Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
- Conditions
- Overactive bladder
- Registration Number
- JPRN-UMIN000010321
- Lead Sponsor
- Department of Urology, Hamamatsu University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 200
Not provided
1)Premenopausal women 2)Demonstrable stress urinary incontinence 3)Post-void residual urine volume is more than 100mL, or presence of previous bladder outlet obstruction (BOO) 4)Patients with obvious inflammation, urinary tract infection, urolithiasis or malignant disease of the pelvic organs 5)Patients who have administered prohibited substances 6)Patients with previous pelvic radiation or surgery. 7)Patients who have received prohibited therapy 8)Patients who have contraindication of anticholinergic agents or Mirabegron 9)Patients with severe hepatic or renal dysfunction 10)Patients who have allergies for anticholinergic or beta-adrenergic agents 11)Patients who have received anticholinergic or beta-adrenergic agents within 12 months 12)Patients with severe cardiac dysfunction 13)Patients with arrhythmia 14)Patients with hypokalemia 15)Patients with polyuria 16)Any other patients whom the attending physician considered ineligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of total overactive bladder symptom score (OABSS)
- Secondary Outcome Measures
Name Time Method