UMIN-CTR Clinical Trial

Basic information
Public title	The exploration of urinary biomarkers in patients with lower urinary tract dysfunction
Acronym	Urinary biomarkers of lower urinary tract dysfunction
Scientific Title	The exploration of urinary biomarkers in patients with lower urinary tract dysfunction
Scientific Title:Acronym	Urinary biomarkers of lower urinary tract dysfunction
Region	Japan

Condition
Condition	Lower urinary tract dysfunction
Classification by specialty	Urology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify novel urinary biomarkers in patients with lower urinary tract dysfunction.
Basic objectives2	Others
Basic objectives -Others	Desease-specific biomarkers in urine
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To identify novel urinary biomarkers in patients with lower urinary tract dysfunction (benign prostatic hyperplasia, overactive bladder, interstitial cystitis, underactive bladder).
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	1. Patients with lower urinary tract dysfunction (benign prostatic hyperplasia, overactive bladder, interstitial cystitis, low activity bladder). 2. Normal volunteers who have no lower urinary tract symptoms.
Key exclusion criteria	Person who is considered ineligible by an attending physician.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Otsuka Middle name Last name Atsushi
Organization	Hamamatsu University School of Medicine
Division name	Urology
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2306
Email	otsuka@hama-med.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Otsuka
Organization	Hamamatsu University School of Medicine
Division name	Urology
Zip code	431-4392
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2306
Homepage URL
Email	otsuka@hama-med.ac.jp

Sponsor
Institute	Department of Urology, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Self-funding
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	Institutional Review Board of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel	053-435-2111
Email	rinri@hama-med.ac.jp

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	浜松医科大学病院（静岡県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 14 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	Open public recruiting
Date of protocol fixation	2017 Year 10 Month 13 Day
Date of IRB	2017 Year 11 Month 07 Day
Anticipated trial start date	2017 Year 11 Month 14 Day
Last follow-up date	2027 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Profiles of urine biomarkers are compared between 200 patients with lower urinary tract dysfunction and approximately 50 healthy controls.

Management information
Registered date	2017 Year 11 Month 14 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033764