Samsung Medical Center
Seoul, 130-710, South Korea
NCT Number: NCT02468375
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.
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Notify Me20 year and older
All sexes
Interventional
Phase 4
Seoul, 130-710, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
<SCREENING>
<BASELINE> Voiding Diary for 3 days
Exclusion criteria
<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.
<BASELINE> voiding volume over 3000ml per day. post voiding residual volume over 200ml
434 OAB patient intake mirabegron 50mg/day for 12 weeks.
Other names: Betamiga tablet
Time frame: at the end of the treatment( 12weeks)
Time frame: 4weeks, 12weeks
Time frame: 4weeks, 12weeks
Time frame: 4weeks. 12weeks
Time frame: 4weeks, 12weeks
Time frame: 4weeks, 12weeks
Time frame: 4weeks, 12weeks
Time frame: 12 weeks
Samsung Medical Center
Other
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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