UMIN-CTR Clinical Trial

Basic information
Public title	A observational study of the impact of metabolic syndrome on lower urinary tract symptoms in community-dwelling population
Acronym	A observational study of the impact of metabolic syndrome on lower urinary tract symptoms in community-dwelling population
Scientific Title	A observational study of the impact of metabolic syndrome on lower urinary tract symptoms in community-dwelling population
Scientific Title:Acronym	A observational study of the impact of metabolic syndrome on lower urinary tract symptoms in community-dwelling population
Region	Japan

Condition
Condition	lower urinary tract symptoms
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the impact of metabolic syndrome (Mets) on lower urinary tract symptoms in community-dwelling population.
Basic objectives2	Others
Basic objectives -Others	Relationship
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between metabolic syndrome and lower urinary tract symptoms (LUTS) using International Prostate Symptom Score (IPSS).
Key secondary outcomes	IPSS sub-score and f metabolic syndrome Overactive Bladder Symptom Score (OABSS) sub-score and metabolic syndrome Relationship between metabolic syndrome and oxidative stress Relationship between metabolic syndrome and frailty

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who participant in the Iwaki health promotion project after 2006
Key exclusion criteria	Subjects who could not evaluate lower urinary tract symptoms.
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Urology
Zip code	036-8562
Address	5 Zaifu-chou
TEL	0172395091
Email	shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Urology
Zip code	036-8562
Address	5 Zaifu-chou
TEL	0172395091
Homepage URL
Email	shingoh@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hirosaki University School of Medicine IRB
Address	Hirosaki
Tel	0172395091
Email	rinri@hirosaki-u.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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 09 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/30216623/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/30216623/
Number of participants that the trial has enrolled	1113
Results	We observed a significant association between AGE levels and nocturia score > 1. Further research is necessary to clarify a possible causal relationship between oxidative stress and nocturia.
Results date posted	2022 Year 12 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	To investigate the relationship between oxidative stress and lower urinary tract symptoms (LUTS) in a community-dwelling population.
Participant flow	he cross-sectional study included 1 113 people who participated in the Iwaki Health Promotion Project of 2015 in Hirosaki, Japan. LUTS were assessed using structured questionnaires, including the International Prostate Symptom Score (IPSS) and the Overactive Bladder Symptom Score (OABSS). IPSS > 7, OABSS > 5, nocturia score > 1, or urge incontinence score > 1 were defined as moderate to severe symptoms. 8-Hydroxy-2'-deoxyguanosine (8-OHdG) and advanced glycation end products (AGEs) were measured by urine analysis and skin autofluorescence, respectively.
Adverse events	none
Outcome measures	The relationship between oxidative stress and LUTS was investigated using logistic regression analyses.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 07 Day
Date of IRB	2021 Year 04 Month 30 Day
Anticipated trial start date	2017 Year 07 Month 08 Day
Last follow-up date	2022 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study is retrospective/prospective study of the impact of metabolic syndrome on lower urinary tract symptoms in community-dwelling population. Patients in this study undergo metabolic syndrome assessment including waist circumference, hypertension, hyperglycemia, dyslipidemia and basic frailty assessment, and oxidative stress. Relationship between lower urinary tract symptoms, metabolic syndrome, frailty and oxidative stress are evaluated.

Management information
Registered date	2017 Year 08 Month 05 Day
Last modified on	2022 Year 12 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032675