ConstipationEarly Phase 1NCT00765557
Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
A Early Phase 1 study testing MiraLAX in people with Constipation, run by University of Texas Southwestern Medical Center.
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. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Constipation
- What is being tested?
- MiraLAX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2007to 22 Jul 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Toilet-trained with a history of urinary tract infection
- Vesicoureteral reflux
- Urinary incontinence
- Daily frequency and urgency
- Diurnal incontinence.
Who cannot join
- 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
About this study
HYPOTHESIS:
Is MiraLAX an effective treatment of pediatric urinary urge syndrome?
Read more
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.
Read the 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 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.
- Conditions
- Constipation
- Being tested
- MiraLAX, Placebos
- Keywords
- Bowel and bladder dysfunction, Constipation, MiraLAX, Overactive bladder, Polyethylene glycol, Urinary urgency
- Medical subject headings
- Constipation, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiraLAXDrug
Also called Polyethylene glycol
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.
PlacebosDrug
Also called Dextrose
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.
| Study group | Role | What they receive |
|---|---|---|
| MiraLAX | Active comparator | 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 MiraLAX versus placebo. Receives: Drug: MiraLAX; Drug: Placebos |
| Placebos | Placebo comparator | 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 placebo versus MiraLAX. Receives: Drug: MiraLAX; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in USQ (Urinary Symptom Questionnaire) scores
Vancouver urinary symptom questionnaire (USQ) measures urinary urge symptom with possible score range from 0 (no urge symptoms) to 16 (all 4 symptoms occurring almost always), with higher ΔUSQ demonstrating greater symptom improvement (i.e. less urinary urge symptoms)
Measured: Baseline,1 month
Mean change in BSQ (Bowel Symptom Questionnaire) scores
Bowel symptom questionnaire (BSQ) measures bowel symptoms with possible score range from 0-20 with higher ΔBSQ demonstrating greater symptom improvement
Measured: Baseline, 1 month
Secondary outcomes (1)
Number of patients with constipation
The evidence of constipation was measured by abdominal X-ray (KUB) (kidneys, ureters, and urinary bladder)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study start10 Dec 2007
- Primary completion17 Jun 2014
- Study completion22 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized, double-blind, placebo controlled study was performed to determine whether placebo-controlled versus Polyethylene glycol (MiraLAX) was effective for decreasing OAB symptoms.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Urology
- Responsible party
- Principal investigator, Linda A Baker, University of Texas Southwestern Medical Center
- Investigators
- Warren T Snodgrass, MD, Principal investigator, PARC Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765557
- Sponsor's protocol ID
- STU 122004-038
- Status last verified
- Jan 2021
- First submitted
- 30 Sep 2008
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bush NC, Shah A, Barber T, Yang M, Bernstein I, Snodgrass W. Randomized, double-blind, placebo-controlled trial of polyethylene glycol (MiraLAX(R)) for urinary urge symptoms. J Pediatr Urol. 2013 Oct;9(5):597-604. doi: 10.1016/j.jpurol.2012.10.011. Epub 2012 Nov 3.
PubMed 23127806
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
- ClinicalTrials.gov ID
- NCT00765557
- Acronym / sponsor ID
- STU 122004-038
- Conditions
- Constipation
- Keywords
- Bowel and bladder dysfunction, Constipation, MiraLAX, Overactive bladder, Polyethylene glycol, Urinary urgency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Department of Urology
- Study start
- 10 Dec 2007 (actual)
- Primary completion
- 17 Jun 2014 (actual)
- Study completion
- 22 Jul 2014 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A prospective randomized, double-blind, placebo controlled study was performed to determine whether placebo-controlled versus Polyethylene glycol (MiraLAX) was effective for decreasing OAB symptoms.
| Arm | Type | Receives |
|---|---|---|
| MiraLAX | Active comparator | Drug: MiraLAX, Drug: PlacebosThe 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 MiraLAX versus placebo. |
| Placebos | Placebo comparator | Drug: MiraLAX, Drug: PlacebosThe 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 placebo versus MiraLAX. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Toilet-trained with a history of urinary tract infection
- Vesicoureteral reflux
- Urinary incontinence
- Daily frequency and urgency
- Diurnal incontinence.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiraLAXAlso: Polyethylene glycolEvery 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 | MiraLAX, Placebos |
| PlacebosAlso: DextroseEvery 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 | MiraLAX, Placebos |
Primary outcome
Mean change in USQ (Urinary Symptom Questionnaire) scores
Time frame: Baseline,1 month
Vancouver urinary symptom questionnaire (USQ) measures urinary urge symptom with possible score range from 0 (no urge symptoms) to 16 (all 4 symptoms occurring almost always), with higher ΔUSQ demonstrating greater symptom improvement (i.e. less urinary urge symptoms)
Mean change in BSQ (Bowel Symptom Questionnaire) scores
Time frame: Baseline, 1 month
Bowel symptom questionnaire (BSQ) measures bowel symptoms with possible score range from 0-20 with higher ΔBSQ demonstrating greater symptom improvement
1 secondary outcome
Number of patients with constipation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 23127806Bush NC, Shah A, Barber T, Yang M, Bernstein I, Snodgrass W. Randomized, double-blind, placebo-controlled trial of polyethylene glycol (MiraLAX(R)) for urinary urge symptoms. J Pediatr Urol. 2013 Oct;9(5):597-604. doi: 10.1016/j.jpurol.2012.10.011. Epub 2012 Nov 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren T Snodgrass, MD principal investigator
PARC Urology
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MiraLAX in people with Constipation, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in USQ (Urinary Symptom Questionnaire) scores (time frame: Baseline,1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00765557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.