, severe urethral stricture causing significant urinary obstruction, etc. 2. Intervention crossover and compromise of scientific integrity: Patients are currently enrolled as subjects and actively participating in any other pharmacological clinical trials for prostatitis or pelvic pain (especially new drug Phase I-III trials under confidentiality) or device-related clinical trials. This exclusion is intended to absolutely prevent overlapping, interference, and potentially unresolvable data confounding effects between different trial interventions. 3. Severe psychiatric and cognitive communication disorders: Patients previously diagnosed with severe psychiatric disorders (e.g., acute phase of severe schizophrenia, bipolar disorder, depression with severe suicidal tendencies, etc.), or those with severe cognitive decline, language expression, or comprehension impairments due to sequelae of cerebrovascular accidents, etc.

研究实施时间：

Study execute time：

从 From 2026-03-20 00:00:00至 To 2028-09-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-01 00:00:00 至 To 2027-05-01 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 120

Group：

intervention group

Sample size：

干预措施：

实施一项系统层面的结构性干预，即“认证转诊路径（CRP）”。具体表现为由公立三级医院的多学科专家团队（MDT）通过严格的四步质量控制程序认证地方私立康复机构，随后建立双向闭环的转诊通道，将符合条件的难治性患者导航至这些获得认证的机构，接受耗时较长、非药物主导的多模式联合康复治疗（涵盖盆底物理治疗与心理认知行为干预等）。

干预措施代码：

Intervention：

Implement a system-level structural intervention, namely "Certified Referral Pathway (CRP)". Specifically, the multi-disciplinary expert team (MDT) of public tertiary hospitals certifies local private rehabilitation institutions through a strict four-step quality control procedure. Subsequently, a two-way closed-loop referral channel is established to guide eligible refractory patients to these certified institutions. Receive time-consuming, non-drug-led multimodal combined rehabilitation treatment (including pelvic floor physical therapy and psychological cognitive behavioral intervention, etc.).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 黑龙江省 

市(区县)：

 哈尔滨 

Country：

China

Province：

Heilongjiang Province

City：

Harbin

单位(医院)：

 黑龙江省第二医院 

单位级别：

 三甲 

Institution
hospital：

the 2nd Hospital of Heilongjiang Province

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

泌尿外科门诊就诊频率

指标类型：

主要指标

Outcome：

Frequency of outpatient visits to the urology department

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

NIH-CPSI 总分

指标类型：

主要指标

Outcome：

NIH-CPSI 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：

GAD-7与 PHQ-9

指标类型：

次要指标

Outcome：

GAD-7 PHQ-9

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量（QoL）

指标类型：

次要指标

Outcome：

QoL

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

CSQ-8 客户满意度问卷与 NPS（净推荐值）

指标类型：

次要指标

Outcome：

CSQ-8 and NPS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

公立及私立医疗支出、患者自付费用及交通成本

指标类型：

次要指标

Outcome：

Public and private medical expenditures, patient out-of-pocket expenses and transportation costs

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：

无

组织：

Sample Name：

none

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

根据《临床试验计划书模板》，干预效果评价研究通常需说明随机序列生成及分组隐蔽流程，以减少选择性偏倚。但本研究为单臂前瞻性真实世界设计（Single-arm, prospective RWE），无平行对照，因此不涉及传统的随机化与分组隐蔽程序。 为了尽量防止选择性偏倚，研究在招募阶段采用连续病例纳入法（Consecutive Sampling）。专职临床研究协调员（CRC）定期通过医院信息系统（HIS）运行预设算法，提取过去 12 个月内 CP/CPPS 高频就诊（≥5 次）的患者名单。在每日门诊中，接诊专家严格按照名单和就诊顺序，逐一邀请符合纳入标准的患者参与研究，直至锁定 120 例完成知情同意。该连续、无主观筛选的纳入策略最大程度保持了患者群体的真实分布特征。

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

According to the "Clinical Trial Protocol Template", intervention effect evaluation studies usually need to explain the generation of random sequences and the covert process of grouping to reduce selective bias. However, this study was a Single-arm prospective RWE design without parallel controls, and thus did not involve the traditional randomization and grouping covert procedures. To minimize selective bias as much as possible, the study adopted continuous case inclusion (Consecutive Sampling) in the recruitment stage. The full-time Clinical Research Coordinator (CRC) regularly runs a preset algorithm through the hospital Information system (HIS) to extract the list of patients with frequent CP/CPPS visits (≥5 times) in the past 12 months. In the daily outpatient service, the attending experts strictly invited patients who met the inclusion criteria to participate in the study one by one in accordance with the list and the order of their visits, until 120 cases were identified and informed consent was completed. This continuous and non-subjective screening inclusion strategy maintains the true distribution characteristics of the patient population to the greatest extent.

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：

评估者盲法

Blinding：

Assessor blinding

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）：

在研究主要结果于同行评议期刊发表后的 6 个月起，针对有合理科学研究需求的独立研究者，在签署数据使用协议并承诺保护患者隐私的前提下，可通过向主要研究者发送电子邮件（525540860@qq.com）请求获取脱敏后的原始数据集。数据共享期限为发表后 3 年内。

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

Starting six months after the main results of the study are published in a peer-reviewed journal, independent researchers with reasonable scientific research needs may request to obtain the desensitized original dataset by sending an email to the principal investigator (525540860@qq.com), provided they have signed a data usage agreement and committed to protecting patient privacy. The data sharing period is within three years from the date of publication.

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：

在本研究中，确保数据真实性、准确性和保密性是核心原则。 1. 数据溯源：所有临床观察和测量结果均首先记录在原始医疗载体中，包括 HIS 系统电子病历、实验室化验单及私立机构手工记录。源数据一经形成，不得擅自修改。 2. 电子数据录入（eCRF）：源数据由授权数据录入员录入电子病例报告表（eCRF），患者自主填写的量表（如 NIH-CPSI、QoL）通过安全移动端上传至中央数据库，实现实时、可追溯的数据记录。 3. 数据核对与权限管理：实施双人独立录入比对和系统自动核验，异常数据触发警示并锁定。数据库访问严格遵循最小权限原则，仅授权经过严格审核的人员访问，并保留完整的时间戳和操作记录（Audit Trail），确保数据不可篡改、可追溯。

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

In this study, ensuring the authenticity, accuracy and confidentiality of the data is the core principle. 1. Data traceability: All clinical observations and measurement results are first recorded in the original medical carrier, including electronic medical records in the HIS system, laboratory test reports, and manual records in private institutions. Once the source data is formed, it shall not be modified without authorization. 2. Electronic Data Entry (eCRF) : The source data is entered into the electronic case Report form (eCRF) by authorized data entry personnel. The scales filled out by patients themselves (such as NIH-CPSI, QoL) are uploaded to the central database through a secure mobile terminal, achieving real-time and traceable data recording. 3. Data verification and permission management: Implement independent data entry and comparison by two people and automatic system verification. Abnormal data triggers warnings and locks. Database access strictly adheres to the principle of least privilege, authorizing only personnel who have passed strict audits to access, and retaining complete timestamps and operation records (Audit Trail) to ensure that the data is immutable and traceable.

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：

  2026-04-28 15:55:56