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

NCT ID: NCT07059858

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-28
• Study Completion Date: 2026-12-02

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)

Conditions

Intellectual Disability; Healthy Subjects

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Intellectual Disability Group

Individuals between the ages of 5-12 years with a diagnosis of intellectual disability

No interventions assigned to this group

Typical Developing Group

Typically developing individuals between the ages of 5-12

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sezen Tezcan, PhD

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

Abant Izzet Baysal University Faculty of Health Science

Bolu, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Sezen Tezcan

Role: CONTACT

fztsezen@windowslive.com

+905445723731

Facility Contacts

Ramazan Kurul, Ph.D

Role: primary

ramazankurul2@hotmail.com

+905436414731

Enes Tayyip Benli, MSc

Role: backup

enestayyipbenli@gmail.com

+905387359268

Other Identifiers

AIBU-FTR-ST-06

Identifier Type: -

Identifier Source: org_study_id