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.
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.
1 other identifier
interventional
434
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 7, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 28, 2018
June 1, 2015
2.3 years
June 7, 2015
February 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Satisfation Questionnaire
at the end of the treatment( 12weeks)
Secondary Outcomes (7)
micturtion change
4weeks, 12weeks
urgency change
4weeks, 12weeks
incontinence change
4weeks. 12weeks
OABq-SF score change
4weeks, 12weeks
OABSS score change
4weeks, 12weeks
- +2 more secondary outcomes
Study Arms (1)
mirabegron 50mg
EXPERIMENTALabout 434 OAB patients intake mirabegrone 50mg/day for 12 weeks.
Interventions
434 OAB patient intake mirabegron 50mg/day for 12 weeks.
Eligibility Criteria
You may qualify if:
- \<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
You may not qualify if:
- \<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. 6-1. 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.
- subject who has Non-drug treatment including bladder training, pelvic floor muscle training within 12 weeks prior to Screening.
- subject has severe hypertension which is defined as a sitting average systolic blood pressure over 180 mmHg, and/or diastolic blood pressure over 11 0mmHg.
- pulse over 100 bpm or below 50 bpm.
- subject has an indwelling catheter or practices intermittent self-catheterization.
- subject who had surgery which can influence urinary track function (ex, TURP, Laser treatment,etc.).
- subject who had complication of urinary tract infection, urinary stone, interstitial cystitis, or recurrent UTI history.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 130-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyu-Sung Lee, Ph.D
Samsung Medical Center
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
- professor
Study Record Dates
First Submitted
June 7, 2015
First Posted
June 10, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
February 28, 2018
Record last verified: 2015-06