Urinary IncontinenceNCT02368262
Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
An observational study of Urinary Incontinence, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study evaluates (risk)factors influencing (in)continence in children with and without a brain injury. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Questionnaire and micturition and drinking diaries and Uroflowmetry, pelvic floor EMG and bladderscan
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Dec 2016
- 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
- Healthy volunteers accepted
- Child
Study population: Children with CP: Cerebral palsy Reference Centre (Ghent university hospital) Incontinent children with normal development: Urology department (Ghent university hospital) continent children with normal development: community sample
Who may be able to join
- Daytime urinary incontinence with or without enuresis and/or fecal incontinence (Groups with incontinence)
- No urinary or fecal incontinence (Groups without incontinence)
- Cerebral palsy (Groups with children with CP)
- Normal development (Groups with children without CP)
Who cannot join
- Isolated urinary tract infections
- Isolated enuresis
- Isolated dysfunctional voiding
- Isolated fecal incontinence
- Anatomical abnormalities
- History of genitourinary or renal surgery
Show all 9Show fewer
- Medication for incontinence during the last 3 months
- Pelvic reeducation during the last 6 months
- Other neurologic problems influencing continence
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates (risk)factors influencing (in)continence in children with and without a brain injury.
Read the detailed description
Children with cerebral palsy (CP) (Rosenbaum, 2007) gain bladder and bowel control at older age compared to typical developing children (Ozturk, 2006). The incidence of urinary incontinence during day and night, fecal incontinence and constipation is higher in this population.
Incontinence in children is often treated with urotherapy. This is a nonsurgical, nonpharmacological treatment for lower urinary tract dysfunctions. Standard urotherapy is noninterventional and it includes giving information, instructions, advice regarding life-style, fluid intake and bladder diaries. Additionally specific interventions can be used, such as: various forms of pelvic floor training, behavioral modification, biofeedback, electrical stimulation and catheterization (Neveus, 2006). Recent research has proven urotherapy to be successful for the treatment of children with daytime incontinence (Mulders, 2010).
Despite the high prevalence of incontinence in children with CP the possible treatment strategies in this population are poorly investigated. Far too often, urinary incontinence in children with CP is considered a normal, unavoidable and even a minor problem.
Aim: Analyze (risk) factors influencing (in)continence in children with and without CP.
Possible parameters will be registered through questioning, measurement (uroflow combined with pelvic floor EMG and postmictional residue) and retrospective analysis of the patient files. Parameters will be compared between continent and incontinent children with and without CP. This comparison evaluates whether the same therapeutic strategies can be applied in incontinent children with and without CP.
- Conditions
- Urinary Incontinence
- Being tested
- Questionnaire and micturition and drinking diaries, Uroflowmetry, pelvic floor EMG and bladderscan
- Keywords
- Cerebral Palsy, Risk factors, Child, urinary incontinence
- Medical subject headings
- Urinary Incontinence, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and micturition and drinking diariesOther
Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q.
Diaries: 24-hour voiding chart
Uroflowmetry, pelvic floor EMG and bladderscanProcedure or surgery
Voiding variables, pelvic floor activity during micturition and postmictional residue.
| Study group | Role | What they receive |
|---|---|---|
| CP- incontinent | Children with CP and daytime incontinence. Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan. Receives: Other: Questionnaire and micturition and drinking diaries; Procedure: Uroflowmetry, pelvic floor EMG and bladderscan | |
| CP- continent | Children with CP without daytime incontinence. Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan. Receives: Other: Questionnaire and micturition and drinking diaries; Procedure: Uroflowmetry, pelvic floor EMG and bladderscan | |
| NoDev - incontinent | Children with normal development with daytime incontinence. Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan. Receives: Other: Questionnaire and micturition and drinking diaries; Procedure: Uroflowmetry, pelvic floor EMG and bladderscan | |
| NoDev - continent | Children with normal development without daytime incontinence. Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan. Receives: Other: Questionnaire and micturition and drinking diaries; Procedure: Uroflowmetry, pelvic floor EMG and bladderscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors
Identification of predictive factors for incontinence in children with and without CP.
