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陰道子宮托治療盆腔器官脫垂與應力性尿失禁的隨機對照試驗
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注册号：

Registration number：

 ChiCTR2000034613 

最近更新日期：

Date of Last Refreshed on：

 2020-07-12 12:15:49 

注册时间：

Date of Registration：

 2020-07-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

陰道子宮托治療盆腔器官脫垂與應力性尿失禁的隨機對照試驗

Public title：

Vaginal pessary in the management of pelvic organ prolapse with stress urinary incontinence: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

陰道子宮托治療盆腔器官脫垂與應力性尿失禁的隨機對照試驗

Scientific title：

Vaginal pessary in the management of pelvic organ prolapse with stress urinary incontinence: a randomized controlled trial

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：

Cheung Yau Kar Rachel 

研究负责人：

Lee Yung Ting 

Applicant：

Cheung Yau Kar Rachel 

Study leader：

Lee Yung Ting 

申请注册联系人电话：

Applicant telephone：

 +852 55699569

研究负责人电话：

Study leader's
telephone：

+852 29901111

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：

 rachelcheung@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 lyt271@ha.org.hk

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：

中國香港特別行政區新界沙田威爾士親王醫院婦產科學系

研究负责人通讯地址：

中國香港特別行政區新界葵青區下葵湧荔景瑪嘉烈醫院路2-10

Applicant address：

1E, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Study leader's address：

2-10 Princess Margaret Hospital Road, Lai King, Ha Kwai Chung, Kwai Tsing, New Territories, Hong Kong SAR, 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：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

瑪嘉烈醫院婦產科

Affiliation of the Leader：

Department of Obstetrics and Gynaecology, Princess Margaret Hospital

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：

 2020.253

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-07-02 00:00:00

伦理委员会联系人：

Jenny Ng

Contact Name of the ethic committee：

Jenny Ng

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

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：

N/A

Primary sponsor：

Not applicable

研究实施负责（组长）单位地址：

N/A

Primary sponsor's address：

Not applicable

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Departmental Funding

Source(s) of funding：

Departmental Funding

研究疾病：

盆腔器官脫垂與應力性尿失禁  

Target disease：

pelvic organ prolapse with stress urinary incontinence

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The aim of this randomized controlled trial is to compare the efficacy of vaginal ring pessaries and continence pessaries in the management of patients with both pelvic organ prolapse and stress urinary incontinence, based on the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ), and subjective improvement of symptoms.  

Objectives of Study：

The aim of this randomized controlled trial is to compare the efficacy of vaginal ring pessaries and continence pessaries in the management of patients with both pelvic organ prolapse and stress urinary incontinence, based on the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ), and subjective improvement of symptoms.

药物成份或治疗方案详述：

Patients will be assigned to either vaginal ring pessary group (vaginal pessary)or ring pessary with knob group (continence pessary) with equal probability. 

Description for medicine or protocol of treatment in detail：

Patients will be assigned to either vaginal ring pessary group (vaginal pessary)or ring pessary with knob group (continence pessary) with equal probability. 

纳入标准：

Inclusion criteria

排除标准：

1. Patients who had history of continence operations;
2. Patients who have conditions contraindicated to use vaginal pessary, such as silicone allergy and presence of vaginal ulcers;
3. Patients unwilling to try pessary treatment;
4. Patients who are planning for pregnancy, or mental incapacity;
5. Patients who cannot understand written Chinese;
6. Patients refuse to participate in the study.

Exclusion criteria：

1. Patients who had history of continence operations;
2. Patients who have conditions contraindicated to use vaginal pessary, such as silicone allergy and presence of vaginal ulcers;
3. Patients unwilling to try pessary treatment;
4. Patients who are planning for pregnancy, or mental incapacity;
5. Patients who cannot understand written Chinese;
6. Patients refuse to participate in the study.

研究实施时间：

Study execute time：

从 From 2020-07-20 00:00:00至 To 2023-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-07-20 00:00:00 至 To 2023-06-30 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 100

Group：

Group 1

Sample size：

干预措施：

vaginal ring pessaries

干预措施代码：

Intervention：

vaginal ring pessaries

Intervention code：

组别：

Group 2

样本量：

 100

Group：

Group 2

Sample size：

干预措施：

ring pessary with knob group (continence pessary)

干预措施代码：

Intervention：

ring pessary with knob group (continence pessary)

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)：

 威爾士親王醫院 

单位级别：

  

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

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)：

 雅麗氏何妙齡那打素醫院 

单位级别：

  

Institution
hospital：

Alice Ho Miu Ling Nethersole Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Reduction in the PFDI Urinary Distress Inventory scores between both groups at 6 months and 12 months after treatment

指标类型：

主要指标

Outcome：

Reduction in the PFDI Urinary Distress Inventory scores between both groups at 6 months and 12 months after treatment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

1. Improvements of stress urinary incontinence using the Visual Analog Scale

指标类型：

次要指标

Outcome：

1. Improvements of stress urinary incontinence using the Visual Analog Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

2. Patients’ satisfaction on the vaginal pessaries using the Visual Analog Scale

指标类型：

次要指标

Outcome：

2. Patients’ satisfaction on the vaginal pessaries using the Visual Analog Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

3. Reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups

指标类型：

次要指标

Outcome：

3. Reduction in PFIQ Urinary Impact Questionnaire Domain scores between both groups

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

4. Changes in other domains of PFDI and PFIQ

指标类型：

次要指标

Outcome：

4. Changes in other domains of PFDI and PFIQ

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

5. Complications arising from vaginal pessaries

指标类型：

次要指标

Outcome：

5. Complications arising from vaginal pessaries

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：

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 99 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）：

Patients will be assigned to either ring pessary group or ring pessary with knob group with equal probability. Randomization will be carried out according to a computer-generated random number series in sequentially numbered, sealed opaque envelopes. The envelop will be prepared and kept by a research assistant

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

Patients will be assigned to either ring pessary group or ring pessary with knob group with equal probability. Randomization will be carried out according to a computer-generated random number series in sequentially numbered, sealed opaque envelopes. The envelop will be prepared and kept by a research assistant

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：

Double-blind. The envelop will be prepared and kept by a research assistant not involved in patient care. An independent gynaecologist who is not involved in the study will insert the vaginal pessary according to the allocation. Patients will not be informed the type of pessary to be inserted. Therefore, both the investigators and the patients are blinded to the treatment allocation.

Blinding：

Double-blind. The envelop will be prepared and kept by a research assistant not involved in patient care. An independent gynaecologist who is not involved in the study will insert the vaginal pessary according to the allocation. Patients will not be informed the type of pessary to be inserted. Therefore, both the investigators and the patients are blinded to the treatment allocation.

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）：

Not applicable

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

Not applicable

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 applicable

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

Not applicable

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-07-12 12:15:50
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