Nocturnal Enuresis
Conditions
Keywords
Constipation
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.
Interventions
BEHAVIORALUrotherapy
Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.
DRUGPolyethylene glycol 3350
Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and then will be stepped down to 0.8gr/kg subsequently and tapered accoriding to stool consistency and frequency.
BEHAVIORALConstipation behavioral therapy
Patients in the active group will receive dietary instruction as to fiber content, as well as behavioral therapy including active sitting on the toilet to attempt defaction following meals.
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 5-17 years at time of signing of informed consent. 2. MNE as defined by ≥3 wet nights/week without daytime incontinence 3. Do not meet Rome III criteria for functional constipation
Exclusion criteria
1. Inability to provide signed informed consent. 2. Inability to comply with the study protocol. 3. Neurogenic bladder 4. Attention Deficit Disorder (ADD or ADHD) on medical treatment. 5. Known significant sacral, perineal, or other congenital or surgical defect. 6. 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) 7. Patient taking medicinal drugs which can cause urinary incontinence or constipation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Israel
Outcome results
None listed