NCT03695822

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 24, 2018

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

March 7, 2019

Status Verified

May 1, 2018

Enrollment Period

28 days

First QC Date

October 1, 2018

Last Update Submit

March 5, 2019

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Bladder wall blood flow

    12 hours

Study Arms (1)

Mirabegron

EXPERIMENTAL

OAB female patients who will receive beta-3 agonist (mirabegron 2 mg) treatment

Drug: Mirabegron 25mg

Interventions

Mirabegron 25mgDRUG

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

Mirabegron

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All OAB female patients
  • \>20 years

You may not qualify if:

  • Allergy to mirabegron, urinary tract infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Interventions

mirabegron
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 4, 2018

Study Start

December 24, 2018

Primary Completion

January 21, 2019

Study Completion

January 31, 2019

Last Updated

March 7, 2019

Record last verified: 2018-05

Locations

TW(1)