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

NCT00765557 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STU 122004-038
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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) 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.

Conditions

Constipation

Keywords

Bowel and bladder dysfunction; Constipation; MiraLAX; Overactive bladder; Polyethylene glycol; Urinary urgency

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  Baseline, 1 month

Secondary Outcomes (1)

• Number of patients with constipation

  1 month

Study Arms (2)

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.

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.

Drug: MiraLAX; Drug: Placebos

Interventions

MiraLAX DRUG

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.

Also known as: Polyethylene glycol

MiraLAX; Placebos

Placebos DRUG

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.

Also known as: Dextrose

MiraLAX; Placebos

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Toilet-trained with a history of urinary tract infection
• Vesicoureteral reflux
• Urinary incontinence
• Daily frequency and urgency
• Diurnal incontinence.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Department of Urology: collaborator

Related Publications (1)

• 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.

  PMID: 23127806 BACKGROUND

MeSH Terms

Conditions

Constipation; