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基于耳迷走神经刺激理论观察揿针对膀胱过度活动伴焦虑症状的效果研究

注册号：

Registration number：

ITMCTR2025001478

最近更新日期：

Date of Last Refreshed on：

2025-07-26

注册时间：

Date of Registration：

2025-07-26

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于耳迷走神经刺激理论观察揿针对膀胱过度活动伴焦虑症状的效果研究

Public title：

Study on the effect of Press needle on overactive bladder with anxiety symptoms based on the theory of ear vagus nerve stimulation

注册题目简写：

揿针治疗膀胱过度活动症伴焦虑症状患者

English Acronym：

Press needle treatment for patients with overactive bladder and anxiety symptoms

研究课题的正式科学名称：

基于耳迷走神经刺激理论观察揿针对膀胱过度活动伴焦虑症状的效果研究

Scientific title：

Study on the effect of Press needle on overactive bladder with anxiety symptoms based on the theory of ear vagus nerve stimulation

研究课题的正式科学名称简写：

Scientific title acronym：

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：

严媛媛

研究负责人：

周萍

Applicant：

Yan yuan yuan

Study leader：

Zhou ping

申请注册联系人电话：

Applicant telephone：

15755010267

研究负责人电话：

Study leader's telephone：

13776630616

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：

2796048537@qq.com

研究负责人电子邮件：

Study leader's E-mail：

834511175@qq.com

申请单位网址(自愿提供)：

Study leader's 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：

江苏省南京市秦淮区华侨路街道汉中路282号南京中医药大学

研究负责人通讯地址：

江苏省南京市秦淮区汉中路155号

Applicant address：

Nanjing University of Traditional Chinese Medicine No. 282 Hanzhong Road Huaqiao Road Street Qinhuai District Nanjing Jiangsu Province

Study leader's address：

No. 155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

申请注册联系人邮政编码：

Applicant postcode：

210029

研究负责人邮政编码：

Study leader's postcode：

210029

申请人所在单位：

南京中医药大学

Applicant's institution：

Nanjing University of Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2025NL-008-02

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

南京中医药大学附属医院（江苏省中医院）伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine).

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/14 0:00:00

伦理委员会联系人：

王卯

Contact Name of the ethic committee：

wang mao

伦理委员会联系地址：

江苏省南京市秦淮区汉中路155号

Contact Address of the ethic committee：

No. 155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

025-86560515

伦理委员会联系人邮箱：

Contact email of the ethic committee：

llwyhbgs@qq.com

研究实施负责（组长）单位：

江苏省中医院

Primary sponsor：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

江苏省南京市秦淮区汉中路155号

Primary sponsor's address：

No. 155 Hanzhong Road Qinhuai District Nanjing 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)：

南京

Country：

China

Province：

jingsu

City：

Nanjing

单位(医院)：

江苏省中医院

具体地址：

江苏省南京市秦淮区汉中路155号

Institution
hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Address：

No. 155 Hanzhong Road Qinhuai District Nanjing City Jiangsu Province

经费或物资来源：

江苏省中医院

Source(s) of funding：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

研究疾病：

膀胱过度活动症 和焦虑

研究疾病代码：

Target disease：

Overactive bladder and anxiety

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

1、通过揿针刺激耳迷走神经干预膀胱过度活动症患者伴焦虑症状中临床疗效，改善患者焦虑情绪后可以更好的改善患者症状。 2、基于5-羟色胺、中性粒细胞与淋巴细胞比值指标验证揿针干预膀胱过度活动症伴焦虑症状患者效果； 3、验证揿针持续性治疗的有效性，减少患者的夜尿情况。 4、为后期OAB的临床治疗提供新的治疗方式。

Objectives of Study：

To evaluate the clinical efficacy of press needle stimulation of the auricular branch of the vagus nerve in patients with overactive bladder (OAB) accompanied by anxiety symptoms and to determine whether improvement in anxiety can lead to better symptom relief. To assess the therapeutic effects of press needle intervention in OAB patients with anxiety based on biomarkers such as serotonin (5-HT) levels and the neutrophil-to-lymphocyte ratio (NLR). To verify the effectiveness of sustained press needle treatment in reducing nocturia symptoms in patients. To provide a novel therapeutic approach for future clinical management of OAB.

