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Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome

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合作者:
信息的提供 (责任方):
Sheng-Mou Hsiao,Far Eastern Memorial Hospital
October 1, 2018
October 4, 2018
October 5, 2018
January 1, 2019
May 31, 2021   (主要结果测量的最终数据收集日期)
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.

与当前相同
  • Bladder wall blood flow[ Time Frame: 12 hours ]
    vascularization index (VI) 、flow index (FI) and vascularization flow index (VFI)
 
Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome
Far Eastern Memorial Hospital

We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein.

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.
Interventional
Phase 4
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
  • Drug: Mirabegron 25mg
    The aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.
  • Experimental: Mirabegron
    OAB female patients who will receive beta-3 agonist (mirabegron 2 mg) treatment
 
Not yet recruiting
60
与当前相同
May 31, 2021
May 31, 2021   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - All OAB female patients - >20 years Exclusion Criteria: - Allergy to mirabegron, urinary tract infections
参与研究的性别: Female
最小年龄:20 Years ,最大年龄:N/A  
没有
Taiwan
 
Yes
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
计划分享 IPD:
Sheng-Mou Hsiao,Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
:
Far Eastern Memorial Hospital
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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