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Recruiting NCT07059858

NCT07059858 Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities

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Clinical Trial Summary
NCT ID NCT07059858
Status Recruiting
Phase
Sponsor Abant Izzet Baysal University
Condition Intellectual Disability
Study Type OBSERVATIONAL
Enrollment 100 participants
Start Date 2025-09-28
Primary Completion 2026-09-02

Eligibility & Interventions

Sex All sexes
Min Age 5 Years
Max Age 12 Years
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 100 participants in total. It began in 2025-09-28 with a primary completion date of 2026-09-02.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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

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

Contact & Investigator

Central Contact

Sezen Tezcan

✉ fztsezen@windowslive.com

📞 +905445723731

Principal Investigator

Sezen Tezcan, PhD

PRINCIPAL INVESTIGATOR

Abant Izzet Baysal University

Frequently Asked Questions

Who can join the NCT07059858 clinical trial?

This trial is open to participants of all sexes, aged 5 Years or older, up to 12 Years, studying Intellectual Disability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07059858 currently recruiting?

Yes, NCT07059858 is actively recruiting participants. Contact the research team at fztsezen@windowslive.com for enrollment information.

Where is the NCT07059858 trial being conducted?

This trial is being conducted at Bolu, Turkey (Türkiye).

Who is sponsoring the NCT07059858 clinical trial?

NCT07059858 is sponsored by Abant Izzet Baysal University. The principal investigator is Sezen Tezcan, PhD at Abant Izzet Baysal University. The trial plans to enroll 100 participants.

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