UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of anticholinergic agents applied for day-time or night-time
Title of the study (Brief title)	Efficacy and safety of anticholinergic agents applied for day-time or night-time
Region	Japan

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

Objectives
Narrative objectives1	The aim of study is to examine efficacy and safety of Detrusitol, an anticholinergic agent, applied for day-time or night-time.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The presence of dry mouth induced by Detrusitol, an anticholinergic agent, applied for day-time or night-time will be investigated.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Detrusitor
Interventions/Control_2
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with overactive bladder
Key exclusion criteria	1.Urinary retention has occured through the latest 1 year. 2.Post voied residual urine volume is more than 100ml. 3.The treatment has been already done. 4.Patients have sleep disturbance. 5.Patients have irregular life styles. 6.Patients have inhibited diseases for the use of anticholinergic agents.
Target sample size	100

Research contact person
Name of lead principal investigator	Akira Furuta
Organization	Jikei University School of Medicine
Division name	Urology
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	a-furuta@jikei.ac.jp

Public contact
Name of contact person	Akira Furuta
Organization	Jikei University School of Medicine
Division name	Urology
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	a-furuta@jikei.ac.jp

Sponsor
Institute	Jikei University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	東京慈恵会医科大学附属病院泌尿器科、第三病院泌尿器科、柏病院泌尿器科、青戸病院泌尿器科

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 03 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2012 Year 10 Month 30 Day
Date of closure to data entry	2012 Year 12 Month 31 Day
Date trial data considered complete	2012 Year 12 Month 31 Day
Date analysis concluded	2013 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	There were no significant differences between the nighttime and daytime treatment of tolterodine in terms of the adverse events such as thirsty in OAB patients. However, the limitation of this study is a few registrated number of patient (n=10), so that further stufy will be needed to clalify this point.
Other related information	None

Management information
Registered date	2011 Year 09 Month 28 Day
Last modified on	2016 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007618