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

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ClinicalTrials.gov Identifier: NCT00765557
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Warren Snodgrass, University of Texas Southwestern Medical Center

Brief Summary:

We hypothesize fecal retention is the primary source of bladder dysfunction in some children with Urge Syndrome. Our specific aims are:

  1. To test this hypothesis through a prospective, randomized, double-blinded and placebo-controlled trial of laxatives for children diagnosed with US.
  2. To determine if a validated questionnaire of bowel activity administered to the family, and when appropriate, the patient, will identify those likely to benefit from laxative therapy for bladder dysfunction.
  3. To determine if the abdominal X-Ray of the kidneys, ureters and bladder (KUB) assessment of fecal loading corresponds to answers on the questionnaire regarding incidence of constipation, and/or response to laxative therapy for US.

Condition or disease Intervention/treatment Phase
Urge Syndrome Drug: Miralax Not Applicable

Detailed 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 month intervals 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.

Agent/Device: Once the child has been screened and randomized, he/she will be given a 24-hour Voiding Diary to be started one day before the treatment. After the completion of the 24-hour voiding diary, the child will start taking the study medication (polyethylene glycol/placebo) as directed by age group for one month.

After the child has taken the study medication (polyethylene glycol/placebo), he/she will fill out another 24-hour voiding diary and will come back to the clinic to be evaluated by the study doctor. The parent/guardian and/or the child will fill out the Bladder/Bowel Questionnaire again. Another abdominal X-ray of the kidneys, ureters and bladder (KUB) will be done as a standard of care procedure on the second clinic visit.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Only patients of investigators and sub-investigators will be recruited for this study. Children with urinary incontinence, urinary frequency, diurnal incontinence, UTIs and/or reflux validated by bladder/bowel symptom questionnaire to have Urge Syndrome (US) are eligible for this study. Standardized questionnaire of bowel/bladder activity will be given and a KUB obtained, standard of care, at entry to the study. A standard 1-day voiding diary will be completed at home before beginning therapy. Only subjects 4 years of age and older will be studied. Exclusion criteria also includes known neurological disorders, a diagnosis of attention deficit disorder, bladder symptoms less than 6 months in duration at presentation, other bladder dysfunctions besides US, history of anorectal malformation, pregnancy and encopresis. Those accepted into the study will be randomized to receive either laxative or placebo once daily for one month.
Masking: Double (Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
Actual Study Start Date : December 10, 2007
Actual Primary Completion Date : June 17, 2014
Actual Study Completion Date : July 22, 2014

Arm Intervention/treatment
Placebo Comparator: Randomization
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
Drug: Miralax
Every subject will be given one bottle of the laxative/placebo, and depending on the patient's weight, will be instructed to take 1-3 tsps (.75 gm/kg) of the medication daily.

Active Comparator: Miralax
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
Drug: Miralax
Every subject will be given one bottle of the laxative/placebo, and depending on the patient's weight, will be instructed to take 1-3 tsps (.75 gm/kg) of the medication daily.





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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Toilet-trained with a history of urinary tract infection; vesicoureteral reflux; urinary incontinence; daily frequency and urgency; and 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; and children with neurologic disorders.

Publications:
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Responsible Party: Warren Snodgrass, Professor of Urology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00765557     History of Changes
Other Study ID Numbers: 122004-038
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Keywords provided by Warren Snodgrass, University of Texas Southwestern Medical Center:
Laxative therapy
URGE Syndrome
Pediatric constipation

Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes
Laxatives
Polyethylene glycol 3350
Cathartics
Gastrointestinal Agents