ChiCTR2600123539 版本V1.0 版本创建时间2026/04/27 17:28:51 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：

 ChiCTR2600123539 

最近更新日期：

Date of Last Refreshed on：

 2026-04-27 17:28:30 

注册时间：

Date of Registration：

 2026-04-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

尿管球囊不同放置位置对前列腺电切术后康复的随机对照研究

Public title：

A Randomized Controlled Trial on the Effects of Different Urinary Catheter Balloon Placement Sites on Recovery Following Transurethral Resection of the Prostate

注册题目简写：

English Acronym：

研究课题的正式科学名称：

尿管球囊不同放置位置对前列腺电切术后康复的随机对照研究

Scientific title：

A Randomized Controlled Trial on the Effects of Different Urinary Catheter Balloon Placement Sites on Recovery Following Transurethral Resection of the Prostate

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：

刘宏强 

研究负责人：

尚攀峰 

Applicant：

Liu Hongqiang 

Study leader：

Shang Panfeng 

申请注册联系人电话：

Applicant telephone：

 +86 931 894 2469

研究负责人电话：

Study leader's
telephone：

+86 931 894 2469

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：

 liuhq8422@163.com

研究负责人电子邮件：

Study leader's E-mail：

 shangpf@lzu.edu.cn

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：

甘肃省兰州市城关区天水南路222号

研究负责人通讯地址：

甘肃省兰州市城关区萃英门82号

Applicant address：

222 Tianshui South Road, Chengguan District, Lanzhou City, Gansu Province

Study leader's address：

No. 82 Cuiyingmen, Chengguan District, Lanzhou City, Gansu Province

申请注册联系人邮政编码：

Applicant postcode：

 730000

研究负责人邮政编码：

Study leader's postcode：

 730000

申请人所在单位：

兰州大学第二临床医学院

Applicant's institution：

Second Clinical Medical College of Lanzhou University

研究负责人所在单位：

兰州大学第二医院

Affiliation of the Leader：

The Second Hospital of Lanzhou 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：

 2026A-580

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：

兰州大学第二医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Hospital of Lanzhou University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-09 00:00:00

伦理委员会联系人：

任伟

Contact Name of the ethic committee：

Ren Wei

伦理委员会联系地址：

甘肃省兰州市城关区萃英门82号

Contact Address of the ethic committee：

No. 82 Cuiyingmen, Chengguan District, Lanzhou City, Gansu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 931 894 2234

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：

兰州大学第二医院

Primary sponsor：

The Second Hospital of Lanzhou University

研究实施负责（组长）单位地址：

甘肃省兰州市城关区萃英门82号

Primary sponsor's address：

No. 82 Cuiyingmen, Chengguan District, Lanzhou City, Gansu 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)：

甘肃省

市(区县)：

兰州

Country：

China

Province：

Gansu

City：

Lanzhou

单位(医院)：

兰州大学第二医院

具体地址：

甘肃省兰州市城关区萃英门82号

Institution
hospital：

The Second Hospital of Lanzhou University

Address：

No. 82 Cuiyingmen, Chengguan District, Lanzhou City, Gansu Province

经费或物资来源：

无经费来源

Source(s) of funding：

None

研究疾病：

前列腺增生  

Target disease：

Benign prostatic hyperplasia

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：

比较TURP术后尿管球囊放置于前列腺窝（试验组）与放置于膀胱内（对照组）两种方式，对患者术后膀胱痉挛发生率和肉眼血尿持续时间的影响。  

Objectives of Study：

A comparison of the effects of placing a urinary catheter balloon in the prostatic fossa (experimental group) versus in the bladder (control group) following TURP on the incidence of postoperative bladder spasm and the duration of gross hematuria.

药物成份或治疗方案详述：

1. 术前准备 两组患者术前准备完全一致。手术方式标准化：所有TURP手术均由同组经验丰富医师完成，切割范围统一至精阜近端，电切及电凝止血确切，冲洗清除组织碎块后，于手术结束前置入Foley三腔气囊导尿管。 2. 分组干预措施 试验组（前列腺窝组）：向球囊内注入无菌生理盐水 30-40 ml，注水量根据术中对前列腺窝深度的测量决定，确保球囊扩张后完全充填并位于前列腺窝内。注水后轻轻向外回拉尿管，术者感受到阻力时即停止，提示球囊已卡在膀胱颈口与前列腺窝之间，无需额外牵引固定。 对照组（膀胱组）：向球囊内注入无菌生理盐水 20-30 ml。注水后向外轻柔牵拉尿管，使球囊贴附于膀胱颈口，无需牵引固定。 说明：两组球囊注水量的差异基于临床常规操作——试验组需充填前列腺窝，对照组仅需固定于膀胱颈，故注水量不同。 3. 术后管理 膀胱冲洗：两组术后均立即予以室温生理盐水持续膀胱冲洗，冲洗速度根据引流液颜色动态调整（初始速度通常为100-120滴/分，随尿色转清逐步减慢或暂停）。 拔管指征：停止膀胱冲洗后引流液连续 24小时 保持肉眼清亮（淡黄色或淡血性），且患者无发热、无严重血块堵塞表现，方予拔除导尿管。 疼痛管理：术后常规按需给予非甾体抗炎药（如双氯芬酸钠栓剂或口服塞来昔布），详细记录用药种类、剂量及次数。 随访计划：住院期间每日评估膀胱痉挛、疼痛及引流情况；出院后于拔管后24h、72h、1周及术后30天通过门诊或电话完成尿控、并发症及生活质量随访。 

