Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.
Condition: Overactive Bladder (OAB)
MeSH terms: Urinary Bladder, Overactive
Intervention: Mirabegron tablet; Solifenacin tablet; Propiverine tablet; Imidafenacin tablet; Tolterodine capsule
Intervention description: orally administered at a dose of 1 tablet once daily after breakfast; orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 2 tablets); orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 1 tablet twice daily after breakfast and after dinner); orally administered at a dose of 1 tablet (0.1 mg tablet) twice daily after breakfast and after dinner (could be increased to 2 tablets twice daily after breakfast and after dinner); orally administered at a dose of 1 capsule once daily after breakfast (could not be increased)
Intervention MeSH terms: Mirabegron; Solifenacin Succinate; Tolterodine Tartrate; Propiverine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 649.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Anticholinergic; Overactive Bladder (OAB); Mirabegron; YM178

Summary:

      The objective of the study was to evaluate the safety and efficacy of add-on therapy with
      anticholinergics in patients with OAB on mirabegron.
    

Eligibility criteria:

        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