UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005713
Receipt number R000006550
Scientific Title Clinical survey for lower urinary tract symptoms and its treatment in female patients with life-style diseases visiting to general physicians
Date of disclosure of the study information 2011/07/01
Last modified on 2011/12/06 16:27:51

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Basic information

Public title

Clinical survey for lower urinary tract symptoms and its treatment in female patients with life-style diseases visiting to general physicians

Acronym

Survey for lower urinary tract dysfunction in female patients

Scientific Title

Clinical survey for lower urinary tract symptoms and its treatment in female patients with life-style diseases visiting to general physicians

Scientific Title:Acronym

Survey for lower urinary tract dysfunction in female patients

Region

Japan


Condition

Condition

Lower urinary tract symptoms

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify lower urinary tract symptoms and its treatment in female patients with life-style diseases visiting to general physicians

Basic objectives2

Others

Basic objectives -Others

Study with questionnaires

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lower Urinary tract symptoms

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Patients with life-style diseases
Patients who can write questionnaire by themselves
Patients with document of informed consent

Key exclusion criteria

Patients whom the doctors evaluate not appropriate for this study

Target sample size

7000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Yoshida

Organization

Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital

Division name

Medical Informatics

Zip code


Address

1670 Takehara-cho, Yatsusiro City, Kuammoto Japan

TEL

0965-33-4151

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kumamoto Rosai Hospital

Division name

Medical Informatics

Zip code


Address


TEL


Homepage URL


Email

uro-yoshida@kumamotoh.rofuku.go.jp


Sponsor or person

Institute

Study Group for Lower Urinary Tract Symptoms in Female

Institute

Department

Personal name



Funding Source

Organization

None

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

2011 Year 07 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

Enrolling by invitation

Date of protocol fixation

2010 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 03 Month 01 Day

Last follow-up date

2011 Year 08 Month 01 Day

Date of closure to data entry

2011 Year 12 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Evaluation of relationship between lower urinary tract symptoms and life-style diseases, and characteristics of lower urinary tract symptoms in female


Management information

Registered date

2011 Year 06 Month 03 Day

Last modified on

2011 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006550


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name