Unique ID issued by UMIN | UMIN000010321 |
---|---|
Receipt number | R000012083 |
Scientific Title | Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study). |
Date of disclosure of the study information | 2013/03/26 |
Last modified on | 2016/09/26 15:15:20 |
Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Japan |
Overactive bladder
Urology |
Others
NO
We assess the efficacy and tolerability after 12 weeks treatment with mirabegron or imidafenacin in postmenopausal female patients with OAB.
Efficacy
Change of total overactive bladder symptom score (OABSS)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Mirabegron 50 mg is orally administered once daily for 12 weeks.
Imidafenacin 0.1 mg is orally administered twice daily for 12 weeks.
20 | years-old | <= |
Not applicable |
Female
1)OAB patients (urgency score >= 2 and total score >= 3 in overactive bladder symptom score [OABSS]).
2)Twenty year-old or more patients
3)Postmenopausal women
4)Patients from whom we received written informed consent
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
200
1st name | |
Middle name | |
Last name | Seiichiro Ozono |
Hamamatsu University School of Medicine
Department of Urology
1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
053-435-2306
oznsei@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Atsushi Otsuka |
Hamamatsu University School of Medicine
Department of Urology
1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
053-435-2306
otsuka@hama-med.ac.jp
Department of Urology, Hamamatsu University School of Medicine
Astellas Pharma Inc.
Profit organization
Japan
NO
浜松医科大学病院(静岡県)
2013 | Year | 03 | Month | 26 | Day |
Published
Completed
2013 | Year | 01 | Month | 30 | Day |
2013 | Year | 03 | Month | 21 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 20 | Day |
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 08 | Month | 31 | Day |
2013 | Year | 03 | Month | 26 | Day |
2016 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012083