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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017267
Receipt No. R000010819
Scientific Title Study on the safety and efficacy of anticolinergics for children with overactive bladder
Date of disclosure of the study information 2015/04/24
Last modified on 2018/10/26

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Basic information
Public title Study on the safety and efficacy of anticolinergics for children with overactive bladder
Acronym Study on the safety and efficacy of anticholinergics for pediatric overactive bladder
Scientific Title Study on the safety and efficacy of anticolinergics for children with overactive bladder
Scientific Title:Acronym 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
1st name
Middle name
Last name Hidehiro Kakizaki
Organization Asahikawa Medical University Hospital
Division name Department of Renal and Urologic Surgery
Zip code
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
1st name
Middle name
Last name Hidehiro Kakizaki
Organization Asahikawa Medical University Hospital
Division name Department of Renal and Urologic Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 03 Month 21 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010819

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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