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Van Laecke, PhD MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368262
- Sponsor's protocol ID
- 2011/766.2
- Status last verified
- Jan 2017
- First submitted
- 13 Feb 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02368262
- Acronym / sponsor ID
- 2011/766.2
- Conditions
- Urinary Incontinence
- Keywords
- Cerebral Palsy, Risk factors, Child, urinary incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Feb 2015 (estimated)
- 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.
This study evaluates (risk)factors influencing (in)continence in children with and without a brain injury.
Detailed description
Children with cerebral palsy (CP) (Rosenbaum, 2007) gain bladder and bowel control at older age compared to typical developing children (Ozturk, 2006). The incidence of urinary incontinence during day and night, fecal incontinence and constipation is higher in this population.
Incontinence in children is often treated with urotherapy. This is a nonsurgical, nonpharmacological treatment for lower urinary tract dysfunctions. Standard urotherapy is noninterventional and it includes giving information, instructions, advice regarding life-style, fluid intake and bladder diaries. Additionally specific interventions can be used, such as: various forms of pelvic floor training, behavioral modification, biofeedback, electrical stimulation and catheterization (Neveus, 2006). Recent research has proven urotherapy to be successful for the treatment of children with daytime incontinence (Mulders, 2010).
Despite the high prevalence of incontinence in children with CP the possible treatment strategies in this population are poorly investigated. Far too often, urinary incontinence in children with CP is considered a normal, unavoidable and even a minor problem.
Aim: Analyze (risk) factors influencing (in)continence in children with and without CP.
Possible parameters will be registered through questioning, measurement (uroflow combined with pelvic floor EMG and postmictional residue) and retrospective analysis of the patient files. Parameters will be compared between continent and incontinent children with and without CP. This comparison evaluates whether the same therapeutic strategies can be applied in incontinent children with and without CP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CP- incontinent | – | Other: Questionnaire and micturition and drinking diaries, Procedure: Uroflowmetry, pelvic floor EMG and bladderscanChildren with CP and daytime incontinence. Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan. |
| CP- continent | – | Other: Questionnaire and micturition and drinking diaries, Procedure: Uroflowmetry, pelvic floor EMG and bladderscanChildren with CP without daytime incontinence. Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan. |
| NoDev - incontinent | – | Other: Questionnaire and micturition and drinking diaries, Procedure: Uroflowmetry, pelvic floor EMG and bladderscanChildren with normal development with daytime incontinence. Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan. |
| NoDev - continent | – | Other: Questionnaire and micturition and drinking diaries, Procedure: Uroflowmetry, pelvic floor EMG and bladderscanChildren with normal development without daytime incontinence. Evaluation consisted of a questionnaire and micturition and drinking diaries, uroflowmetry, pelvic floor EMG and bladderscan. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with CP: Cerebral palsy Reference Centre (Ghent university hospital) Incontinent children with normal development: Urology department (Ghent university hospital) continent children with normal development: community sample
Key inclusion criteria (4 listed)
- Daytime urinary incontinence with or without enuresis and/or fecal incontinence (Groups with incontinence)
- No urinary or fecal incontinence (Groups without incontinence)
- Cerebral palsy (Groups with children with CP)
- Normal development (Groups with children without CP)
Key exclusion criteria (9 listed)
- Isolated urinary tract infections
- Isolated enuresis
- Isolated dysfunctional voiding
- Isolated fecal incontinence
- Anatomical abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and micturition and drinking diariesQuestionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q. Diaries: 24-hour voiding chart | Other | CP- continent, CP- incontinent, NoDev - continent, NoDev - incontinent |
| Uroflowmetry, pelvic floor EMG and bladderscanVoiding variables, pelvic floor activity during micturition and postmictional residue. | Procedure or surgery | CP- continent, CP- incontinent, NoDev - continent, NoDev - incontinent |
Primary outcome
Risk factors
Time frame: Cross-sectional
Identification of predictive factors for incontinence in children with and without CP.
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 4 Jan 2017.
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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.
Erik Van Laecke, PhD MD principal investigator
University Hospital, Ghent
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 Urinary Incontinence, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 9 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 4 Jan 2017. 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 Belgium. 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?
Risk factors (time frame: Cross-sectional). 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 4 Jan 2017.