Overactive BladderPhase 4NCT02468375
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 Phase 4 study testing mirabegron 50mg in people with Overactive Bladder, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- mirabegron 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <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
Who cannot join
- <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.
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Overactive Bladder
- Being tested
- mirabegron 50mg
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegron 50mgDrug
Also called Betamiga tablet
434 OAB patient intake mirabegron 50mg/day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| mirabegron 50mg | Experimental | about 434 OAB patients intake mirabegrone 50mg/day for 12 weeks. Receives: Drug: mirabegron 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfation Questionnaire
Measured: at the end of the treatment( 12weeks)
Secondary outcomes (7)
micturtion change
Measured: 4weeks, 12weeks
urgency change
Measured: 4weeks, 12weeks
incontinence change
Measured: 4weeks. 12weeks
OABq-SF score change
Measured: 4weeks, 12weeks
OABSS score change
Measured: 4weeks, 12weeks
Global Response Assessment(GRA) score change
Measured: 4weeks, 12weeks
Willingness to continue Questions
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468375
- Sponsor's protocol ID
- 2015-02-052
- Status last verified
- Jun 2015
- First submitted
- 7 Jun 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02468375
- Acronym / sponsor ID
- 2015-02-052
- Conditions
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mirabegron 50mg | Experimental | Drug: mirabegron 50mgabout 434 OAB patients intake mirabegrone 50mg/day for 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- <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.
Key exclusion criteria (19 listed)
- <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirabegron 50mgAlso: Betamiga tablet434 OAB patient intake mirabegron 50mg/day for 12 weeks. | Drug | mirabegron 50mg |
Primary outcome
Treatment Satisfation Questionnaire
Time frame: at the end of the treatment( 12weeks)
7 secondary outcomes
micturtion change
Time frame: 4weeks, 12weeks
urgency change
Time frame: 4weeks, 12weeks
incontinence change
Time frame: 4weeks. 12weeks
OABq-SF score change
Time frame: 4weeks, 12weeks
OABSS score change
Time frame: 4weeks, 12weeks
Global Response Assessment(GRA) score change
Time frame: 4weeks, 12weeks
Willingness to continue Questions
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mirabegron 50mg in people with Overactive Bladder, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfation Questionnaire (time frame: at the end of the treatment( 12weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.