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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005560
Receipt No. R000006216
Scientific Title Prevalence of stress incontinence or over active bladder in patients with pollinosis
Date of disclosure of the study information 2011/05/06
Last modified on 2019/02/08

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Basic information
Public title Prevalence of stress incontinence or over active bladder in patients with pollinosis
Acronym Pollinosis and urinary incontinence
Scientific Title Prevalence of stress incontinence or over active bladder in patients with pollinosis
Scientific Title:Acronym Pollinosis and urinary incontinence
Region
Japan

Condition
Condition Pollinosis
Classification by specialty
Clinical immunology Oto-rhino-laryngology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is surveying the prevalence of lower urinary tract symptoms including urinary incontinence and urgency among patients with pollinosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Core Lower urinary tract Symptom Score
International Prostate Symptom Score
Overactive Bladder Symptom Score
JRQLQ
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pollinosis
Key exclusion criteria 1 Patients with pollinosis who have already treated.
2 Patients with pollinosis who cannot receive standard treatment because of any reason
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motofumi Suzuki
Organization The University of Tokyo Hospital
Division name Department of Urology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-8753
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motofumi Suzuki
Organization The University of Tokyo Hospital
Division name Department of Urology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-8753
Homepage URL
Email suzukim-uro@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization The University of Tokyo Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Seirei Hamamatsu Genaral Hospital
Hamamatsu University School of Medicine
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 聖隷浜松病院(静岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 06 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 Terminated
Date of protocol fixation
2011 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information 1) Primary end point
Urination related questionnairs
Core Lower urinary tract Symptom Score; CLSS
International Prostate Symptom Score; IPSS
Overactive Bladder Symptom Score; OABSS
2)Secondary end point
JRQLQ

Management information
Registered date
2011 Year 05 Month 06 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006216

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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