Cross-cultural adaptation and psychometric properties of the International Consultation on Incontinence Questionnaire Pediatric Lower Urinary Tract Symptoms (ICIQ-CLUTS): a Chinese validation study.

Abstract

Background: Lower urinary tract symptoms (LUTS) are common in pediatric patients and significantly affect children's well-being and family-related quality of life. However, no validated Chinese assessment tool for LUTS exists. This study aimed to develop and validate a Chinese version of the International Consultation on Incontinence Questionnaire-Pediatric Lower Urinary Tract Symptoms (ICIQ-CLUTS).

Methods: The ICIQ-CLUTS was translated following the Beaton cross-cultural adaptation guidelines. A total of 192 children with and without LUTS and their parents were enrolled between June and October 2024. Psychometric evaluation was performed using multiple approaches. Reliability was assessed using Cronbach's alpha coefficient for internal consistency. Validity was assessed by expert content review and exploratory factor analysis. Clinical diagnoses were made using standardized assessment protocols including medical history, physical examination, and laboratory tests (urinalysis and uroflowmetry) based on the International Children's Continence Society (ICCS) criteria. Using these clinical diagnoses as the reference standard, the diagnostic accuracy was evaluated using receiver operating characteristic (ROC) curve analysis.

Results: The study included 192 participants (70.8% male) divided into two age groups: 5-9 years (n = 139) and 10-14 years (n = 53). The Chinese ICIQ-CLUTS showed acceptable internal consistency (Cronbach's alpha = 0.718 for children's version; 0.706 for parents' version) and distinct factor structure. The diagnoses encompassed various LUTS manifestations including monosymptomatic nocturnal enuresis (MNE), non-monosymptomatic nocturnal enuresis (NMNE), and overactive bladder (OAB). Both versions exhibited high diagnostic accuracy (AUC = 0.948 for children's version; 0.933 for parents' version), with superior performance observed in the 10-14-year age group (AUC = 0.963 and 0.960, respectively). The optimal cut-off points were 13.5 for both versions, with sensitivity of 0.90 and specificity of 0.86 for the children's version, and sensitivity of 0.89 and specificity of 0.85 for the parents' version.

Conclusion: The Chinese version of ICIQ-CLUTS shows good psychometric properties and diagnostic accuracy, making it a useful screening tool for pediatric LUTS in Chinese-speaking populations.