UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060001 |
|---|---|
| Receipt number | R000068623 |
| Scientific Title | A Prospective Observational Study on the Association Between Oral Hypofunction and Overactive Bladder in Dental Examinations |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/12/07 01:04:03 |
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Basic information
Public title
Study on the Relationship Between Oral Hypofunction and Overactive Bladder
Acronym
Oral Function and OAB Study
Scientific Title
A Prospective Observational Study on the Association Between Oral Hypofunction and Overactive Bladder in Dental Examinations
Scientific Title:Acronym
OFD OAB Study
Region
| Japan |
Condition
Condition
Oral Dysfunction Syndrome and Overactive Bladder
Classification by specialty
| Urology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the association between objectively assessed oral hypofunction during dental examinations and overactive bladder (OAB). Recent studies have reported that impaired oral function may influence systemic inflammation and autonomic nervous activity, suggesting a potential role in the development or exacerbation of OAB. In this study, we will evaluate oral function tests and urinary symptom questionnaires administered to patients visiting dental and urology clinics, and investigate the relationship between these factors.
Basic objectives2
Others
Basic objectives -Others
Investigation of the association between the two diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The association between the presence of overactive bladder and oral hypofunction
Key secondary outcomes
The association between OABSS scores and the presence of oral hypofunction
The association between the presence of OAB and individual components of oral hypofunction
The association between OABSS sub-scores and the presence of oral hypofunction
The association between the presence of OAB and salivary metabolites
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
At the initial visit, participants will undergo a one-time clinical assessment for oral hypofunction and complete a urinary symptom questionnaire.
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 40 years or older who attend the Department of Oral and Maxillofacial Surgery or the Department of Urology at Yamagata University Hospital.
Individuals who receive a written explanation of the purpose and procedures of the study and provide voluntary written informed consent.
Individuals who are able to undergo oral function assessments and evaluations using urinary symptom scores.
Individuals who are able to provide a saliva sample (approximately 2 or 3 mL collected by the passive drool method).
Key exclusion criteria
Individuals who have difficulty completing the questionnaires due to cognitive impairment or other reasons.
Individuals with severe systemic illness (such as acute inflammation or advanced cancer) for whom participation in the study is deemed inappropriate by the attending physician.
Individuals who have already received pharmacological or surgical treatment for benign prostatic hyperplasia (BPH) or overactive bladder (OAB).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Ito |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Urology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata-shi, Yamagata
TEL
0236285368
sugu1219@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Ito |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Urology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata-shi, Yamagata
TEL
0236285368
Homepage URL
sugu1219@yahoo.co.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Suguru Ito
Funding Source
Organization
Yamagata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-Nishi, Yamagata-shi, Yamagata
Tel
08016705845
sugu1219@yahoo.co.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
Yamagata
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 07 | Day |
Last modified on
| 2025 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068623
