Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060001) titled 'Study on the Relationship Between Oral Hypofunction and Overactive Bladder' on Dec. 31.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Yamagata University

Condition: Condition - Oral Dysfunction Syndrome and Overactive Bladder Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - At the initial visit, participants will undergo a one-time clinical assessment for oral hypofunction and complete a urinary symptom questionnaire.

Eligibility: Age-lower limit - 40 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 Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 01 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068623

Disclaimer: Curated by HT Syndication.