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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02364063 |
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Date of registration:
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09/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Micturition Reeducation in Children With Cerebral Palsy
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Scientific title:
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Micturition Reeducation in Children With Cerebral Palsy |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02364063 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Erik Van Laecke, PhD MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Ghent |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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)
Exclusion Criteria:
- Isolated urinary tract infections
- Isolated enuresis
- Isolated dysfunctional voiding
- Isolated fecal incontinence
- Anatomical abnormalities
- History of genitourinary or renal surgery
- Medication for incontinence during the last 3 months
- Pelvic reeducation during the last 6 months
- other neurologic problems influencing continence
Age minimum:
5 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Daytime Urinary Incontinence
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Intervention(s)
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Other: urotherapy with or without pharmacotherapy
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Primary Outcome(s)
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Subjective report of change in urinary incontinence measured by questionnaire
[Time Frame: Baseline and 3-6-12 months + follow-up]
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Secondary Outcome(s)
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Drinking behaviour measured by drinking and voiding charts
[Time Frame: Baseline and 6-12 months]
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Constipation/fecal incontinence measured by ROME III criteria
[Time Frame: Baseline and 6-12 months]
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Lower urinary tract symptoms (LUTS) measured by questionnaire
[Time Frame: baseline and 6-12 months]
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voiding variables and pelvic floor activity during micturition measured by uroflow/EMG
[Time Frame: Baseline and 3-6-12 months]
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Secondary ID(s)
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2011/766.1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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