UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021854
Receipt number 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 10:20:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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

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 or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



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

Value
https://center6.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