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A Randomized Controlled Trial to Assess the Effectiveness and Safety of Acupuncture for Overactive Bladder: A Study in Hong Kong Patient Population
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注册号:

Registration number:

ChiCTR-INR-16010048 

最近更新日期:

Date of Last Refreshed on:

2017-04-11 

注册时间:

Date of Registration:

2016-11-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

針刺治療膀胱過度活躍症的臨床試驗研究 

Public title:

A Randomized Controlled Trial to Assess the Effectiveness and Safety of Acupuncture for Overactive Bladder: A Study in Hong Kong Patient Population 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

針刺治療膀胱過度活躍症的臨床試驗研究 

Scientific title:

A Randomized Controlled Trial to Assess the Effectiveness and Safety of Acupuncture for Overactive Bladder: A Study in Hong Kong Patient Population 

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:

CUHK_CCRB00537 

申请注册联系人:

Chan Yu Tat 

研究负责人:

LIN Zhixiu 

Applicant:

Chan Yu Tat 

Study leader:

LIN Zhixiu 

申请注册联系人电话:

Applicant telephone:

+852 60297697 

研究负责人电话:

Study leader's telephone:

+852 39436347 

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:

augustuschan@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

linzx@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/418 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/418 

申请注册联系人通讯地址:

Room 101,1/F, Li Wai Chun Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong 

研究负责人通讯地址:

Room 101,1/F, Li Wai Chun Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong 

Applicant address:

Room 101,1/F, Li Wai Chun Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong 

Study leader's address:

Room 101,1/F, Li Wai Chun Building, Chung Chi College, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong 

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:

School of Chinese Medicine, CUHK 

Applicant's institution:

School of Chinese Medicine, CUHK 

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:

NTWC/CREC/15147 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

New Territories West Cluster Research Ethics Committee 

Name of the ethic committee:

New Territories West Cluster Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-02-19 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

The Chinese University of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong 

Primary sponsor's address:

The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

香港特別行政區

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

Tuen Mun Hospital

具体地址:

Tuen Mun Hospital

Institution
hospital:

Tuen Mun Hospital

Address:

Tuen Mun Hospital

经费或物资来源:

Health and Medical Research Fund 

Source(s) of funding:

Health and Medical Research Fund 

研究疾病:

膀胱過度活躍症 

Target disease:

Overactive Bladder 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

1) to evaluate the effectiveness of acupuncture treatment for patients with OAB on the reduction of the frequency of incontinence episodes as derived from 7-day voiding diary; 2) to evaluate whether acupuncture treatment could improve the subjective symptoms in patients with OAB. 

Objectives of Study:

1) to evaluate the effectiveness of acupuncture treatment for patients with OAB on the reduction of the frequency of incontinence episodes as derived from 7-day voiding diary; 2) to evaluate whether acupuncture treatment could improve the subjective symptoms in patients with OAB. 

药物成份或治疗方案详述:

Traditional acupuncture treatment will be applied on the following acupoints: BL32 (Ciliao) (bilateral), BL23 (Shenshu) (bilateral), SP6 (Sanyinjiao) (bilateral), KI3 (Taixi) (bilateral), BL39 (Weiyang) (bilateral), BL28 (Pangguangshu) (bilateral), and CV4 (Guanyuan). A total 16 sessions of acupuncture treatment (twice per week) will be administered to patients in intervention group, two acupuncture treatment sessions per week in 8 weeks. Sham Acupuncture is a type of acupuncture in which needles of the same size as those of intervention group, however, the needles will not be penetrated into skin; instead, the needles are retracted into needle handle instead of penetrating skin at the same points as the treatment group. As such subjects will experience a non-penetrating pricking sensation instead of de-qi feeling, characterized as soreness, numbness, heaviness and pressurized feeling. Sham acupuncture without penetrating into skin. A total 16 sessions of sham acupuncture treatment (twice per week) will be administered to patients in sham acupuncture group in 8 weeks. 

