Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.

This is an interventional treatment trial for Overactive Bladder (OAB) focused on measuring Anticholinergic, Overactive Bladder (OAB), Mirabegron, YM178 Read More

Inclusion Criteria:

• Female: OAB outpatient who had been postmenopausal for at least 1 year
• Male: OAB outpatient who had no wish to have children in the future
• Patient had been under treatment with mirabegron at a stable dose of 50 mg once daily for at least 6 weeks before the start of the screening period
• Patient capable of walking to the bathroom without assistance
• Patient had a total Overactive Bladder Symptom Score (OABSS) of ≥3 points and a Question 3 score of ≥2 points

Exclusion Criteria:

• Patient had an established diagnosis of stress urinary incontinence (patient had no symptom other than stress urinary incontinence)
• Patient had urinary tract infection (cystitis, prostatitis, etc.), urinary calculus (ureteric calculus, urethral calculus, bladder calculus, etc.), interstitial cystitis, or a history of recurrent urinary tract infection (at least 3 episodes within 24 weeks before the start of the screening period)
• Patient had a residual urine volume of ≥100 mL at week -2 visit or patient with benign prostatic hyperplasia or lower urinary tract obstruction
• Patient had uncontrolled hypertension (sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg at week -2 visit)
• Patient had a pulse rate of ≥110 bpm or <50 bpm at week -2 visit
• Patient had a contraindication to antimuscarinics (urinary retention; obstruction in thepylorus, duodenum, or intestine; paralytic ileus; gastric/intestinal atony; myasthenia gravis; and decreased gastrointestinal motility/tone, etc.)
• Patient had glaucoma, ulcerative colitis, hyperthyroidism, dementia, cognitive dysfunction, parkinsonism symptoms, or clinically significant cerebrovascular disorder
• Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had a history of malignant tumor (except for malignant tumor that had not been treated for at least 5 years before the start of the screening period with no risk of recurrence)
• Patient had drug hypersensitivity to β-agonists or anticholinergics
• Patient was under treatment with flecainide acetate or propafenone hydrochloride
• Patient had long QT syndrome, patient was vulnerable to arrhythmia such as bradycardia or acute myocardial ischemia, patient had hypokalemia, and patient had ischemic heart disease such as angina pectoris
• Patient had used any prohibited concomitant medication within 4 weeks before the start of the screening period
• Patient was under catheterization or intermittent self-catheterization or patient had pelvic organ prolapse that affected the urinary tract function
• Patient had received radiotherapy that affected the urinary tract function
• Patient had received surgical therapy that may have affected the urinary tract function within 24 weeks before the start of the screening period
• Patient had received nonpharmacological therapy for OAB such as electric stimulation therapy (interferential low frequency therapy, magnetic stimulation therapy, etc.), biofeedback therapy, bladder training, or pelvic floor muscle exercise within 2 weeks before the start of the screening period
• Patient had or had a history of mood disorder, neurotic disorder, and schizophrenia