Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00765557
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2008-09-30
Brief Title:
Randomized Double-Blinded Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Randomized Double-Blinded Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor reflux validated by bladderbowel symptom questionnaire to have Urge Syndrome US are eligible for this study A standardized questionnaire of bowelbladder 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 Childrens 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 85 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 parentsguardian 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
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 andor reflux validated by bladderbowel symptom questionnaire to have Urge Syndrome US are eligible for this study A standardized questionnaire of bowelbladder 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 Childrens 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 85 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 parentsguardian 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
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 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None