Far Eastern Memorial Hospital
Overview
- Phase
- Phase 4
- Intervention
- Mirabegron 25mg
- Conditions
- Overactive Bladder Syndrome
- Sponsor
- Far Eastern Memorial Hospital
- Locations
- 1
- Primary Endpoint
- Brief symptom rating scale
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein.
Detailed Description
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.
Investigators
Sheng-Mou Hsiao
Chief, Department of Obstetrics & Gynecology
Far Eastern Memorial Hospital
Eligibility Criteria
Inclusion Criteria
- •All OAB female patients
- •\>20 years
Exclusion Criteria
- •Allergy to mirabegron, urinary tract infections
Arms & Interventions
Mirabegron
OAB female patients who will receive beta-3 agonist (mirabegron 2 mg) treatment
Intervention: Mirabegron 25mg
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Bladder wall blood flow(12 hours)