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

• Status: Completed
• Trial end date: 2014-07-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Department of Urology
• Treatments: Cathartics; Laxatives; Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• Toilet-trained with a history of urinary tract infection

• Vesicoureteral reflux

• Urinary incontinence

• Daily frequency and urgency

• Diurnal incontinence.

Exclusion Criteria:

• Children who are below 4 years old as they may still not be toilet-trained;

• Children with encopresis

• Children with anorectal malformations

• Children with neurologic disorders