Status:
COMPLETED
Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Overactive Bladder (OAB)
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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.
Detailed Description
This was a multicenter, open-label study to evaluate the safety and efficacy of add-on therapy with antimuscarinics in patients with OAB treated with mirabegron. The total duration of the study perio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2016
Estimated Enrollment :
649 Patients enrolled
Trial Details
Trial ID
NCT02294396
Start Date
October 28 2014
End Date
September 7 2016
Last Update
October 31 2024
Active Locations (7)
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1
Chugoku, Japan
2
Chūbu, Japan
3
Hokkaido, Japan
4
Kansai, Japan