UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005374 |
|---|---|
| Receipt number | R000006378 |
| Scientific Title | Combinational effect of clenbuterol chloride and anticholinergic drugs on female stress and mixed urinary incontinence |
| Date of disclosure of the study information | 2011/04/04 |
| Last modified on | 2011/04/04 15:05:01 |
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Basic information
Public title
Combinational effect of clenbuterol chloride and anticholinergic drugs on female stress and mixed urinary incontinence
Acronym
Combinational effect of clenbuterol chloride and anticholinergic drugs on female stress and mixed urinary incontinence
Scientific Title
Combinational effect of clenbuterol chloride and anticholinergic drugs on female stress and mixed urinary incontinence
Scientific Title:Acronym
Combinational effect of clenbuterol chloride and anticholinergic drugs on female stress and mixed urinary incontinence
Region
| Japan |
Condition
Condition
female stress and mixed urinary incontinence
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Combinational effect of clenbuterol chloride and anticholinergic drugs on female stress and mixed urinary incontinence
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
question
Key secondary outcomes
record of urination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
anticholinergic drugs
Interventions/Control_2
anticholinergic drugs and clenbuterol chloride
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
Female
Key inclusion criteria
female stress and mixed urinary incontinence
Key exclusion criteria
.urinary incontinence
.polyuria
.severe chronic constipation
.pregnant woman
.the lactation period
.contraindication for the two drugs
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ISHIKO OSAMU |
Organization
osaka city university medical hospital
Division name
obsterictis and gynecology
Zip code
Address
1-5-7asahimachi abenoku osaka
TEL
06-6645-3862
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
osaka city university medical hospital
Division name
obsterictis and gynecology
Zip code
Address
TEL
06-6645-3862
Homepage URL
Sponsor or person
Institute
osaka city university graduate school of medicine, obsterictis and gynecology
Institute
Department
Personal name
Funding Source
Organization
osaka city university graduate school of medicine, obsterictis and gynecology
Organization
Division
Category of Funding Organization
Other
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
大阪市立大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 04 | Day |
Last modified on
| 2011 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006378
