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【ChiCTR1900021044】激光療法用於處理華人婦女壓力性小便失禁問題之隨機研究

基本信息
登记号

ChiCTR1900021044

试验状态

正在进行

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2018-12-18

临床申请受理号

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靶点

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适应症

婦女壓力性小便失禁

试验通俗题目

激光療法用於處理華人婦女壓力性小便失禁問題之隨機研究

试验专业题目

激光療法用於處理華人婦女壓力性小便失禁問題之隨機研究

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

To compare the efficacy of vaginal laser treatment for women with SUI as compared to control, based on reduction in scores on health related quality of life (PFDI-UDI Stress Subscale), subjective outcome of symptoms improvement, urinary diary, VAS, other scores of health related quality of life.

试验分类
试验类型

随机平行对照

试验分期

治疗新技术

随机化

Permuted-block randomization in 2:1 ratio of treatment group:control group, with block size of 3

盲法

Single-blind for Trial subjects

试验项目经费来源

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

试验范围

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目标入组人数

75

实际入组人数

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第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

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入选标准

1. Women aged over 18 years; 2. Patients diagnosed with urodynamic stress incontinence (USI); 3. Willing to give written consent and compliance to participate in the study.;

排除标准

1. Patients with mixed urinary incontinence with predominant urge urinary incontinence; 2. Patients who had recurrent USI that failed previous surgical treatment, e.g. tension free vaginal tape surgery or injection of bulking agent; 3. Patients with pregnancy or lactating; 4. Patients with stage II or above pelvic organ prolapse; 5. Patients with undiagnosed vaginal bleeding, injury or active infection; 6. Patients currently in-use of photosensitive drugs; 7. Patients refuse to participate in the study.;

研究者信息
研究负责人姓名
试验机构

香港中文大學威爾斯親王醫院婦產科學系

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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