UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060884 |
|---|---|
| Receipt number | R000069671 |
| Scientific Title | Health Economic Study of cutaneous vesicostomy |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/03/10 11:02:32 |
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Basic information
Public title
Health Economic Study of cutaneous vesicostomy
Acronym
Health Economic Study of cutaneous vesicostomy
Scientific Title
Health Economic Study of cutaneous vesicostomy
Scientific Title:Acronym
Health Economic Study of cutaneous vesicostomy
Region
| Japan |
Condition
Condition
UTI
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the medical and economic usefulness of a bladder cutaneous fistula
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medical expenses for five years after cutaneous vesicostomy performed
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
| 59 | years-old | <= |
Age-upper limit
| 93 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A case in which a cutaneous vesicostomy was created at our hospital
Key exclusion criteria
No exclusion criteria
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Itsuki |
| Middle name | |
| Last name | Mukaigaito |
Organization
Yamanashi kohsei hospital
Division name
Urology
Zip code
4228027
Address
1-4-56-101 Toyoda Suruga-ku Shizuokashi Shizuokaken
TEL
08014831034
itsukim.yamanashi0651@outlook.jp
Public contact
Name of contact person
| 1st name | Itsuki |
| Middle name | |
| Last name | Mukaigaito |
Organization
Yamanashi kohsei hospital
Division name
urology
Zip code
4228027
Address
1-4-56-101 Toyoda Suruga-ku Shizuokashi Shizuokaken
TEL
08014831034
Homepage URL
itsukim.yamanashi0651@outlook.jp
Sponsor or person
Institute
Yamanashi kohsei hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Yamanashi kohsei hospital
Address
860 otiai yamanasisi yamanashikenn
Tel
0553231311
itsukim.yamanashi0651@outlook.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
| 2026 | Year | 05 | 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
11
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compared the medical costs after the cutaneous vesicostomy with the estimated medical costs if it was not created.
Management information
Registered date
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069671
