Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00765557 |
Other study ID # |
STU 122004-038 |
Secondary ID |
|
Status |
Completed |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
December 10, 2007 |
Est. completion date |
July 22, 2014 |
Study information
Verified date |
January 2021 |
Source |
University of Texas Southwestern Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Urge Syndrome (US) is the most common non-neurogenic voiding dysfunction in children beyond
the usual age for toilet training, and is characterized by urinary frequency and urgency,
holding maneuvers, and diurnal incontinence. Urodynamics testing has determined these
symptoms result from uninhibited bladder contractions, and so anticholinergic drugs that
control these contractions are the mainstay of therapy typically given in six monthintervals
until the condition resolves. Beyond the embarrassment that may accompany urinary
incontinence, US has been linked to urinary tract infection (UTI) and vesicoureteral reflux.
Specifically, among females with UTI, at least 40% also have US, and US has been identified
as a cause for reflux and a factor that delays its otherwise expected spontaneous resolution.
Consequently, identification and treatment of US are important to the management of children
with UTI, reflux and/or incontinence.
Constipation also has been associated with UTI, vesicoureteral reflux, and urinary
incontinence in children. Although these observations date at least to the 1950s, relatively
few studies have attempted either to establish the incidence of constipation found with these
various pediatric urologic conditions, or to document the impact of bowel therapy upon their
management. Of these, Yazbeck et al studied 47 children with recurrent UTI and noted all were
constipated and had uninhibited bladder contractions during urodynamics testing. Therapy
directed toward relief of constipation resolved bladder symptoms in 25%. Loening-Baucke
reported 46% of 234 children attending a university-based encopresis clinic also experienced
urinary incontinence, which diminished with laxative therapy. A recent evaluation of 582
children with US estimated that 16% were also constipated based upon a history of bowel
activity.
We have been concerned about the apparent association between US and constipation, especially
since anticholinergic drugs commonly prescribed for uninhibited bladder contractions could
exacerbate underlying stool retention and thereby prolong bladder dysfunction. It is also our
experience that parents are not very familiar with bowel activity of their children after the
usual age of toilet training, making history potentially unreliable for diagnosing
constipation. Therefore, we started recommending a brief course of laxatives for all patients
presenting with US, reserving anticholinergics for those whose bladder symptoms persisted. In
a retrospective review of 110 children, we found 34% had relief of bladder symptoms with
laxatives alone, so that anticholinergic medications were not then required, and the history
of whether the child was constipated or not did not predict response. However, this study has
been criticized for not being placebo-controlled.
Given the potential impact of this observation for the management of children with not only
urinary incontinence but also UTI and reflux who have US, we now propose a prospective,
randomized, double-blinded, placebo-controlled study of the impact of laxative therapy upon
children with US.