药物成份或治疗方案详述：

两组患者均予米拉贝隆缓释片(贝坦利，生产企业：Avara Pharmaceutical Technologies Inc，50mg/片)，50mg/天，共治疗2周。同时对患者进行健康宣教。 （对照组 行为疗法括盆底肌训练、生活习惯改变以及排尿训练。 1）盆底肌训练：即指导患者做提肛运动。 方法[14]：腹部放松，收紧肛门及阴道5～10秒，放松5～10秒，重复上述动作，每天至少100个，共6周（根据患者的具体情况进行指导）。 2）生活习惯改变： ①建议患者适量摄入液体（减少咖啡、茶叶、奶茶的摄入），液体量摄入少会提高尿液浓度,易刺激膀胱黏膜,从而加重尿急、尿频等症状和增加泌尿系感染机会;液体摄入过多则会加重膀胱过度活动症症状和尿失禁，建议患者每天摄入液体量约1500mL（具体按照患者情况加减量）。 ②引导患者保持良好的健康生活方式，每天坚持盆底功能锻炼,增强身体素质，保持正常的体重,避免超重增加膀胱的压力。 3）排尿训练： ③排尿日记：记录3天排尿日记，根据患者排尿日记（包括每天总的排尿次数、排尿间隔时间、单次排尿量、尿急程度、白天排尿次数、夜间排尿次数以及漏尿情况），根据3天排尿日记制定个性化的膀胱管理方案例如饮水计划、排尿计划。 ④训练患者有意识地延长排尿时间和定时排尿,并逐渐延长排尿的间隔时间,使单次尿量达到250-300mL以上,以增大膀胱容量和减少逼尿肌不稳定。 ⑤强调患者尿急时全身放松,做呼吸动作来放松膀胱。分散、转移患者注意力,如听音乐、读书、看报、看视频等。 ⑥夜尿多的患者,告知患者睡前排空小便,少饮水,以减少夜尿,提高患者自行控制排尿的能力。） 试验组：（对照组基础上+揿针组。） 1）材料：揿针（品牌：清铃牌；针长x直径：0.20x0.6mm；生产厂家：日本制造；标准号：国械注进20162201259） 2）操作方法：采用耳穴探测仪（品牌：小松，型号：XS-100A）进行探穴以寻找穴位敏感点，先常规75%酒精消毒，在将揿针（0.20×0.6mm）填埋在耳部心、肝、肾、膀胱（心：耳甲腔正中凹陷处，即耳甲15区,CO15；肝：耳甲艇的后下部，即耳甲12区，CO12；肾：对耳轮下脚下方后部，即耳甲10区,CO10；膀胱：对耳轮下脚下方中部，即耳甲9区,CO9；），由轻到重、再由重到轻按压，以局部酸痛、胀热、患者耐受为宜，每穴每次按压约1min，每日按压3-4次，留针3-4天后取下进行下一次治疗，双耳交替进行。疗程：每周两次，每次间隔3-4天，共6周。居家期间每天自行进行按压操作，每3-4天就诊中医护理门诊时，由门诊中医治疗护士评估家属动作掌握情况并纠正。 3）揿针治疗均由本院专职中医治疗师进行操作。