Description for medicine or protocol of treatment in detail:

Traditional acupuncture treatment will be applied on the following acupoints: BL32 (Ciliao) (bilateral), BL23 (Shenshu) (bilateral), SP6 (Sanyinjiao) (bilateral), KI3 (Taixi) (bilateral), BL39 (Weiyang) (bilateral), BL28 (Pangguangshu) (bilateral), and CV4 (Guanyuan). A total 16 sessions of acupuncture treatment (twice per week) will be administered to patients in intervention group, two acupuncture treatment sessions per week in 8 weeks. Sham Acupuncture is a type of acupuncture in which needles of the same size as those of intervention group, however, the needles will not be penetrated into skin; instead, the needles are retracted into needle handle instead of penetrating skin at the same points as the treatment group. As such subjects will experience a non-penetrating pricking sensation instead of de-qi feeling, characterized as soreness, numbness, heaviness and pressurized feeling. Sham acupuncture without penetrating into skin. A total 16 sessions of sham acupuncture treatment (twice per week) will be administered to patients in sham acupuncture group in 8 weeks. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

Both male and female elderly at the age between 60 to 90 years old; Diagnosed as OAB wet-type (3 or more episodes of incontinence in the past 4 weeks that are no stress-incontinence) according to the diagnosis criteria of the ICS;Physically and mentally able to complete the 7-day voiding diary, Urinary Distress Inventory (UDI-6) and Incontinence Impact questionnaire (IIQ7) Able to give written inform consent (by patients themselves or by caretaker). 

Inclusion criteria

Both male and female elderly at the age between 60 to 90 years old; Diagnosed as OAB wet-type (3 or more episodes of incontinence in the past 4 weeks that are no stress-incontinence) according to the diagnosis criteria of the ICS;Physically and mentally able to complete the 7-day voiding diary, Urinary Distress Inventory (UDI-6) and Incontinence Impact questionnaire (IIQ7) Able to give written inform consent (by patients themselves or by caretaker). 

排除标准:

OAB symptom caused by stroke or spinal injury; Life threatening infection; Unconsciousness or severe cognition deficits; Dementia caused by Alzheimer’s disease or other neurodegenerative diseases; Undergone incontinence surgery previously; On short-term active diuretic treatment or taking diuretic medication; Had previously received acupuncture treatment for any medical conditions; Patients who are on drug treatment for OAB; Patients who diagnosed as stress urinary incontinence; Pregnancy; Suffering the following diseases: untreated urinary tract infection, urogenital tumors, prostate tumor, benign prostatic hyperplasia, chronic urinary retention. 

Exclusion criteria:

OAB symptom caused by stroke or spinal injury; Life threatening infection; Unconsciousness or severe cognition deficits; Dementia caused by Alzheimers disease or other neurodegenerative diseases; Undergone incontinence surgery previously; On short-term active diuretic treatment or taking diuretic medication; Had previously received acupuncture treatment for any medical conditions; Patients who are on drug treatment for OAB; Patients who diagnosed as stress urinary incontinence; Pregnancy; Suffering the following diseases: untreated urinary tract infection, urogenital tumors, prostate tumor, benign prostatic hyperplasia, chronic urinary retention. 

研究实施时间:

Study execute time:

From2017-03-01To 2018-08-31 

干预措施:

Interventions:

组别:

Two groups

样本量:

100

Group:

Two groups

Sample size:

干预措施:

Acupuncture 30-minute for 8 weeks versus Sham acupuncture without penetrating into skin for 8 weeks

干预措施代码:

Intervention:

Acupuncture 30-minute for 8 weeks versus Sham acupuncture without penetrating into skin for 8 weeks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

The Chinese University of Hong Kong 

单位级别:

The Chinese University of Hong Kong 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

The Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

7-day voiding diary

指标类型:

主要指标 

Outcome:

7-day voiding diary

Type:

Primary indicator 

测量时间点:

baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)

测量方法:

records daily micturitions and symptoms, such as the time of micturition, voided volume per micturition and incontinence episodes in the most recent seven days

Measure time point of outcome:

baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)

Measure method:

records daily micturitions and symptoms, such as the time of micturition, voided volume per micturition and incontinence episodes in the most recent seven days

指标中文名:

Urine NGF level

指标类型:

次要指标 

Outcome:

Urine NGF level

Type:

Secondary indicator 

测量时间点:

baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)

测量方法:

Urine NGF level will be detected from the urine of subjects by ELISA kits

Measure time point of outcome:

baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)

Measure method:

Urine NGF level will be detected from the urine of subjects by ELISA kits

采集人体标本:

Collecting sample(s)
from participants:

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 60 years
最大 Max age 90 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):

using a computer program (Random Allocation Software, version 1.0; Msaghaei) to generate random numbers. The list of randomization number will be kept by a research staff member who will be responsible for assigning the corresponding intervention code based on the list to the recruited patients.

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

using a computer program (Random Allocation Software, version 1.0; Msaghaei) to generate random numbers. The list of randomization number will be kept by a research staff member who will be responsible for assigning the corresponding intervention code based on the list to the recruited patients.

盲法:

Double blind

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-11-29
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