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

Far Eastern Memorial Hospital

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03695822
Enrollment
0
Registered
2018-10-04
Start date
2018-12-24
Completion date
2019-01-31
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome

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.

Interventions

The aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All OAB female patients * \>20 years

Exclusion criteria

* Allergy to mirabegron, urinary tract infections

Design outcomes

Primary

MeasureTime frameDescription
Brief symptom rating scale12 weeksThe 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

MeasureTime frameDescription
Bladder wall blood flow12 hoursvascularization index (VI) 、flow index (FI) and vascularization flow index (VFI)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026