Acupuncture in the treatment of early postpartum stress urinary incontinence: A pilot randomised controlled trial

注册号:

Registration number:

ITMCTR2024000290

最近更新日期:

Date of Last Refreshed on:

2024-08-24

注册时间:

Date of Registration:

2024-08-24

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺治疗早期产后压力性尿失禁的随机对照预试验

Public title:

Acupuncture in the treatment of early postpartum stress urinary incontinence: A pilot randomised controlled trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺治疗早期产后压力性尿失禁的随机对照预试验

Scientific title:

Acupuncture in the treatment of early postpartum stress urinary incontinence: A pilot randomised controlled trial

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:

徐萌

研究负责人:

史术峰

Applicant:

Xu Meng

Study leader:

Shi Shufeng

申请注册联系人电话:

Applicant telephone:

18810383185

研究负责人电话:

Study leader's telephone:

18810383185

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:

chilli.xu@163.com

研究负责人电子邮件:

Study leader's E-mail:

17860506395@163.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:

北京市朝阳区安定门外小关街51号

研究负责人通讯地址:

北京市朝阳区安定门外小关街51号

Applicant address:

No.51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China

Study leader's address:

No.51 Xiaoguan Street, Andingmenwai, Chaoyang 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:

北京中医药大学第三附属医院

Applicant's institution:

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

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:

BZYSY-2024KYKTPJ-23

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

北京中医药大学第三附属医院科研伦理委员会

Name of the ethic committee:

IRB of The third Hospital affiliated to Beijing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/23 0:00:00

伦理委员会联系人:

赵莹

Contact Name of the ethic committee:

Zhao Ying

伦理委员会联系地址:

北京市朝阳区安定门外小关街51号

Contact Address of the ethic committee:

No.51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-84985602

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zydsyec2023@126.com

研究实施负责(组长)单位:

北京中医药大学第三附属医院

Primary sponsor:

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

研究实施负责(组长)单位地址:

北京中医药大学第三附属医院

Primary sponsor's address:

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

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):

北京中医药大学第三附属医院

具体地址:

北京市朝阳区安定门外小关街51号

Institution
hospital:

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

Address:

No.51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China

经费或物资来源:

科室自筹

Source(s) of funding:

Section self-financed

研究疾病:

产后压力性尿失禁

研究疾病代码:

Target disease:

Postpartum stress urinary incontinence

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:

产后压力性尿失禁是女性最常见的盆底功能性障碍疾病之一。在中国,针刺治疗女性压力性尿失禁的应用十分广泛,但是目前尚缺乏针刺治疗产后压力性尿失禁的高质量循证医学证据。本预试验的目的在于初步评估针刺治疗产后压力性尿失禁的有效性和安全性,为正式试验的样本量估算和研究方案可行性提供参考依据。

Objectives of Study:

Postpartum stress urinary incontinence is one of the most common pelvic floor dysfunction disorders in women. In China, acupuncture is widely used to treat female stress urinary incontinence, but there is a lack of high-quality evidence-based medical evidence on acupuncture for postpartum stress urinary incontinence. The purpose of this pre-trial is to initially assess the effectiveness and safety of acupuncture for postpartum stress urinary incontinence, and to provide a reference basis for sample size estimation and feasibility of the study protocol for the formal trial.

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)年龄20-40岁; (2)产后42天-1年内; (3)咳嗽、打喷嚏、大笑或体力活动时漏尿,压力结束时停止,三个月内发作≥1次; (4)1小时尿垫试验中尿垫重量增加大于1g小于50g; (5)符合Ingelman-Sundberg分度法的轻度和中度SUI; (6)自愿参加研究并签署知情同意书。 以上任意一项为“否”不能参加试验。

Inclusion criteria

(1) Age 20-40 years; (2) Within 42 days-1 year postpartum; (3) Leakage of urine during coughing, sneezing, laughing or physical activity that stops at the end of stress, with ≥1 episode in three months; (4) Increase in pad weight greater than 1g less than 50g in a 1-hour pad test; (5) Mild and moderate SUI consistent with the Ingelman-Sundberg scale; (6) Voluntary participation in the study and signing the informed consent form. If any of the above items is "No", the participant cannot participate in the trial.

排除标准:

(1)多胎妊娠; (2)孕前有尿失禁症状; (3)有尿频、尿急症状; (4)有尿路感染症状; (5)产后恶露未净,或产后出现宫腔残留者; (6)伴有子宫或其他妇科疾病; (7)曾有重度合并症,如合并巨大儿、第二产程延长、前置胎盘、先兆早产或妊娠高血压; (8)曾有剖宫产指征或阴道分娩禁忌症; (9)曾接受过尿失禁手术或盆底手术; (10)盆腔器官脱垂大于2度; (11)患有膀胱过度活动症或泌尿系统肿瘤; (12)逼尿肌收缩力减弱; (13)近一个月内接受持续或规律性的SUI的特定治疗,或服用可能影响膀胱功能的药物; (14)严重的心血管、脑、肝、肾或精神疾病,糖尿病,多系统萎缩,马尾损伤或脊髓损伤; (15)有心脏起搏器、金属过敏或严重的针头恐惧症; (16)近3个月内参加过其他临床研究。

Exclusion criteria:

