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

Phase 4

Withdrawn

• Conditions: Overactive Bladder Syndrome
• Interventions: Drug: Mirabegron 25mg

• Registration Number: NCT03695822
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Study Start: 2018-12-24
• Primary Completion: 2019-01-21
• Study Completion: 2019-01-31
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• All OAB female patients
• >20 years

Exclusion Criteria

• Allergy to mirabegron, urinary tract infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mirabegron	Mirabegron 25mg	OAB female patients who will receive beta-3 agonist (mirabegron 2 mg) treatment

Primary Outcome Measures

Name	Time	Method
Brief symptom rating scale	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 Outcome Measures

Name	Time	Method
Bladder wall blood flow	12 hours	vascularization index (VI) 、flow index (FI) and vascularization flow index (VFI)

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan