UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients
Title of the study (Brief title)	Observational study to assess dose-up efficacy of anticholinergic agent on nocturia in overactive bladder patients(Dose Flex Study)
Region	Japan

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

Objectives
Narrative objectives1	To observe the change of nocturia symptom in OAB patients (IPSS Q7(nocturia score >=3))
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in IPSS Q7 (nocturia score) as change in nocturnal voids
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who are regarded as overactive bladder at the start of dosing imidafenacin 2)Patients who have the follow criteria even after administering imidafenacin for more than 4 weeks IPSS Q7(nocturia score) >=3 3)Aged >=20 years
Key exclusion criteria	1)Patients with contraindications for imidafenacin 2)Patients who have current condition of severe difficulty of urination 3)Patients who have history of urinary retention 4)Patients with serious kidney dysfunction 5)Residual urine volume > 50 mL 6)Patients with cancer in bladder, cystoliths, urinary tract infection, recurrent urinary tract infection or interstitial cystitis 7)Patients with polyuria 8)Patients who have administered prohibited substances or done prohibited therapy in the 4 weeks prior to the start of study (excepting operations on urinary and sexual organs) 9)Patients who have been operated on the urinary or sexual organs in the 6 months prior to the start of study 10)Patients with unstable lower urinary tract symptoms 11)Any other patients who are regarded as unsuitable for this study by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuyuki Suzuki
Organization	Tokyo Metropolitan Rehabilitation Hospital
Division name	Department of Medical Care
Address	2-14-1 Tutumidori Sumida-Ward, Tokyo
TEL	03-3616-8600
Email	ysuro@jikei.ac.jp

Public contact
Name of contact person	Yasuyuki Suzuki
Organization	Tokyo Metropolitan Rehabilitation Hospital
Division name	Department of Medical Care
Address	2-14-1 Tutumidori Sumida-Ward, Tokyo
TEL	03-3616-8600
Homepage URL
Email	ysuro@jikei.ac.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Kyorin Pharmaseutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 03 Day
Anticipated trial start date	2013 Year 12 Month 24 Day
Last follow-up date	2015 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2015 Year 07 Month 31 Day
Date analysis concluded	2015 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective observational study

Management information
Registered date	2013 Year 12 Month 20 Day
Last modified on	2016 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014771