Description for medicine or protocol of treatment in detail：

1. Preoperative Preparation Preoperative preparations were identical for both groups. The surgical procedure was standardized: all TURP procedures were performed by the same team of experienced surgeons; the resection margin was uniformly set at the proximal aspect of the verum montis; hemostasis was achieved through electrocautery and electrocoagulation; after irrigation to remove tissue debris, a Foley three-lumen balloon catheter was inserted prior to the conclusion of the procedure. 2. Group-Specific Interventions Experimental Group (Prostatic Fossa Group): 30–40 mL of sterile saline was injected into the balloon. The volume was determined based on intraoperative measurement of the prostatic fossa depth to ensure that the balloon was fully expanded and positioned within the fossa. After injection, the catheter was gently pulled outward; the procedure was stopped upon feeling resistance, indicating that the balloon was securely positioned between the bladder neck and the prostatic fossa, eliminating the need for additional traction or fixation. Control Group (Bladder Group): Inject 20–30 ml of sterile saline into the balloon. After injection, gently pull the urinary catheter outward to position the balloon against the bladder neck; no additional traction or fixation is required. Note: The difference in the volume of saline injected into the balloons between the two groups is based on standard clinical practice—the experimental group requires filling the prostatic fossa, while the control group only needs to be fixed at the bladder neck, hence the different volumes. 3. Postoperative Management Bladder Irrigation: Both groups received continuous bladder irrigation with room-temperature saline immediately after surgery. The irrigation rate was dynamically adjusted based on the color of the drainage fluid (the initial rate was typically 100–120 drops per minute, gradually slowing or pausing as the urine color cleared). Indications for Catheter Removal: The urinary catheter may be removed only after discontinuation of bladder irrigation, provided that the drainage remains visually clear (pale yellow or slightly bloody) for 24 consecutive hours, and the patient exhibits no fever or signs of severe clot obstruction. Pain management: Postoperatively, nonsteroidal anti-inflammatory drugs (NSAIDs) are routinely administered as needed (e.g., diclofenac sodium suppositories or oral celecoxib). The type, dose, and frequency of medication should be recorded in detail. Follow-up Plan: Assess bladder spasm, pain, and drainage status daily during hospitalization. After discharge, conduct follow-up evaluations regarding urinary control, complications, and quality of life via outpatient visits or telephone at 24 hours, 72 hours, 1 week, and 30 days post-catheter removal. 

纳入标准：

1.年满18周岁的男性患者； 2.病理诊断为良性前列腺增生，符合TURP手术指征； 3.首次接受前列腺手术； 4.术前尿流率、前列腺超声等资料完整； 5.术前尿控正常，无尿失禁史。

Inclusion criteria

1. Male patients aged 18 years or older; 2. Patients with a pathological diagnosis of benign prostatic hyperplasia who meet the criteria for TURP surgery; 3. Patients undergoing prostate surgery for the first time; 4. Patients with complete preoperative data, including urine flow rate and prostate ultrasound results; 5. Patients with normal urinary control prior to surgery and no history of urinary incontinence.

排除标准：

1.经直肠指检或穿刺活检确诊的前列腺癌； 2.神经源性膀胱、尿道狭窄或既往有盆腔放化疗史； 3.合并膀胱结石、膀胱肿瘤需同期手术者； 4.术前长期留置尿管者； 5.严重心、肺、脑疾病无法耐受手术者； 6.长期服用抗凝药物术前无法停药者； 7.研究者认为有不适合参加该试验的任何其他情况。

Exclusion criteria：

1. Prostate cancer confirmed by digital rectal examination or needle biopsy; 2. Neurogenic bladder, urethral stricture, or a history of pelvic radiation or chemotherapy; 3. Concurrent bladder stones or bladder tumors requiring simultaneous surgery; 4. Patients with long-term indwelling urinary catheters prior to surgery; 5. Patients with severe cardiac, pulmonary, or neurological conditions who cannot tolerate surgery; 6. Patients on long-term anticoagulant therapy who cannot discontinue the medication prior to surgery; 7. Any other condition deemed by the investigator to make the patient unsuitable for participation in this trial.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2027-06-01 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：

试验组

样本量：

 75

Group：

experimental group

Sample size：

干预措施：

向球囊内注入30-40ml生理盐水（根据术者对前列腺窝深度的测量，保证球囊完全位于窝内）。轻轻回拉尿管，感到有阻力时停止，表示球囊已卡在膀胱颈口与前列腺窝之间（无需牵引固定）。

干预措施代码：

Intervention：

Inject 30–40 mL of saline into the balloon (based on the surgeon’s measurement of the depth of the prostatic fossa, ensuring that the balloon is completely situated within the fossa). Gently retract the catheter; stop when resistance is felt, indicating that the balloon is secured between the bladder neck and the prostatic fossa (no traction is required for fixation).

