UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036097 |
|---|---|
| Receipt number | R000041122 |
| Scientific Title | "Investigation of the relationship between the recurrence of non-muscle invasive bladder cancer (NMIBC) and intake of the therapeutic agent for dysuria." |
| Date of disclosure of the study information | 2019/03/07 |
| Last modified on | 2025/03/11 08:35:19 |
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Basic information
Public title
"Investigation of the relationship between the recurrence of non-muscle invasive bladder cancer (NMIBC) and intake of the therapeutic agent for dysuria."
Acronym
"Investigation of the relationship between the recurrence of non-muscle invasive bladder cancer (NMIBC) and intake of the therapeutic agent for dysuria."
Scientific Title
"Investigation of the relationship between the recurrence of non-muscle invasive bladder cancer (NMIBC) and intake of the therapeutic agent for dysuria."
Scientific Title:Acronym
"Investigation of the relationship between the recurrence of non-muscle invasive bladder cancer (NMIBC) and intake of the therapeutic agent for dysuria."
Region
| Japan |
Condition
Condition
The non-muscle invasive bladder cancer (NMIBC)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the relationship between the episode of treatment of therapeutic agents for dysuria and recurrence of NMIBC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EORTC recurrence score and CUETO recurrence score are calculated of each patient, 2nd TUR-BT and BCG therapy, kinds of current or past of medication history of therapeutic agent for dysuria and recurrence status are recorded.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were NMIBC (<=T1) and urothelial carcinoma.
Key exclusion criteria
The exclusion criteria were the case have past history of primary upper urinary cancer or were the cases with a follow-up period of less than 6 months.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Obara |
Organization
Iwate Medical University
Division name
Urology
Zip code
020-8505
Address
19-1 Uchimaru, Morioka-shi, Iwate, Japan
TEL
+81196515111
watao@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Kato |
Organization
Iwate Medical University
Division name
Urology
Zip code
020-8505
Address
19-1 Uchimaru, Morioka-shi, Iwate, Japan
TEL
+81196515111
Homepage URL
katoyooo@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
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
Iwate Medical University
Address
19-1 Uchimaru, Morioka-shi, Iwate, Japan
Tel
+81196515111
kenta.abe@j.iwate-med.ac.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
| 2019 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC8381433/pdf/10.1177_03000605211037478.pdf
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC8381433/pdf/10.1177_03000605211037478.pdf
Number of participants that the trial has enrolled
162
Results
A total of 162 patients were included, with 84 patients in the non-recurrence group and 78 patients in the recurrence group. In the multivariate analysis, the intake of dysuria agents and bacillus Calmette-Guerin (BCG) therapy were independent factors. The RFS results in terms of the intake of dysuria agents were statistically significant before and after PSM analysis, but no factors were significantly different between the BCG and non-BCG groups after PSM.
Results date posted
| 2025 | Year | 03 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Non-muscle invasive bladder cancer patients
Participant flow
Medical records
Adverse events
None
Outcome measures
Recurrence free survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Opted out.
Management information
Registered date
| 2019 | Year | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041122
