Daytime Urinary IncontinenceNCT02364063
Micturition Reeducation in Children With Cerebral Palsy
A study testing urotherapy with or without pharmacotherapy in people with Daytime Urinary Incontinence, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study evaluates the effectiveness of a voiding reeducation program as treatment for incontinence in children with a brain injury. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Daytime Urinary Incontinence
- What is being tested?
- urotherapy with or without pharmacotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Child
Who may be able to join
- Daytime urinary incontinence with or without enuresis and/or fecal incontinence
- Cerebral palsy (Arms of children with CP)
- Normal development (Arms of 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 the effectiveness of a voiding reeducation program as treatment for incontinence in children with 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: Investigate the influence of individualized urotherapy on the (in)continence of children with CP.
The included children with CP will be randomized and stratified for type of CP and mental abilities into 2 groups: the intervention group and the control group. The intervention group will receive immediate therapy. After one year of therapy, a follow- up of 6 months will be applied. The control group will start 6 months later and information will be used as control group. Incontinent children without CP will receive therapy and will also act as control group.
- Conditions
- Daytime Urinary Incontinence
- Being tested
- urotherapy with or without pharmacotherapy
- Keywords
- Urinary incontinence, cerebral palsy, urotherapy, child
- Medical subject headings
- Diurnal Enuresis, Urinary Incontinence, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urotherapy with or without pharmacotherapyOther
Individualized
| Study group | Role | What they receive |
|---|---|---|
| Children with CP - Therapy | Experimental | Children receive incontinence treatment during one year, after which a follow-up period of 6 months will be applied. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy Receives: Other: urotherapy with or without pharmacotherapy |
| Children with CP - Control | No intervention | Children are followed for 6 months, not receiving any treatment. After this follow-up period, children also receive incontinence treatment for 6 months. |
| Children without CP | Active comparator | Children receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy Receives: Other: urotherapy with or without pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective report of change in urinary incontinence measured by questionnaire
Measured: Baseline and 3-6-12 months + follow-up
Secondary outcomes (4)
Lower urinary tract symptoms (LUTS) measured by questionnaire
Measured: baseline and 6-12 months
Drinking behaviour measured by drinking and voiding charts
Measured: Baseline and 6-12 months
Constipation/fecal incontinence measured by ROME III criteria
Measured: Baseline and 6-12 months
voiding variables and pelvic floor activity during micturition measured by uroflow/EMG
Uroflow and pelvic floor EMG + postmictional residue
Measured: Baseline and 3-6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Daytime 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT02364063
- Sponsor's protocol ID
- 2011/766.1
- Status last verified
- Jan 2017
- First submitted
- 9 Feb 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Samijn B, Van den Broeck C, Plasschaert F, Pascal A, Deschepper E, Hoebeke P, Van Laecke E. Incontinence training in children with cerebral palsy: A prospective controlled trial. J Pediatr Urol. 2022 Aug;18(4):447.e1-447.e9. doi: 10.1016/j.jpurol.2022.05.014. Epub 2022 May 25.
PubMed 35732572
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
- Micturition Reeducation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02364063
- Acronym / sponsor ID
- 2011/766.1
- Conditions
- Daytime Urinary Incontinence
- Keywords
- Urinary incontinence, cerebral palsy, urotherapy, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 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
- 16 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 the effectiveness of a voiding reeducation program as treatment for incontinence in children with 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: Investigate the influence of individualized urotherapy on the (in)continence of children with CP.
The included children with CP will be randomized and stratified for type of CP and mental abilities into 2 groups: the intervention group and the control group. The intervention group will receive immediate therapy. After one year of therapy, a follow- up of 6 months will be applied. The control group will start 6 months later and information will be used as control group. Incontinent children without CP will receive therapy and will also act as control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with CP - Therapy | Experimental | Other: urotherapy with or without pharmacotherapyChildren receive incontinence treatment during one year, after which a follow-up period of 6 months will be applied. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy |
| Children with CP - Control | No intervention | –Children are followed for 6 months, not receiving any treatment. After this follow-up period, children also receive incontinence treatment for 6 months. |
| Children without CP | Active comparator | Other: urotherapy with or without pharmacotherapyChildren receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Daytime urinary incontinence with or without enuresis and/or fecal incontinence
- Cerebral palsy (Arms of children with CP)
- Normal development (Arms of 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 |
|---|---|---|
| urotherapy with or without pharmacotherapyIndividualized | Other | Children with CP - Therapy, Children without CP |
Primary outcome
Subjective report of change in urinary incontinence measured by questionnaire
Time frame: Baseline and 3-6-12 months + follow-up
4 secondary outcomes
Lower urinary tract symptoms (LUTS) measured by questionnaire
Time frame: baseline and 6-12 months
Drinking behaviour measured by drinking and voiding charts
Time frame: Baseline and 6-12 months
Constipation/fecal incontinence measured by ROME III criteria
Time frame: Baseline and 6-12 months
voiding variables and pelvic floor activity during micturition measured by uroflow/EMG
Time frame: Baseline and 3-6-12 months
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.
- Derived from this study: PubMed 35732572Samijn B, Van den Broeck C, Plasschaert F, Pascal A, Deschepper E, Hoebeke P, Van Laecke E. Incontinence training in children with cerebral palsy: A prospective controlled trial. J Pediatr Urol. 2022 Aug;18(4):447.e1-447.e9. doi: 10.1016/j.jpurol.2022.05.014. Epub 2022 May 25.
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RecruitingObservational study
The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents - the PpUF-study.
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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?
A study testing urotherapy with or without pharmacotherapy in people with Daytime 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 3 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?
Subjective report of change in urinary incontinence measured by questionnaire (time frame: Baseline and 3-6-12 months + follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02364063, which also lists 1 linked publication.
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.