Description for medicine or protocol of treatment in detail：

Both groups of patients were given Mirabon sustained-release tablets (Betal produced by Avara Pharmaceutical Technologies Inc. 50mg per tablet) at a dose of 50mg per day for a total of 2 weeks. Health education was also provided to the patients. control group behavioral therapy included pelvic floor muscle training lifestyle changes and urination training. 1) Pelvic floor muscle training: Patients were instructed to perform Kegel exercises. Method [14]: Relax the abdomen tighten the anus and vagina for 5-10 seconds then relax for 5-10 seconds repeat this action aiming for at least 100 repetitions daily for a total of 6 weeks (adjustments based on individual patient conditions). 2) Lifestyle changes: ① Patients were advised to moderately reduce their intake of liquids (such as coffee tea and milk tea). A low fluid intake can increase urine concentration which can irritate the bladder lining and worsen symptoms like urgency and frequency as well as increase the risk of urinary tract infections; an excessive fluid intake can exacerbate symptoms of overactive bladder and incontinence. It is recommended that patients consume about 1500mL of liquid daily (adjustments based on individual patient conditions). ② Patients were encouraged to maintain a healthy lifestyle including daily pelvic floor function exercises to improve physical fitness maintain a normal weight and avoid overweight which can increase pressure on the bladder. 3) Urination Training: ③ Urination Diary: Keep a three-day urination diary. Based on the patient's diary including the total number of urinations per day the intervals between urinations the volume of each urination the urgency level the number of daytime and nighttime urinations and any incontinence develop a personalized bladder management plan such as a water intake plan and a urination schedule. ④ Train patients to consciously extend their urination time and urinate at fixed times gradually increasing the intervals between urinations to achieve a single urine volume of 250-300mL or more to increase bladder capacity and reduce detrusor instability. ⑤ Emphasize that when patients feel urgent they should relax their entire body and perform breathing exercises to relax the bladder. Distract and divert the patient's attention such as by listening to music reading books newspapers or watching videos. ⑥ For patients who frequently urinate at night advise them to empty their bladder before bedtime and drink less water to reduce nocturia and improve their ability to control urination.) Experimental group: (Control group + needle group..) 1) Materials: Acupuncture needles (Brand: Qingling; Length and diameter: 0.20x0.6mm; Manufacturer: Japan; Standard number: Guo Jian Zhu Jin 20162201259) 2) Procedure: Use an auricular acupoint detector (Brand: Komatsu Model: XS-100A) to locate sensitive points on the ear. Disinfect the area with 75% alcohol first. Place the acupuncture needle (0.20×0.6mm) in the heart liver kidney and bladder points of the ear (Heart: the center depression of the auricle i.e. Auricle 15 CO15; Liver: the lower rear part of the auricle i.e. Auricle 12 CO12; Kidney: the lower rear part below the lower foot of the antihelix i.e. Auricle 10 CO10; Bladder: the middle part below the lower foot of the lower earlobe i.e. Auricle 9 CO9). Press from light to heavy and then from heavy to light until local soreness distension or heat is felt which the patient can tolerate. Each point should be pressed for about 1 minute 3-4 times daily. The needle should remain in place for 3-4 days before removal for the next treatment alternating between both ears. Treatment schedule: Twice a week with a 3-4 day interval between sessions for a total of 6 weeks. During the home treatment period perform the pressing operation daily. Every 3-4 days visit the TCM nursing clinic for assessment and correction by the TCM nurse. 3) All acupuncture treatments are performed by the hospital's full-time TCM therapists.

纳入标准：

1)门诊或住院病例，年龄18-65岁，病程超过2个月女性患者； 2）符合《中国泌尿外科疾病诊断治疗指南》(2025版)膀胱过度活动症诊断标准； 3）中医诊断辩证分型为肾虚湿热型 4）会使用排尿日记者； 5）膀胱过度活动症问卷（OABSS）评分3-11分（包括3分和11分、OABSS评分≤2分为无症状，仅纳入轻中度OAB患者），7分≤HAMA评分≤29分（仅纳入轻中度焦虑症状患者）。 6）知情同意，志愿受试。获得知情同意书过程应符合GCP规定。

Inclusion criteria

Outpatients or inpatients female patients aged 18–65 years with a disease duration of more than 2 months; Meeting the diagnostic criteria for overactive bladder (OAB) as defined in the Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases (2025 edition); Classified as the Kidney Deficiency with Damp-Heat syndrome according to traditional Chinese medicine (TCM) differentiation; Capable of using a voiding diary; OAB Symptom Score (OABSS) between 3 and 11 (inclusive); OABSS ≤ 2 is considered asymptomatic thus only patients with mild to moderate OAB are included. Hamilton Anxiety Scale (HAMA) scores between 7 and 29 (inclusive) indicating mild to moderate anxiety symptoms; Providing informed consent voluntarily. The informed consent process must comply with Good Clinical Practice (GCP) guidelines.

