Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome

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.

Conditions

• Constipation

Interventions

DRUG

MiraLAX

Every subject will be given one bottle of the polyethylene glycol/placebo, divided into daily doses and depending on the patient's age, will be instructed to take 8.5 grams or 17 grams of the medication dispensed in daily dose vials to be mixed with water or juice. They will take the medication once a day for one month.

DRUG

Placebos

Every subject will be given one bottle of the polyethylene glycol/placebo, divided into daily doses and depending on the patient's age, will be instructed to take 8.5 grams or 17 grams of the medication dispensed in daily dose vials to be mixed with water or juice. They will take the medication once a day for one month.

Sponsors & Collaborators

• Department of Urology

  collaborator UNKNOWN

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Warren T Snodgrass, MD · PARC Urology

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-10

Primary Completion

2014-06-17

Completion

2014-07-22

FDA Drug

Yes