UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028548 |
|---|---|
| Receipt number | R000032675 |
| Scientific Title | A observational study of the impact of metabolic syndrome on lower urinary tract symptoms in community-dwelling population |
| Date of disclosure of the study information | 2017/08/09 |
| Last modified on | 2022/12/06 12:48:13 |
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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
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
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032675
