Overactive bladder
Conditions
Interventions
treatment with mirabegron
Sponsors
Hokkaido University Graduate School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Postmenopausal patient 2.Patient who do not wish to have children at all 3.Patient who has an overactive bladder symptom score (OABSS) total score of 3 points and an OABSS Question 3 score of 2 points. 4.Outpatient 5.Pathient who can answer to questionnaires, and can walk to toilet unaided and measuring urine volume by him-/herself. 6.Patient Has personally given written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patient with a history of hypersensitivity to mirabegron 2.Patient 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.Patient taking flecainide acetate or propafenone hydrochloride. 4.Patient with long QT syndrome. 5.Patient who is vulnerable to arrhythmia such as bradycardia or acute myocardial ischemia. 6.Patient who has taken anticholinergic drugs to treat OAB less than 3 months before study participation 7.Patients with hypokalemia 8.Patient with uncontrolled hypertension (indicated by a systolic blood pressure [SBP] 180 mm Hg or diastolic blood pressure [DBP] 110 mm Hg measured in a sitting position 9.Patient with severe hepatic impairment 10.Patient with severe renal impairment 11. Patient with glaucoma 12.Patient with urination difficulty 13. Patient with anuresis 14. Patient whose residual urinary volume during the observational period is more than 100 mL 15.Patient with an indwelling catheter or practicing intermittent self-catheterization 16. Patient with polyuria, with the mean daily urine volume >= 40 mL/kg 17. Patient complicates with urinary tract infection, urinary calculus or interstitial cystitis, or who had a history of recurrent urinary tract infection 18.Patient complicates with bladder tumor 19.Patient has been undergone surgical operation that might affect their urinary function within 6 months prior to study participation 20.Patient who has 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.Patient with mood disorder, neurotic disorder or schizophrenia, or with a history of such. 22.Patient who is deemed otherwise unsuitable by the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison brain image between before- and after-treatment with mirabegron using PET | — |
Countries
Japan
Contacts
Public ContactTakeya Kitta
Hokkaido University Graduate School of Medicine Department of Renal and Genitourinary surgery
Outcome results
None listed