Back to resultsProspective 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.
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mirabegron 50mg
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
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,
1) 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. 6-1. subject who has intake Alpha-blocker, Diabetes insipidus medication, PDE5 inhibitor(for BPH Tx), SSRI within 12weeks prior to Screening.
6-2. subject who has started, stopped or changed the dose of 5-Alpha Reductase Inhibitors(5-ARI) within 4 weeks prior to Screening.
6-3. 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.
- subject has known or suspected hypersensitivity to Beta 3 adrenalin receptor agonist.
- subject has clinically significant cardiovascular diseases hepatic diseases renal diseases immunization diseases lung diseases and cancer.
- subject who has planed pregnency, breast feeding during clinical trial period.
<BASELINE> voiding volume over 3000ml per day. post voiding residual volume over 200ml
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mirabegron 50mg
Arm Description
about 434 OAB patients intake mirabegrone 50mg/day for 12 weeks.
Outcomes
Primary Outcome Measures
Treatment Satisfation Questionnaire
Secondary Outcome Measures
micturtion change
urgency change
incontinence change
OABq-SF score change
OABSS score change
Global Response Assessment(GRA) score change
Willingness to continue Questions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02468375
Brief Title
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.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
434 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mirabegron 50mg
Arm Type
Experimental
Arm Description
about 434 OAB patients intake mirabegrone 50mg/day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
mirabegron 50mg
Other Intervention Name(s)
Betamiga tablet
Intervention Description
434 OAB patient intake mirabegron 50mg/day for 12 weeks.
Primary Outcome Measure Information:
Title
Treatment Satisfation Questionnaire
Time Frame
at the end of the treatment( 12weeks)
Secondary Outcome Measure Information:
Title
micturtion change
Time Frame
4weeks, 12weeks
Title
urgency change
Time Frame
4weeks, 12weeks
Title
incontinence change
Time Frame
4weeks. 12weeks
Title
OABq-SF score change
Time Frame
4weeks, 12weeks
Title
OABSS score change
Time Frame
4weeks, 12weeks
Title
Global Response Assessment(GRA) score change
Time Frame
4weeks, 12weeks
Title
Willingness to continue Questions
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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,
1) 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. 6-1. subject who has intake Alpha-blocker, Diabetes insipidus medication, PDE5 inhibitor(for BPH Tx), SSRI within 12weeks prior to Screening.
6-2. subject who has started, stopped or changed the dose of 5-Alpha Reductase Inhibitors(5-ARI) within 4 weeks prior to Screening.
6-3. 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.
subject has known or suspected hypersensitivity to Beta 3 adrenalin receptor agonist.
subject has clinically significant cardiovascular diseases hepatic diseases renal diseases immunization diseases lung diseases and cancer.
subject who has planed pregnency, breast feeding during clinical trial period.
<BASELINE> voiding volume over 3000ml per day. post voiding residual volume over 200ml
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul,
ZIP/Postal Code
130-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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.
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