Intervention code：

组别：

对照组

样本量：

 75

Group：

control group

Sample size：

干预措施：

向球囊内注入20-30ml生理盐水。向外牵引导尿管使球囊卡住膀胱颈口（无需牵引固定）。

干预措施代码：

Intervention：

Inject 20–30 mL of saline into the balloon. Pull the catheter outward to position the balloon so that it rests against the bladder neck (no need to secure it in place).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 甘肃省 

市(区县)：

 兰州市 

Country：

China

Province：

Gansu

City：

Lanzhou

单位(医院)：

 兰州大学第二医院 

单位级别：

 三甲 

Institution
hospital：

The Second Hospital of Lanzhou University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

膀胱痉挛发生率

指标类型：

主要指标

Outcome：

Incidence of bladder spasms

Type：

Primary indicator

测量时间点：

术后48小时内

测量方法：

Measure time point of outcome：

Within 48 hours after surgery

Measure method：

指标中文名：

肉眼血尿持续时间

指标类型：

主要指标

Outcome：

Duration of gross hematuria

Type：

Primary indicator

测量时间点：

从手术结束至肉眼血尿完全消失

测量方法：

Measure time point of outcome：

From the end of the surgery until the complete disappearance of gross hematuria

Measure method：

指标中文名：

术后早期尿控率

指标类型：

次要指标

Outcome：

Early postoperative urinary continence rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后冲洗液用量

指标类型：

次要指标

Outcome：

Amount of postoperative irrigation solution

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

拔除导尿管时间

指标类型：

次要指标

Outcome：

Time of catheter removal

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛评分

指标类型：

次要指标

Outcome：

Pain Score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

并发症

指标类型：

次要指标

Outcome：

Complications

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 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）：

采用区组随机化方法，区组长度在4和6之间随机变化，按1:1比例分配。随机分配序列由不参与临床研究的独立统计学人员，在研究开始前使用R语言或SPSS软件一次性生成，并对实施人员严格保密。

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

A block randomization method was employed, with block sizes randomly varying between 4 and 6, and subjects assigned in a 1:1 ratio. The randomization sequence was generated in a single run prior to the start of the study by an independent statistician not involved in the clinical trial, using R or SPSS software, and was kept strictly confidential from the study personnel.

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：

研究采用受试者单盲设计

Blinding：

The study employed a single-blind design

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

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）：

不共享

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

No share

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：

本研究采用纸质病例报告表（CRF）结合电子表格进行数据管理。 1. 数据采集：由经过培训的研究护士或医师根据受试者住院病历、护理记录单及随访结果，及时、准确、完整地填写预先设计的纸质版CRF。填写错误需修改时，保留原始记录清晰可读（划双横线），在旁边注明正确值，并由修改者签名及注明日期。 2. 数据录入与核查：由两名数据录入员独立将纸质CRF上的数据录入至加密的Excel电子表格中。录入完成后，由第三名研究人员（数据质控员）使用Excel对比功能对两份独立录入的数据进行一致性核查。如发现不一致，则查阅原始CRF及原始病历进行修正。 3. 数据溯源与保存：纸质CRF表与对应受试者的原始住院病历、检验报告单复印件共同归档，存放于上锁的专用研究文件柜中。电子数据库文件设置只读密码，仅主要研究者和数据质控员有权访问。所有研究文件保存至研究结束后5年。

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

This study employs paper-based case report forms (CRFs) in conjunction with electronic spreadsheets for data management. 1. Data Collection: Trained research nurses or physicians completed the pre-designed paper-based CRFs in a timely, accurate, and complete manner based on the subjects’ hospital records, nursing notes, and follow-up results. When corrections were necessary, the original entry was retained in a clear and legible manner (by striking it through with two parallel lines), the correct value was noted alongside, and the corrector signed and dated the entry. 2. Data Entry and Verification: Two data entry clerks independently entered the data from the paper CRFs into an encrypted Excel spreadsheet. Upon completion of data entry, a third researcher (data quality control officer) used Excel’s comparison function to verify the consistency of the two independently entered datasets. If any discrepancies were found, the original CRF and original medical records were consulted for correction. 3. Data Traceability and Retention: Paper CRFs are archived together with the corresponding subject’s original hospital medical records and copies of laboratory reports, and stored in a locked, dedicated research filing cabinet. The electronic database files are password-protected and set to read-only; only the principal investigator and the data quality control officer have access. All research documents are retained for 5 years following the conclusion of the study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-27 17:28:30