Overactive bladder
Conditions
Interventions
Imidafenacin 0.1mg will be orally administered twice a day, once after breakfast and dinner for 12 weeks. For patients who are insufficient in 12 weeks, Mirabegron 50mg will be orally administered on
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Treatment 1 1)OAB patients (urgency score (OABSS) >= 2 and nighttime frequency score >= 2) 2)Outpatients 3)20 years old or more patients 4)Postmenopausal women 5)Patients from whom we have received written consent. Treatment 2 1)OAB patients (urgency score (OABSS) >= 2 and nighttime frequency score >= 2) 2)Patients who are insufficient in 12 weeks (not improved 3 scores in OABSS total) 3)Patients from whom we have received consent
Exclusion criteria
Exclusion criteria: 1)Patients who has contraindication of Imidafenacin 2)Patients who has contraindication of Mirabegron 3)Patients with urinary flow decreased 4)Patients with history of urinary retention 5)Patients with arrhythmia 6)Patients with hypokalemia 7)Patients with serious kidney dysfunction 8)Residual urine volume is more than 100mL 9)Patients with bladder cancer, urinary tract stones, symptomatic urinary tract infection, recurrent urinary tract infection and interstitial cystitis. 10)Patients with polyuria 11)Patients who have administered prohibited substances or done prohibited therapy within the 4 weeks before enrollment 12)Patients who have a urology or genital surgery within the 6 months before enrollment 13)Patients with history of resistance to anti-holinergic agents 14)Lower urinary tract symptoms aren't stable. 15)Any other patients who are regarded as unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of total OABSS score | — |
Countries
Japan
Contacts
Public ContactMasayuki Takeda
University of Yamanashi Department of Urology, School of Medicine
Outcome results
None listed