UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005560 |
|---|---|
| Receipt number | 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 13:10:38 |
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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
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
suzukim-uro@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006216
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
