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

• Status: Completed
• Trial end date: 2016-09-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Cholinergic Antagonists; Mirabegron; Propiverine; Solifenacin Succinate; Tolterodine Tartrate

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