UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017267 |
|---|---|
| Receipt number | 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 09:57:13 |
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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
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
kaki@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Renal and Urologic Surgery, Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010819
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