(1) Multiple pregnancies; (2) Symptoms of urinary incontinence before pregnancy; (3) Having symptoms of urinary frequency and urgency; (4) Having symptoms of urinary tract infection; (5) With unclean postnatal discharge, or with uterine residue after delivery; (6) With uterine or other gynaecological diseases; (7) Having had severe comorbidities, such as combined macrosomia, prolonged second stage of labour, placenta praevia, preterm labour or gestational hypertension; (8) Previous indication for caesarean section or contraindication to vaginal delivery; (9) Previous incontinence surgery or pelvic floor surgery; (10) Have pelvic organ prolapse greater than 2nd degree; (11) Has overactive bladder or urinary tumour; (12) Have diminished contractility of the forced urinary muscles; (13) Receiving specific treatment for continuous or regular SUI within the last month, or taking medications that may affect bladder function; (14) Severe cardiovascular, cerebral, hepatic, renal, or psychiatric disease, diabetes mellitus, multiple system atrophy, cauda equina injury, or spinal cord injury; (15) Have a pacemaker, metal allergy or severe needle phobia; (16) Participation in another clinical study within the last 3 months.

研究实施时间:

Study execute time:

From 2024-09-01

To      2025-07-22

征募观察对象时间:

Recruiting time:

From 2024-09-01

To      2025-07-22

干预措施:

Interventions:

组别:

对照组

样本量:

36

Group:

Control group

Sample size:

干预措施:

盆底肌训练+假针刺

干预措施代码:

Intervention:

pelvic floor muscle training + sham acupuncture

Intervention code:

组别:

治疗组

样本量:

36

Group:

Treatment group

Sample size:

干预措施:

盆底肌训练+针刺

干预措施代码:

Intervention:

pelvic floor muscle training + acupuncture

Intervention code:

样本总量 Total sample size : 72

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):

北京中医药大学第三附属医院

单位级别:

三级甲等

Institution/hospital:

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

Level of the institution:

grade A class three hospital

测量指标:

Outcomes:

指标中文名:

盆底肌力评估

指标类型:

次要指标

Outcome:

Pelvic floor muscle strength assessment

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICIQ-SF简表评分

指标类型:

次要指标

Outcome:

International Consultation on Incontinence Questionnaire - Short Form

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一小时尿垫试验

指标类型:

主要指标

Outcome:

One hour urine pad test

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿失禁生活质量量表I-QOL

指标类型:

次要指标

Outcome:

Incontinence Quality of Life Questionnaire

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

72小时膀胱日记

指标类型:

次要指标

Outcome:

72-hour bladder diary

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:

组织:

Sample Name:

not have

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 20
Min age years
最大 40
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):

合格的受试者将采用随机数字表法,将72例早期产后压力性尿失禁患者按照1:1的比例随机为治疗组和对照组2组,每组各36例,一位不参与本课题研究的随机号管理员负责随机号码分配。参与者、结果评估者和统计分析人员对治疗分配不知情。对于符合纳入标准的患者,由招募人员打电话询问随机号管理员患者的随机号和分组情况并记录在患者的CRF表上,同时随机号管理员备份记录患者的随机号和分组情况。

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

Eligible subjects will be randomised into 2 groups of 36 patients each, treatment and control, in a 1:1 ratio of 72 patients with early postpartum stress urinary incontinence, using a random number table method, with a random number administrator, who is not involved in this study, being responsible for the random number allocation. Participants, outcome assessors, and statistical analysts were unaware of treatment allocation. For patients who met the inclusion criteria, the random number administrator was called by the recruiter to ask the random number administrator about the patient's random number and grouping and recorded it on the patient's CRF form, while the random number administrator backed up to record the patient's random number and grouping.

盲法:

本试验对于受试者、疗效评价者以及统计分析人员设盲。对于上述人员,仅以A、B代表组别。统计分析人员在统计分析时组别仅以A、B代表组别,统计结束后揭盲。由于针刺本身的特点,本试验未对针灸医师设盲。针灸医师、疗效评价者和统计人员分别由不同的人员承担,做到三者分离。 为了帮助最大限度地使受试者设盲,对照组将使用安慰针,在试验中两组都将使用粘合垫,尽可能最大程度控制试验偏倚。 为了评价盲法是否成功,要求所有受试者在首次治疗后和最后一次治疗结束后5分钟内猜测其接受的治疗为针刺还是假针刺。

Blinding:

The trial was blinded for subjects efficacy evaluators and statistical analysts. For the above persons groups are represented by A and B only. The statistical analysts were blinded to the groups represented by A and B only during the statistical analyses and the blinding was done after the statistical analyses were completed. Due to the characteristics of acupuncture itself this trial was not blinded to acupuncturists. Acupuncturists efficacy evaluators and statisticians were undertaken by separate personnel to achieve separation of the three. To help maximise blinding of subjects placebo needles will be used in the control group and adhesive pads will be used in both groups in the trial to control trial bias as maximally as possible. To evaluate the success of the blinding all subjects will be asked to guess whether the treatment they received was a pinprick or a sham within 5 minutes after the first treatment and 5 minutes after the last treatment.

是否共享原始数据:

IPD sharing:

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):

https://pubmed.ncbi.nlm.nih.gov/

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

https://pubmed.ncbi.nlm.nih.gov/

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:

采用CRF表进行数据管理

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

Data management using CRF tables

数据管理委员会:

Data Managemen Committee:

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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