UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevalence of stress incontinence or over active bladder in patients with pollinosis
Title of the study (Brief title)	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	Motofumi Suzuki
Organization	The University of Tokyo Hospital
Division name	Department of Urology
Address	7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL	03-5800-8753
Email

Public contact
Name of contact person	Motofumi Suzuki
Organization	The University of Tokyo Hospital
Division name	Department of Urology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 04 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006216