Urotherapy vs. Urotherapy With Constipation Treatment for Children With Lower Urinary Tract Dysfunction

Rabin Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Diurnal Enuresis

Interventions

polyethylene glycol 3350DRUG

Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and the stepped down to 0.8gr/kg subsequently tapered according to stool consistency and frequency.

Constipation behavioral therapyBEHAVIORAL

Patients in the active group will receive dietary instruction as to fiber content, as well as behavior therapy including active sitting on the toilet to attempt defacation following meals.

UrotherapyBEHAVIORAL

The children 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. Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of \>11 on the Vancouver Questionnaire . 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

Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.

Time frame: 14 weeks

Secondary Outcomes

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.

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

Time frame: 14 weeks

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.

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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