UMIN-CTR Clinical Trial

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

Condition
Condition	Lower urinary tract symptoms (LUTS)
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the impact of frailty 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 frailty and lower urinary tract symptoms (LUTS) using International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS) and frailty assessment tools such as G8 and/or Frailty Discriminant score
Key secondary outcomes	IPSS sub-score and frailty OABSS sub-score and frailty Relationship between frailty and oxidative stress, and LUTS

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	4000

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

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

IRB Contact (For public release)
Organization	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/31642610/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/31642610/
Number of participants that the trial has enrolled	710
Results	Individuals with LUTS are potentially frailer than those without LUTS. Although the influence of frailty on LUTS is different depending on the measurement tool, attention for frailty is necessary for subjects with LUTS.
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 evaluate the relationship between frailty and lower urinary tract symptoms (LUTS), the association of frailty and LUTS remains unclear.
Participant flow	This cross-sectional study investigated LUTS and frailty in 710 individuals (249 men and 461 women) who participated in the Iwaki Health Promotion Project between 2014 and 2015 in Hirosaki, Japan. Parameters of frailty were compared for individuals with mild and moderate to severe symptoms of LUTS. The International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS) were used to evaluate LUTS. Frailty was evaluated by the frailty phenotype (FP), modified frailty index (mFI), and frailty discriminant score (FDS).
Adverse events	none
Outcome measures	The influence of frailty on LUTS was investigated by multivariate logistic regression analyses.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 07 Month 02 Day
Anticipated trial start date	2017 Year 07 Month 02 Day
Last follow-up date	2022 Year 11 Month 30 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 frailty on lower urinary tract symptoms in community-dwelling population. Patients in this study undergo frailty assessment including gait speed, handgrip strength, fatigue and depression questionnaire, and basic blood biochemical test. Frailty Discriminant score were calculated, and outcomes 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=R000032672