UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Title of the study (Brief title)	Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).
Region	Japan

Condition
Condition	Overactive bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We assess the efficacy and tolerability after 12 weeks treatment with mirabegron or imidafenacin in postmenopausal female patients with OAB.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of total overactive bladder symptom score (OABSS)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Mirabegron 50 mg is orally administered once daily for 12 weeks.
Interventions/Control_2	Imidafenacin 0.1 mg is orally administered twice daily for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	200

Research contact person
Name of lead principal investigator	Seiichiro Ozono
Organization	Hamamatsu University School of Medicine
Division name	Department of Urology
Address	1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2306
Email	oznsei@hama-med.ac.jp

Public contact
Name of contact person	Atsushi Otsuka
Organization	Hamamatsu University School of Medicine
Division name	Department of Urology
Address	1-20-1, handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2306
Homepage URL
Email	otsuka@hama-med.ac.jp

Sponsor
Institute	Department of Urology, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	浜松医科大学病院（静岡県）

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 30 Day
Anticipated trial start date	2013 Year 03 Month 21 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 05 Month 20 Day
Date trial data considered complete	2015 Year 05 Month 31 Day
Date analysis concluded	2015 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 26 Day
Last modified on	2016 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012083