Back to resultsImpact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome
Primary Purpose
Overactive Bladder Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Mirabegron 25mg
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
Eligibility Criteria
Inclusion Criteria:
- All OAB female patients
- >20 years
Exclusion Criteria:
- Allergy to mirabegron, urinary tract infections
Sites / Locations
- Far Eastern Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mirabegron
Arm Description
OAB female patients who will receive beta-3 agonist (mirabegron 2 mg) treatment
Outcomes
Primary Outcome Measures
Brief symptom rating scale
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 Outcome Measures
Bladder wall blood flow
vascularization index (VI) 、flow index (FI) and vascularization flow index (VFI)
Full Information
NCT ID
NCT03695822
First Posted
October 1, 2018
Last Updated
March 5, 2019
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03695822
Brief Title
Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome
Official Title
Far Eastern Memorial Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
I did not pass the 2018 Ministry of Science and Technology research project subsidy, so I applied for the project to close the case.
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirabegron
Arm Type
Experimental
Arm Description
OAB female patients who will receive beta-3 agonist (mirabegron 2 mg) treatment
Intervention Type
Drug
Intervention Name(s)
Mirabegron 25mg
Intervention Description
The aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.
Primary Outcome Measure Information:
Title
Brief symptom rating scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Bladder wall blood flow
Description
vascularization index (VI) 、flow index (FI) and vascularization flow index (VFI)
Time Frame
12 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All OAB female patients
>20 years
Exclusion Criteria:
Allergy to mirabegron, urinary tract infections
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Banqiao
State/Province
New Taipei
ZIP/Postal Code
22050
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome
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