排除标准：

1）急性感染和尿路感染的患者； 2）膀胱疼痛综合征、间质性膀胱炎；妊娠、哺乳期和妊娠计划的患者；严重高血压及高血压控制不稳定患者；严重心、脑、肝、肾及血液疾病； 3）存在揿针禁忌症者；有晕针史，对揿针治疗存在恐惧或抗拒者 4）排除OABSS≥12分（重度OAB）或OABSS≤2分（无OAB）或HAMA≥30分（重度焦虑）或HAMA≤6分（无焦虑） 5）皮肤过敏者、其他皮肤疾病的患者； 6）焦虑症、抑郁症确诊患者。

Exclusion criteria：

1) Patients with acute infections or urinary tract infections; 2) Patients with bladder pain syndrome interstitial cystitis; pregnant breastfeeding or planning to become pregnant; patients with severe hypertension or unstable blood pressure control; patients with severe heart brain liver kidney or blood diseases; 3) Patients with contraindications to acupuncture; those with a history of needle phobia and fear or resistance to acupuncture treatment; 4) Exclude patients with OABSS (Overactive Bladder Symptom Scale) ≥12 (severe OAB) or OABSS ≤2 (no OAB) or HAMA (Hospital Anxiety and Munchausen's Hypochondriac Checklist) ≥30 (severe anxiety) or HAMA ≤6 (no anxiety); 5) Patients with skin allergies or other skin conditions; 6) Patients diagnosed with anxiety disorder or depression.

研究实施时间：

Study execute time：

从From 2025-02-14

至To      2026-02-14

征募观察对象时间：

Recruiting time：

从From 2025-02-14

至To      2026-02-14

干预措施：

Interventions：

组别：

对照组（行为疗法）

样本量：

85

Group：

Control group (behavioral therapy)

Sample size：

干预措施：

药物治疗+行为疗法（盆底肌训练、生活习惯改变以及排尿训练）

干预措施代码：

Intervention：

Medication + behavioral therapy (pelvic floor muscle training lifestyle changes and urination training)

Intervention code：

组别：

试验组（揿针组）

样本量：

85

Group：

Experimental group (needle pressing group)

Sample size：

干预措施：

对照组基础上+先常规75%酒精消毒，在将揿针填埋在耳部心CO15、肝CO12、肾CO10、膀胱CO9，每个穴位1min，每日按压3-4次，间隔3-4天，双耳交替进行，每周两次，共6周。

干预措施代码：

Intervention：

On the basis of the control group+First 75% alcohol was used for routine disinfection. The lancet was buried in the ear and heart CO15 liver CO12 kidney CO10 and bladder CO9. Each acupoint was pressed for 1min and the lancet was pressed 3-4 times a day with an interval of 3-4 days. The two ears were alternated twice a week for a total of 6 weeks.

Intervention code：

样本总量 Total sample size ： 170

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)：

南京

Country：

China

Province：

jingsu

City：

Nanjing

单位(医院)：

江苏省中医院

单位级别：

三级甲等医院

Institution/hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary Grade A Hospital

测量指标：

Outcomes：

指标中文名：

中医症候积分及疗效评价

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine symptom score and efficacy evaluation

Type：

Secondary indicator

测量时间点：

治疗前、治疗第2周、治疗第4周、治疗第6周

测量方法：

中医症候积分量表

Measure time point of outcome：

Before treatment 2nd week of treatment 4th week of treatment 6th week of treatment

Measure method：

Traditional Chinese Medicine symptom scoring scale

指标中文名：

血液中5-羟色胺水平

指标类型：

主要指标

Outcome：

Serotonin levels in the blood

Type：

Primary indicator

测量时间点：

治疗前、治疗6周后

测量方法：

酶联免疫吸附法

Measure time point of outcome：

Before treatment and after 6 weeks of treatment

Measure method：

Enzyme-linked immunosorbent assay（ELISA）

指标中文名：

白天次数、尿急次数和夜尿次数

指标类型：

主要指标

Outcome：

Daytime frequency urgency frequency and nocturia frequency

Type：

Primary indicator

测量时间点：

治疗前、治疗第2周、治疗第4周、治疗第6周

测量方法：

排尿日记

Measure time point of outcome：

Before treatment 2nd week of treatment 4th week of treatment 6th week of treatment

Measure method：

Urination diary

指标中文名：

最大尿流率和残余尿量和膀胱最大容量

指标类型：

次要指标

Outcome：

Maximum urine flow rate and residual urine volume and maximum bladder capacity

Type：

Secondary indicator

测量时间点：

治疗前、治疗6周后

测量方法：

尿流率记和便携式膀胱扫描仪

Measure time point of outcome：

Before treatment and after 6 weeks of treatment

Measure method：

Uroflowmeter and portable bladder scanner

指标中文名：

汉密尔抑郁量表和匹兹堡睡眠质量指数量表

指标类型：

次要指标

Outcome：

Hamilton Depression Rating Scale and Pittsburgh Sleep Quality Index

Type：

Secondary indicator

测量时间点：

治疗前、治疗第2周、治疗第4周、治疗第6周

测量方法：

汉密尔抑郁量表和匹兹堡睡眠质量指数量表

Measure time point of outcome：

Before treatment 2nd week of treatment 4th week of treatment 6th week of treatment

