UMIN-CTR Clinical Trial

Basic information
Public title	Examination of disinfection method for urine after BCG intravesical infusion therapy
Acronym	Examination of disinfection method for urine after BCG intravesical infusion therapy
Scientific Title	Examination of disinfection method for urine after BCG intravesical infusion therapy
Scientific Title:Acronym	Examination of disinfection method for urine after BCG intravesical infusion therapy
Region	Japan

Condition
Condition	Bladder cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Disinfect BCG-containing urine with Etaprocol, and examine whether it is more effective and safer than disinfection with sodium hypochlorite.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the temperature rise that occurs when each disinfectant solution is added to BCG-containing urine and mixed together
Key secondary outcomes	Evaluation of the concentration of gas generated when each disinfectant solution is added and mixed with BCG-containing urine, the disinfecting effect of each disinfectant on Mycobacterium tuberculosis, and the sensory degree of the odor generated at that time.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Disinfect BCG-containing urine with Etaprocol, and examine whether it is more effective and safer than disinfection with sodium hypochlorite.
Interventions/Control_2	Disinfect BCG-containing urine with Etaprocol, and examine whether it is more effective and safer than disinfection with sodium hypochlorite.
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	Patients diagnosed with non-muscle invasive bladder cancer and required BCG intravesical instillation therapy
Key exclusion criteria	Patients who are contraindicated for BCG intravesical instillation therapy
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Kameda
Organization	Haga red cross hospital
Division name	Urology
Zip code	321-4308
Address	271 Nakago, Moka, Tochigi
TEL	0285-82-2195
Email	kamedadesu1002@yahoo.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Kameda
Organization	Haga red cross hospital
Division name	Urology
Zip code	321-4308
Address	271 Nakago, Moka, Tochigi
TEL	0285-82-2195
Homepage URL
Email	kamedadesu1002@yahoo.co.jp

Sponsor
Institute	Haga red cross hospital
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Sapporo Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Haga red cross hospital
Address	271 Nakago, Moka, Tochigi 321-4308
Tel	0285-82-2195
Email	kamedadesu1002@yahoo.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	R3_15
Org. issuing International ID_1	Haga Red Cross Hospital Ethics Review Committee
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 01 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
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	No longer recruiting
Date of protocol fixation	2021 Year 11 Month 16 Day
Date of IRB	2022 Year 01 Month 01 Day
Anticipated trial start date	2021 Year 12 Month 15 Day
Last follow-up date	2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 12 Month 09 Day
Last modified on	2022 Year 11 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052873