UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025303 |
|---|---|
| Receipt number | R000029033 |
| Scientific Title | Will silicon urinary catheter prevent Catheter Related Bladder Discomfort after anesthesia? compared with latex urinary catheter for equal urine drainage function. |
| Date of disclosure of the study information | 2016/12/16 |
| Last modified on | 2017/07/03 15:05:54 |
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Basic information
Public title
Will silicon urinary catheter prevent Catheter Related Bladder Discomfort after anesthesia?
compared with latex urinary catheter for equal urine drainage function.
Acronym
Will silicon urinary catheter prevent Catheter Related Bladder Discomfort after anesthesia?
compared with latex urinary catheter for equal urine drainage function.
Scientific Title
Will silicon urinary catheter prevent Catheter Related Bladder Discomfort after anesthesia?
compared with latex urinary catheter for equal urine drainage function.
Scientific Title:Acronym
Will silicon urinary catheter prevent Catheter Related Bladder Discomfort after anesthesia?
compared with latex urinary catheter for equal urine drainage function.
Region
| Japan |
Condition
Condition
Catheter Related Bladder DIscomfort
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Find out will silicon urinary catheter prevent Catheter Related Bladder Discomfort (CRBD) after anesthesia compared with latex urinary catheter for equal urine drainage function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of Catheter Related Bladder Discomfort (CRBD)
(before exiting operation room and every 24h till the urinary catheter removed)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Insert silicon urinary catheter after general anesthesia.
Keep inserted as much as needed after operation.
Interventions/Control_2
Insert latex urinary catheter after general anesthesia.
Keep inserted as much as needed after operation.
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
Patient undergoing respiratory surgery, upper abdominal surgery and spinal surgery.
Key exclusion criteria
Bladder outflow obstruction, over activate bladder, diabetes mellitus, Parkinson's disease, Dementia, and chronic opioid use.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Ide |
Organization
Kimitsu chuuou Hospital
Division name
Department of anesthesia
Zip code
Address
1010, Sakurai, Kisarazu city, Prefecture of Chiba, Japan
TEL
0438-36-1071
simple_style_ak@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ide |
Organization
Kimitsu chuuou Hospital
Division name
Department of anesthesia
Zip code
Address
1010, Sakurai, Kisarazu city, Prefecture of Chiba, Japan
TEL
0438-36-1071
Homepage URL
simple_style_ak@yahoo.co.jp
Sponsor or person
Institute
Kimitsu chuuou Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029033
