Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction
- Conditions
- Diurnal Enuresis
- Interventions
- Registration Number
- NCT02336906
- Lead Sponsor
- Rabin Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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)
- Patient taking medicinal drugs which can cause urinary incontinence or constipation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Urotherapy + Constipation Treatment Urotherapy This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction. Urotherapy alone Urotherapy This group will receive standard behavioral urotherapy alone. Urotherapy + Constipation Treatment polyethylene glycol 3350 This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction. Urotherapy + Constipation Treatment Constipation behavioral therapy This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.
- Primary Outcome Measures
Name Time Method Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention. 14 weeks
- Secondary Outcome Measures
Name Time Method Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response in patient subgroups with fecal loading compared to those without fecal loading. 14 weeks Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response to therapy in those with radiological evidence of fecal loading on enrollment abdominal x-ray (as defined by rectal/pelvic outlet ratio, Leech score, and Barr score) compared to those who did not in the intervention group and the urotherapy group
Sustained Response - Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response 12 weeks after intervention has ended. 26 weeks Number of participants with adverse effects 14 weeks Adverse effects of interventions as reported by patients/care givers during visits
Trial Locations
- Locations (1)
Institute of Gastroenterology, Nutrition, and Liver Diseases; Schneider Children's Medical Center of Israel
🇮🇱Petach Tikva, Israel