Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
Status:
Completed
Trial end date:
2014-07-22
Target enrollment:
Participant gender:
Summary
HYPOTHESIS:
Is MiraLAX an effective treatment of pediatric urinary urge syndrome?
OBJECTIVE:
Polyethylene glycol (PEG) is common first-line therapy for urinary symptoms despite minimal
evidence-based support. We performed a randomized, double-blind, placebo-controlled study of
PEG for initial treatment of urinary urge symptoms.
SUMMARY:
Only patients of investigators and sub-investigators will be recruited for this study.
Children with urinary incontinence, urinary frequency, diurnal incontinence, Urinary Tract
Infection (UTI) and/or reflux validated by bladder/bowel symptom questionnaire to have Urge
Syndrome (US) are eligible for this study. A standardized questionnaire of bowel/bladder
activity will be administered and a KUB obtained as standard of care at entry to the study. A
standard 1-day voiding diary will be completed at home before beginning therapy. To exclude
patients potentially still in the process of toilet training, only subjects 4 years of age
and older will be studied. Other exclusion criteria will include known neurological
disorders, a diagnosis of attention deficit disorder, bladder symptoms less than 6 months in
duration at presentation, other bladder dysfunctions besides US, a history of anorectal
malformation and pregnancy. Based upon prior experience that patients with encopresis were
not likely to achieve improved stooling with only a few weeks of laxative therapy, they will
also be excluded.
Those accepted into the study will be randomized to receive either laxative or placebo once
daily for one month. Preparation of the laxative and placebo and patient randomization will
be performed by the Children's Medical Center Investigational Drug Pharmacist. Premixed study
medications will be available at the Urology clinic ready to be dispensed to the patient by
the study coordinator after being screened and randomized. Dosage includes children age 4-6
years (8.5 gms) and children 7-10 years (17gms). The medication will be divided into daily
doses by the Investigational Pharmacist. Written and verbal instructions, both in English and
Spanish, will be provided to the parents/guardian of the subjects.
The Investigational Drug Pharmacist will be blinded to all patient data, and physicians and
nurses evaluating patients will be blinded to randomization of these patients to laxative
versus placebo arms.