UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019454 |
|---|---|
| Receipt number | R000022500 |
| Scientific Title | RCT study on non-sterilized glove use at cystoscopy |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2022/10/03 09:08:40 |
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Basic information
Public title
RCT study on non-sterilized glove use at cystoscopy
Acronym
RCT on non-steriliezd glove at cystoscopy
Scientific Title
RCT study on non-sterilized glove use at cystoscopy
Scientific Title:Acronym
RCT on non-steriliezd glove at cystoscopy
Region
| Japan |
Condition
Condition
patients consulting urologic offices, who require cystoscopy
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
assessment of safety of non-steriliezd gloves
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of symptomatic urological infection during 2 weeks after cystoscopy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Male and Female
Key inclusion criteria
adult patients, who require cystoscopy examination
Key exclusion criteria
1)patients who cannot understand the purpose of cystoscopy
2)patients who have previous history of symptomatic urologic infection after cystoscopy
3)patients who undertake some procedures under cystoscopy, such as biopsy
4)patients who have risks of urologic or other bacterial infection
5)pateints who are considered not appropriate by doctors
Target sample size
4600
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Nakashima |
Organization
Shizuoka General Hospital
Division name
urology
Zip code
420-8527
Address
4-27-1, Kitaando, Aoi-ku, Shizuoka
TEL
054-247-6111
naka_yoshi_uro@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Maejima |
Organization
Shizuoka General Hospital
Division name
Clinical research control
Zip code
420-8527
Address
4-27-1, Kitaando, Aoi-ku, Shizuoka
TEL
054-247-6111
Homepage URL
chiken-sougou@shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Ethical committee of Shizuoka General Hospital
Address
4-27-1, Kitaando, Aoi-ku, Shizuoka
Tel
054-247-6111
chiken-sougou@shizuoka-pho.jp
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
| 2015 | Year | 11 | Month | 01 | 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
2720
Results
A total of 1258 patients in the sterile group and 1376 patients in the non-sterile group were analyzed. The proportions of patients who were informed symptoms suggestive of urinary tract infection were 12 (1.0%) in the sterile group and 10 (0.73%) in the non-sterile group, respectively (p=0.52). There was no significant difference between the groups.
Results date posted
| 2022 | Year | 10 | Month | 03 | Day |
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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022500
| 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 |
