A Multicenter Prospective Study for Patient Perception of Treatment Satisfaction After Switching to Mirabegron in Patients With Overactive Bladder Who Were Unsatisfied With Efficacy of Antimuscarinic Therapy or Adverse Event.

Samsung Medical Center1 site in 1 country434 target enrollmentJune 2015

ConditionsOveractive Bladder

Interventionsmirabegron 50mg

Drugsmirabegron 50mg

Overview

Phase: Phase 4
Intervention: mirabegron 50mg
Conditions: Overactive Bladder
Sponsor: Samsung Medical Center
Enrollment: 434
Locations: 1
Primary Endpoint: Treatment Satisfation Questionnaire
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to measure the treatment satisfaction after switching to mirabegron in patient with Overactive Bladder(OAB) who were unsatisfied with efficacy of antimuscarinic therapy or adverse event.

Patient will take the mirabegron 50mg/day for 12 weeks, and the satisfation of the therapy will be measured with Treatment Satisfaction Questionnaire(TSQ), Global Response Assessment(GRA), OAB-q short form, OAB Symptom Score and Willingness to continue Questions.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

KYU-SUNG LEE

professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•\<SCREENING\>
•over 20 years old, who has overactive bladder at least for 3 months.
•total OABSS score over 3 points, and number 3 question score should be over 2 points.
•if one of the criteria met,
•efficacy : who are unsatisfied with antimuscarinics during the past 2 years. (should be treated at least 8 weeks) 2) adverse event(AE) : who are unsatisfied with antimuscarinics treatment due to AE(dry mouth, constipation, etc) 4.subject who can write voiding diary. 5.subject who can understand about the study and sign the informed concent form.
•\<BASELINE\> Voiding Diary for 3 days
•micturition 8/day
•urgency 2/day

Exclusion Criteria

•\<SCREENING\>
•subject has history or risk of acute urinary retension.
•subject has prostate cancer.
•subject has lower urinary tract obstruction and judge by investigator that the subject is not appropriate to participate in this study.
•subject has a previous or current bladder tumor.
•subject has significant stress incontinence or mixed incontinence where stress is the dominant factor.
•prohibitied, permitted medication. 6-
•subject who has intake Alpha-blocker, Diabetes insipidus medication, PDE5 inhibitor(for BPH Tx), SSRI within 12weeks prior to Screening.
•subject who has started, stopped or changed the dose of 5-Alpha Reductase Inhibitors(5-ARI) within 4 weeks prior to Screening.
•Subject who currently intake Antimuscarinics, Antihistamines, Beta 2-adrenoreceptor agonist, loop diuretics,CYP2D6 substrates with narrow therapeutic index, CYP3A4 inducing agent, CYP 3A4 inhibitor, Antifungal agent, Antiarrythmic drugs.