Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT07059858
Brief Summary:
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
Detailed Description:
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)
Study:
NCT07059858
Study Brief:
Protocol Section:
NCT07059858