Overactive Bladder
Conditions
Interventions
Mirabegron 12 weeks 50mg once a day
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1 Female patients with overactive bladder.(OABSS>2 and Q3>1) 2 Patients whom attending physician has determined to be reasonable for participation. 3 The contents of the questionnaire can be understood without the aid of others. 4 Patients who consent in writing.
Exclusion criteria
Exclusion criteria: (1)Patients who does not consent to this study. (2) Patients with retention within 12 months. (3)Patients whose residual urinary volume is more than 100 ml. (4) Patients with apparent neurogenic bladder. (5)Patients with bladder disease (bladder cancer, bladder stone, interstitial cystitis etc) (6)Patients with disease around bladder(endometriosis) (7)Patients with urinary tract infection, urinary calculus. (8)Patients with nycturia. (9)Patients with sleep disorder except the one with nycturia (sleep apnea syndrome, etc). (10) Patients with mental disorder. (11) Patients prescribed narcoleptic or medicine for mental disease. (12)Patients with difficulty in answering the questionnaire without the aid of others. (13)Patients under treatment with placement of catheter of intermittent self-catheterization. (14)Patients with circadia rhythm disorder, sift workers, an unsettled lifestyle. (15)Patients with uncontrollable angle-closure glaucoma (16)Patient with contraindications to mirabegron(with a history of hypersensitivity to mirabegron, with severe heart disease, on medication with anti-arrhythmics, such as flecainide acetate or propafenone hydrochloride, with long QT syndrome, with difficult-to-control hypertension, with urination difficulty, with severe liver or renal dysfunction) (17)Patients considered as ineligible for this study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes of 12weeks from baseline in OABSS | — |
Secondary
| Measure | Time frame |
|---|---|
| changes of 12 weeks from baseline in the following items. bladder diary, Questionnaire(IPSS, N-QOL, PSQI) parameters measured with Actiwatch | — |
Countries
Japan
Contacts
Public ContactYuka Toyama
Nippon Medical School Department of Urology
Outcome results
None listed