Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

Rabin Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Nocturnal Enuresis

Interventions

Polyethylene glycol 3350DRUG

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.

Constipation behavioral therapyBEHAVIORAL

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.

UrotherapyBEHAVIORAL

Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute of Gastroenterology, Nutrition and Liver Diseases; Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Outcomes

Primary Outcomes

Number of participants with complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response at week 14

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.

Time frame: 14 weeks

Secondary Outcomes

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.

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.

Time frame: 14 weeks

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.

Sustained complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response at 26 weeks.

Time frame: 26 weeks

Number of participants with adverse effects

Adverse effects of interventions as reported by patients/care givers during visits.

Time frame: 14 weeks

Data from ClinicalTrials.gov

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