Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities

Официальное название

Evaluation of Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities

Обзор

Many neurodevelopmental, psychiatric, and medical disorders are commonly associated with intellectual disability. The presence of neurodevelopmental and psychiatric (NDP) comorbidities has been reported to negatively impact the clinical outcomes of bowel or bladder dysfunction. Pediatric bladder and bowel dysfunction (BBD) is a common but underdiagnosed condition characterized by a spectrum of lower urinary tract symptoms and is often associated with constipation. Lower urinary tract symptoms include dysuria, urinary urgency, daytime incontinence, and enuresis, while bowel symptoms include constipation and encopresis. Most BBD cases are functional and not neurogenic in origin. In children with special needs, all types of urinary incontinence are reported to occur more frequently compared to children without developmental or behavioral disabilities. Intellectual disability (IQ \<70) is also identified as a significant risk factor for urinary incontinence, with prevalence increasing as IQ decreases. In these children, lower urinary tract symptoms such as overactive bladder, dysfunctional voiding, and low fluid intake are also observed. Furthermore, according to support plans and medical records, 94% of individuals with intellectual and multiple disabilities experience constipation. Interestingly, lower levels of intellectual disability (profound and severe ID) have been associated with a lower prevalence of constipation. Although there are studies in the literature examining bladder and bowel functions separately in specific diagnostic groups with intellectual disability, the number of studies that assess bladder and bowel functions together in children with any form of intellectual disability is limited. Moreover, to our knowledge, there is no study in the literature that evaluates bladder and bowel functions along with child participation and parental quality of life in children with intellectual disability. Based on this gap in the literature, the aim of our study is to examine bladder and bowel functions, participation, and quality of life in children with intellectual disability

Подробное описание

This cross-sectional study will include children aged 5-12 years with intellectual disabilities who are attending Special Education and Rehabilitation Centers, as well as typically developing children. Necessary approvals will be obtained from the Non-Interventional Clinical Research Ethics Committee of Bolu Abant Izzet Baysal University.

Participants will be selected according to predefined inclusion criteria. Informed consent will be obtained from both the children included in the study and their parents. Sociodemographic data such as parents' age, height, weight, marital status, and education level will be recorded. Similarly, data on the children, including age, height, weight, and gender, will be collected.

Bladder and bowel functions of the children included in the study will be assessed using the Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ), the Dysfunctional Voiding and Incontinence Scoring System (DVISS), and the Lower Urinary Tract Symptom Score (LUTSS). Child participation will be evaluated using the Child and Adolescent Scale of Participation (CASP). Parental quality of life will be assessed using the Nottingham Health Profile (NHP), and children's quality of life will be evaluated using the Pediatric Quality of Life Inventory - Gastrointestinal Symptoms Module (PedsQL GI Module)

Первичные конечные точки

• Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ [Срок оценки: baseline]
• Bladder and Bowel Dysfunction Scale (BBDS) [Срок оценки: baseline]
• Voiding Dysfunction Symptom Score (VDSS) [Срок оценки: baseline]
• Child and Adolescent Scale of Participation (CASP) [Срок оценки: baseline]

Вторичные конечные точки (2)

• Pediatric Quality of Life Inventory - Gastrointestinal Symptoms Module (PedsQL GI Module) [Срок оценки: baseline]
• Nottingham Health Profile (NHP) [Срок оценки: baseline]

Критерии участия

Критерии включения

For Children with Intellectual Disabilities:

• Aged between 5 and 12 years
• Diagnosed with mild, moderate, or severe intellectual disability as documented by the ÇÖZGER (Child Special Needs Report)
• Both the parent and the child agree to participate in the study

For Typically Developing Children

• Aged between 5 and 12 years
• Both the parent and the child agree to participate in the study

Критерии исключения

For Children with Intellectual Disabilities:

• Having a diagnosis of physical disability
• Presence of a neurological anomaly affecting bladder and bowel functions
• Parent does not consent to participate in the study
• Having undergone trauma or surgery affecting bladder and bowel functions within the last 6 months
• Diagnosis of a genetic disorder
• Use of medications that may affect bladder and bowel functions

For Typically Developing Children

• Presence of a neurological anomaly affecting bladder and bowel functions
• Lack of parental consent to participate in the study
• Having experienced trauma or undergone surgery affecting bladder and bowel functions within the past 6 months
• Use of medications that may influence bladder and bowel functions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Abant Izzet Baysal University Faculty of Health Science — Bolu

Идентификаторы

NCT: NCT07059858 · AIBU-FTR-ST-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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