Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis
- Conditions
- Nocturnal Enuresis
- Interventions
- Registration Number
- NCT02337413
- Lead Sponsor
- Rabin Medical Center
- Brief Summary
Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal enuresis (bed wetting at night). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to stool softening and GI behavioral therapy with reduction of their urinary tract symptoms when added to standard urotherapy.
- 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- WITHDRAWN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.
- MNE as defined by ≥3 wet nights/week without daytime incontinence
- 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 + 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. Urothearpy 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.
- Primary Outcome Measures
Name Time Method Number of participants with complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response at week 14 14 weeks Proportion of patients with uro-therapy + constipation treatment with complete (No nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response in comparison to the isolated urotherapy group.
- Secondary Outcome Measures
Name Time Method Number of participants with complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response of enuresis to treatment in patient subgroups with fecal loading compared to those without fecal loading. 14 weeks Complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) 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.
Number of participants with sustained complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response 12 weeks after the end of the intervention. 26 weeks Sustained complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response at 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