Overactive bladder
Conditions
Interventions
None listed
Sponsors
N-QOL Study Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: At a tentative enrollment: obtained informed consent from a patient) (1) Female (2) 50 years of age or older (3) Don't wish to get pregnant (4) On OABSS*1, the both scores of Q2 (nocturia) and Q3 (sudden urge to urinate) are more than 2 points, respectively (5) Outpatients (6) Pathients who can answer to questionnaires, go to a bathroom/restroom and measure their urine volume by themselves (7) Patients who consent to study participation in writing (At an official enrollment: start prescription of mirabegron) (1) Urinate twice or more during nighttime, judging from patients' bladder diary (2) On OABSS, the score of Q3 and the total score are more than 2, more than 4, respectively *1: Overactive Bladder Symptom Score
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to mirabegron (2) Patients with a severe heart disease [Mirabegron might worsen the heart disease since some adverse reactions such as heart rate elevation by mirabegron have been reported] (3) Patients on medication with anti-arrhythmics, such as flecainide acetate or propafenone hydrochloride (4) Patients with long QT syndrome (5) Patients prone to occur arrhythmia such as severe bradycardia or acute myocardial ischemia (6) Patients who were taking anticholinergic drugs to treat OAB less than 3 months before study participation (7) Patients with hypokalemia (8) Patients with difficult-to-control hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg, in a seated position) (9) Patients with severe liver dysfunction (10) Patients with renal failure (11) Patients with glaucoma (12) Patients with urination difficulty (13) Patients with anuresis (14) Patients whose residual urinary volume during the observational period is more than 100 mL (15) Patients under treatment with placement of catheter or intermittent self-catheterization (16) Patients whose urinary volume is more than 40mL/kg a day on average (17) Patients complicated with urinary infection, urinary lithiasis or interstitial cystitis (18) Patients complicated with bladder tumor (19) Patients undergone surgical operation that might affect their urinary function within 6 months prior to study participation (20) Patients who received non-drug therapy such as electrical stimulation (low-frequency therapy and magnetic stimulation, for example), biofeedback procedure, bladder training or pelvic floor muscle exercise within 6 months prior to initiation of the observational period (21) Patients complied with/or with a history of mood disorder, psychoneurotic disorder or schizophrenia (22) Patients considered as ineligible for this study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes on frequency of urination at night on patients' bladder diary | — |
Countries
Japan
Contacts
Public ContactMomokazu Goto
Nagoya University Department of Urology, Nagoya University Graduate School of Medicine
Outcome results
None listed