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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021854
Receipt No. R000025199
Scientific Title Study the role of water channels in human bladder epithelium involved in water re-absorption function
Date of disclosure of the study information 2016/04/10
Last modified on 2017/10/11

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Basic information
Public title Study the role of water channels in human bladder epithelium involved in water re-absorption function
Acronym Study the role of water channels in human bladder epithelium
Scientific Title Study the role of water channels in human bladder epithelium involved in water re-absorption function
Scientific Title:Acronym Study the role of water channels in human bladder epithelium
Region
Japan

Condition
Condition overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 It is pointed out that human bladder may be involved in resorption of moisture in the bladder, but its detailed mechanism is unknown.

As a candidate for water channel responsible for water reabsorption in the human bladder, aquaporin (water channel present in cell membrane, water enters and exits intracellularly and extracellularly) and gap junction (water channel of intercellular junction, water Confirmed its existence and structure at the histological and electron microscopic level and confirmed the possibility that human bladder is involved in reabsorption of intravesical water retention moisture .
In addition, sodium ion channel, chloride ion channel and water channel function in human bladder are verified by short-circuit current measurement and functionally confirm water reabsorption in human bladder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes At our hospital we perform total bladder cystectomy for bladder cancer, and from the specimen we pick up, we can gather parts that are considered macroscopically normal tissue. In the collected tissues, the presence and the structure of aquaporin 3 and aquaporin 1, whose presence is predicted in human bladder tissue, existence and structure are confirmed at the collaborative research institution at the histological and electron microscopic level . Especially, normal bladder tissues immediately after removal are loaded into the Ussing chamber and the functions and control mechanisms of the sodium ion channel / chloride ion channel / water channel are clarified. Furthermore, in order to confirm whether the tissue used in this study is a normal tissue, some specimens for tissue diagnosis are also stored at the time of tissue collection.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 At our hospital we perform total bladder cystectomy for bladder cancer, and from the specimen we pick up, we can gather parts that are considered macroscopically normal tissue. In the collected tissues, the presence and the structure of aquaporin 3 and aquaporin 1, whose presence is predicted in human bladder tissue, existence and structure are confirmed at the collaborative research institution at the histological and electron microscopic level . Especially, normal bladder tissues immediately after removal are loaded into the Ussing chamber and the functions and control mechanisms of the sodium ion channel / chloride ion channel / water channel are clarified. Furthermore, in order to confirm whether the tissue used in this study is a normal tissue, some specimens for tissue diagnosis are also stored at the time of tissue collection.
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 Patients who underwent cystectomy against bladder cancer in our hospital
Key exclusion criteria Not applicable
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Ukimura Osamu
Organization Kyoto Prefectural University of Medicine
Division name Urology
Zip code
Address 465 kaji-cho,Kamigyo-ku Kyoto,Japan,602-8566
TEL 075-251-5595
Email ukimura@koto.kpu-m.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takeshi Nomura
Organization Kyoto Prefectural University of Medicine
Division name Urology
Zip code
Address 465 kaji-cho,Kamigyo-ku Kyoto,Japan,602-8566
TEL 075-251-5595
Homepage URL
Email takeshi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
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
Address
Tel
Email

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
2016 Year 04 Month 10 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 10 Day
Last modified on
2017 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025199

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/06/02 print_decide.pdf


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