Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome
赞助:
Far Eastern Memorial Hospital
合作者:
信息的提供 (责任方):
Sheng-Mou Hsiao,Far Eastern Memorial Hospital
追踪信息 | |||
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首次提交日期 ICMJE | October 1, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | January 1, 2019 | ||
预计主要完成日期 | May 31, 2021 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Brief symptom rating scale[ Time Frame: 12 weeks ] The Brief symptom rating scale (BSRS) includes the following dimensions of psychopathology: somatic symptoms, obsessive-compulsive symptoms, interpersonal sensitivity, depressive symptoms, anxiety symptoms, hostility, phobic-anxiety, and paranoid tendency. Additional symptoms include vegetative and other clinical indicators. The BSRS is composed of 30 items rated on the basis of degree of distress caused by that item over the past week. Each dimension is assessed by several questions with a 5-point Likert scale (0-4 points). The severity of a psychopathologic factor is expressed with an index calculated from the sum of scores divided by the number of questions in that specific dimension. The General Symptom Index (GSI), a mean score of all BSRS items, represents the global severity of psychological distress (PD), and a higher GSI indicates more severe PD. The BSRS has been reported to be a reliable and valid psychiatric self-rating scale for use in psychosomatic research. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome | ||
正式标题 ICMJE | Far Eastern Memorial Hospital | ||
简要概况 | We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein. |
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详细说明 | Background/Purpose: Pharmacologic treatments for female overactive bladder syndrome (OAB) include antimuscarinics and beta-agonist. Similar efficacy has been reported between antimuscarinics and beta-agonist. Antimuscarinics has been found to be beneficial for patients with psychological distress. However, the impact of mirabegron on psychological distress in female OAB remains unknown. In addition, some animal studies found that beta-3 agonist can improve arterial blood flow, bladder ischemia and might improve bladder function; however, there is still lack of human study. Besides, c reactive protein was found to be elevated in female OAB. Nonetheless there is no study mentioning about the impact of mirabegron on c reactive protein. Thus, the aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | Phase 4 | ||
研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
60 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | May 31, 2021 | ||
预计主要完成日期 | May 31, 2021 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - All OAB female patients - >20 years Exclusion Criteria: - Allergy to mirabegron, urinary tract infections | ||
性别 |
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年龄 | 最小年龄:20 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Taiwan | ||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Sheng-Mou Hsiao,Far Eastern Memorial Hospital | ||
研究赞助商 ICMJE | Far Eastern Memorial Hospital | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Far Eastern Memorial Hospital | ||
验证日期 | May 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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