Measure method：

Hamilton Depression Rating Scale and Pittsburgh Sleep Quality Index

指标中文名：

焦虑缓解应答率

指标类型：

主要指标

Outcome：

Anxiety relief response rate

Type：

Primary indicator

测量时间点：

治疗前、治疗第2周、治疗第4周、治疗第6周

测量方法：

汉密尔顿焦虑量表

Measure time point of outcome：

Before treatment, 2nd week of treatment, 4th week of treatment, 6th week of treatment

Measure method：

Hamilton Anxiety Rating Scale

指标中文名：

膀胱过度活动症症状评分表

指标类型：

主要指标

Outcome：

Overactive Bladder Symptom Score

Type：

Primary indicator

测量时间点：

治疗前、治疗第2周、治疗第4周、治疗第6周

测量方法：

膀胱过度活动症症状评分表

Measure time point of outcome：

Before treatment 2nd week of treatment 4th week of treatment 6th week of treatment

Measure method：

Overactive Bladder Symptom Score

指标中文名：

国际尿失禁咨询问卷-膀胱过度活动症调查问卷

指标类型：

次要指标

Outcome：

International Incontinence Consultation Questionnaire-Overactive Bladder Questionnaire

Type：

Secondary indicator

测量时间点：

治疗前、治疗第2周、治疗第4周、治疗第6周

测量方法：

国际尿失禁咨询问卷-膀胱过度活动症调查问卷

Measure time point of outcome：

Before treatment 2nd week of treatment 4th week of treatment 6th week of treatment

Measure method：

International Incontinence Consultation Questionnaire-Overactive Bladder Questionnaire

指标中文名：

血清中性粒细胞与淋巴细胞比值(NLR)

指标类型：

次要指标

Outcome：

Serum neutrophil-to-lymphocyte ratio (NLR)

Type：

Secondary indicator

测量时间点：

治疗前、治疗6周后

测量方法：

血液测量

Measure time point of outcome：

Before treatment and after 6 weeks of treatment

Measure method：

Blood measurement

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

由专门的人员（不参与任何的研究过程）运用SPSS26.0统计软件产生包括编号、组别的随机数，将产生的编号与组别分别填入随机分配卡中，再将随机分配卡用不透光纸密封。受试者按照就诊的先后顺序拿到信封，根据信封中所提示的组别与编号分别进入对照组、试验组。

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

Special personnel (who do not participate in the research process) use SPSS26.0 statistical software to generate random numbers including a sequence number and group assignment. These numbers and group assignments are then recorded on random assignment cards which are sealed with opaque paper. Participants receive their envelopes in the order of their visit and they enter the control or experimental group based on the group and number indicated in the envelope.

盲法：

本试验中，将对结果评估员和统计分析师实施盲法，小组的分配仅表示为A或B。统计分析师将不知道实际分组的情况下进行分析没并且只有在统计分析后才会揭盲。由于揿针属于针灸的一种，由于其特殊性，盲法不适用于中医专职治疗师以及患者（因为揿针存在痛感，是否真正操作患者可以知晓）。中医专职治疗师、结果评估员和统计学家的角色将由不同的个体执行，以确保独立性并最大限度地减少偏见。为了帮助维持参与者盲法，两组都将以尽可能控制潜在的偏差。

Blinding：

In this trial the results evaluators and statistical analysts will be blinded with group assignments denoted only as A or B. The statistical analysts will conduct their analysis without knowing the actual group assignments and will only unblind after the statistical analysis is completed. Given that pricking needles are a form of acupuncture the blinding method is not suitable for traditional Chinese medicine (TCM) specialists and patients due to the pain associated with pricking needles which could reveal whether the treatment was performed on a patient. To ensure independence and minimize bias different individuals will perform the roles of TCM specialists result evaluators and statisticians. Both groups will strive to control potential biases to help maintain participant blindness.

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）：

2026年6月 Excel表格

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

September 2026 Excel table

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：

ResMan，为一种基于互联网的EDC

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

ResMan （An Internet-based EDC）

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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