Intellectual DisabilityNCT07059858
Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities
An observational study of Intellectual Disability and Healthy Subjects, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Intellectual Disability, Healthy Subjects
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2025to 2 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Child
Study population: Children diagnosed with intellectual disability and typically developing peers who agreed to participate in the study and met the inclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University Faculty of Health Science
Bolu, 14100
About this study
Official title: Evaluation of Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities
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.
Read more
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
Read the 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
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intellectual Disability Group | Individuals between the ages of 5-12 years with a diagnosis of intellectual disability | |
| Typical Developing Group | Typically developing individuals between the ages of 5-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ
The CBBDQ is a parent-reported instrument used to assess and quantitatively measure symptoms of bladder and bowel dysfunction in children. It is designed for children aged 5 to 12 years and consists of 18 items, including 10 items related to bladder symptoms and 8 items related to bowel symptoms. Each item is rated on a five-point Likert scale ranging from 0 (never) to 4 (almost every day or every day). Higher CBBDQ scores indicate the presence of more severe or frequent symptoms.
Measured: baseline
Bladder and Bowel Dysfunction Scale (BBDS)
The BBDS is a 14-item questionnaire designed to assess pediatric bladder and bowel dysfunction. Each item is rated using a five-point Likert scale. The total score ranges from 0 to 52, with higher scores indicating greater symptom severity. The scale includes 14 questions, of which the first 13 specifically address symptoms related to bladder and bowel dysfunction. The final question evaluates the level of difficulty experienced while completing the questionnaire and is not included in the total score.
Measured: baseline
Voiding Dysfunction Symptom Score (VDSS)
The Voiding Dysfunction Symptom Score (VDSS) was developed by Akbal et al. in 2005 and consists of 14 items. Thirteen of the items assess symptoms related to daytime urinary incontinence, nighttime urinary incontinence (enuresis), urinary frequency during the day, the presence of constipation, and various lower urinary tract symptoms. The 14th item evaluates the impact of these symptoms on quality of life.
The total score ranges from 0 to 35 points, with higher scores indicating increased severity of voiding dysfunction symptoms. The overall score is considered to be 35+3, with the additional 3 points referring to the quality-of-life impact assessment.
Measured: baseline
Child and Adolescent Scale of Participation (CASP)
The Child and Adolescent Scale of Participation (CASP) is a caregiver-reported measure used to assess the extent to which school-aged children (aged 5 years and older) participate in home, school, and community activities compared to their same-age peers. The scale consists of 20 items grouped into four subdomains: Home Participation (6 items), Community Participation (4 items), School Participation (5 items), and Home and Community Living Activities (5 items).
Each of the 20 items is rated on a four-point scale: "Age Expected (Full participation)," "Somewhat Limited," "Very Limited," and "Unable to Participate." If the item reflects an activity that is not age-appropriate for the child (e.g., employment), the response "Not Applicable" is selected. Higher scores indicate greater levels of participation.
In addition, the CASP includes five open-ended questions that explore effective strategies and supports, as well as barriers that may influence the child's participation.
Measured: baseline
Secondary outcomes (2)
Pediatric Quality of Life Inventory - Gastrointestinal Symptoms Module (PedsQL GI Module)
The PedsQL GI Module is designed for different age groups (2-4 years, 5-7 years, 8-12 years, and 13-18 years). It includes 74 items for both child self-report and parent proxy-report versions. The module consists of 10 separate Likert-type subscales that assess various gastrointestinal symptoms. Higher scores on the PedsQL GI Module indicate better health-related quality of life, while lower scores reflect a greater negative impact of gastrointestinal symptoms on quality of life.
Measured: baseline
Nottingham Health Profile (NHP)
The Nottingham Health Profile (NHP) is used to assess health-related quality of life. It is a general quality of life questionnaire that measures an individual's perceived health problems and the extent to which these problems affect normal daily activities. The questionnaire consists of 38 items and evaluates six dimensions of health status. The items are answered with a "yes" or "no" response. Each section is scored on a scale from 0 to 100, where a score of 0 indicates the best possible health status and a score of 100 indicates the worst. Within the scope of this study, both the subscale scores and the total NHP score will be evaluated. The total NHP score will be calculated as the sum of the subscale scores.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start28 Sep 2025
- Primary completion2 Mar 2026
- Study completion2 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sezen Tezcan, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059858
- Sponsor's protocol ID
- AIBU-FTR-ST-06
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT07059858
- Acronym / sponsor ID
- AIBU-FTR-ST-06
- Conditions
- Intellectual Disability, Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intellectual Disability Group | – | –Individuals between the ages of 5-12 years with a diagnosis of intellectual disability |
| Typical Developing Group | – | –Typically developing individuals between the ages of 5-12 |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Children diagnosed with intellectual disability and typically developing peers who agreed to participate in the study and met the inclusion criteria.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ
Time frame: baseline
The CBBDQ is a parent-reported instrument used to assess and quantitatively measure symptoms of bladder and bowel dysfunction in children. It is designed for children aged 5 to 12 years and consists of 18 items, including 10 items related to bladder symptoms and 8 items related to bowel symptoms. Each item is rated on a five-point Likert scale ranging from 0 (never) to 4 (almost every day or every day). Higher CBBDQ scores indicate the presence of more severe or frequent symptoms.
Bladder and Bowel Dysfunction Scale (BBDS)
Time frame: baseline
The BBDS is a 14-item questionnaire designed to assess pediatric bladder and bowel dysfunction. Each item is rated using a five-point Likert scale. The total score ranges from 0 to 52, with higher scores indicating greater symptom severity. The scale includes 14 questions, of which the first 13 specifically address symptoms related to bladder and bowel dysfunction. The final question evaluates the level of difficulty experienced while completing the questionnaire and is not included in the total score.
Voiding Dysfunction Symptom Score (VDSS)
Time frame: baseline
The Voiding Dysfunction Symptom Score (VDSS) was developed by Akbal et al. in 2005 and consists of 14 items. Thirteen of the items assess symptoms related to daytime urinary incontinence, nighttime urinary incontinence (enuresis), urinary frequency during the day, the presence of constipation, and various lower urinary tract symptoms. The 14th item evaluates the impact of these symptoms on quality of life. The total score ranges from 0 to 35 points, with higher scores indicating increased severity of voiding dysfunction symptoms. The overall score is considered to be 35+3, with the additional 3 points referring to the quality-of-life impact assessment.
Child and Adolescent Scale of Participation (CASP)
Time frame: baseline
The Child and Adolescent Scale of Participation (CASP) is a caregiver-reported measure used to assess the extent to which school-aged children (aged 5 years and older) participate in home, school, and community activities compared to their same-age peers. The scale consists of 20 items grouped into four subdomains: Home Participation (6 items), Community Participation (4 items), School Participation (5 items), and Home and Community Living Activities (5 items). Each of the 20 items is rated on a four-point scale: "Age Expected (Full participation)," "Somewhat Limited," "Very Limited," and "Unable to Participate." If the item reflects an activity that is not age-appropriate for the child (e.g., employment), the response "Not Applicable" is selected. Higher scores indicate greater levels of participation. In addition, the CASP includes five open-ended questions that explore effective strategies and supports, as well as barriers that may influence the child's participation.
2 secondary outcomes
Pediatric Quality of Life Inventory - Gastrointestinal Symptoms Module (PedsQL GI Module)
Time frame: baseline
Nottingham Health Profile (NHP)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sezen Tezcan, PhD principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability and Healthy Subjects, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.