UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049249 |
|---|---|
| Receipt number | R000056088 |
| Scientific Title | Investigation of the effectiveness of the NMOC-3WAY |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2022/10/18 12:08:20 |
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Basic information
Public title
Effects of new urinary catheters on discomfort
Acronym
Effects of new urinary catheters on discomfort
Scientific Title
Investigation of the effectiveness of the NMOC-3WAY
Scientific Title:Acronym
Investigation of the effectiveness of the NMOC-3WAY
Region
| Japan |
Condition
Condition
Male patients requiring a urinary catheter insertion
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Urinary catheters are commonly used in the operating room; however, patients may experience discomfort and pain. The NMOC-3WAY catheter, a urinary catheter with an injection slit, allows local anesthetic to be administered into the urethra and act on the urethral mucosa to provide surface anesthesia and reduce discomfort and pain during catheter placement. A study on this catheter was reported in 2018; however, no large prospective study on its effectiveness, particularly after returning to the room, has been conducted. This study aims to evaluate the effectiveness of this urinary catheter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether or not patients discomfort with the urinary catheter after awakening from anesthesia improved with the administration of a therapeutic drug.
Key secondary outcomes
Whether or not the therapeutic drug is needed again within 24 h
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Male surgical patients undergoing general anesthesia, requiring Foley catheter insertion, and consenting to participate in the study
Key exclusion criteria
1 < 18 years old
2 ASA3 or higher
3 Patients presenting difficulty in evaluating each measurement
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kameyama |
Organization
Sendai City Hospital
Division name
Anesthesiology
Zip code
982-8502
Address
1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi
TEL
+81223087111
y.kame1116@mac.com
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kameyama |
Organization
Sendai City Hospital
Division name
Anesthesiology
Zip code
982-8502
Address
1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi
TEL
+81223087111
Homepage URL
y.kame1116@mac.com
Sponsor or person
Institute
Sendai City Hospital, department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Sendai City Hospital, department of anesthesiology
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
Sendai City Hospital
Address
1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi
Tel
+81223087111
y.kame1116@mac.com
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
| 2022 | Year | 10 | Month | 19 | 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
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
On a 5-point scale, 0 will indicate none, 1 will represent a little discomfort/urination/pain, 2 discomfort/urination/pain, 3 considerable discomfort/urination/pain, and 4 unbearable discomfort/urination/pain.
Management information
Registered date
| 2022 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056088
| 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 |
