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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025303
Receipt No. 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

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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
Email 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
Email simple_style_ak@yahoo.co.jp

Sponsor
Institute Kimitsu chuuou Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029033

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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