UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the safety and efficacy of anticolinergics for children with overactive bladder
Title of the study (Brief title)	Study on the safety and efficacy of anticholinergics for pediatric overactive bladder
Region	Japan

Condition
Condition	Pediatric overactive bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety and efficacy of anticholinergics for children with overactive bladder
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The number of days with diurnal urinary incontinence for one week just before visit to clinics
Key secondary outcomes	Overactive bladder symptom score (OABSS), Dysfunctional voiding scoring system, Postvoid residual urine, Intelligence test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Solifenacin 2.5-5mg once daily
Interventions/Control_2	Propiverine 10-20mg once daily
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	5 years-old <=
Age-upper limit	16 years-old >
Gender	Male and Female
Key inclusion criteria	Diurnal urinary incontinence episode once or more for one week, and diurnal urinary incontinence score one or gerater and sum score of diurnal urinary incontinence, holdng posture and urgency urinary incontinence 3 or greater on dysfunctional voiding scoring system
Key exclusion criteria	Voiding dysfunction, Constipation, Postvoid residual urine 50ml or greater, Bladder outlet obstruction, Congenital lower urinary tract anomaly, Polyuria
Target sample size	150

Research contact person
Name of lead principal investigator	Hidehiro Kakizaki
Organization	Asahikawa Medical University Hospital
Division name	Department of Renal and Urologic Surgery
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, 078-8510, Japan
TEL	0166-68-2533
Email	kaki@asahikawa-med.ac.jp

Public contact
Name of contact person	Hidehiro Kakizaki
Organization	Asahikawa Medical University Hospital
Division name	Department of Renal and Urologic Surgery
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, 078-8510, Japan
TEL	0166-68-2533
Homepage URL
Email	kaki@asahikawa-med.ac.jp

Sponsor
Institute	Department of Renal and Urologic Surgery, Asahikawa Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	旭川医科大学病院、市立甲府病院、新潟大学病院、千葉県こども病院、信州大学病院、関西医科大学附属枚方病院、北海道大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 21 Day
Anticipated trial start date	2012 Year 04 Month 25 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 11 Month 30 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 08 Month 21 Day

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

Management information
Registered date	2015 Year 04 Month 24 Day
Last modified on	2018 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010819