Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfu… (NCT02336906) | Clinical Trial Compass
WithdrawnPhase 4
Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction
Stopped: Changes in departmental staff have led to a cut in research alotments.
Israel0Started 2020-01
Plain-language summary
Constipation treatment has been found to ameliorate symptoms in some patients with lower urinary tract dysfunction (including day time or combined day time/night time urinary incontinence). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to anti-constipation treatment with reduction of their urinary tract symptoms. Assessment of severity and response of lower urinary tract dysfunction will be based on the Vancouver NULTD/DES questionnaire.
Who can participate
Age range5 Years – 17 Years
SexALL
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Inclusion criteria
✓. Aged 5-17 years at time of signing of informed consent.
✓. Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of \>11 on the Vancouver Questionnaire .
✓. Do not meet Rome III criteria for functional constipation.
Exclusion criteria
✕. Inability to provide signed informed consent.
✕. Inability to comply with the study protocol.
✕. Neurogenic bladder
✕. Attention Deficit Disorder (ADD or ADHD) on medical treatment.
✕. Known significant sacral, perineal, or other congenital or surgical defect.
✕. Known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis)
✕
What they're measuring
1
Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.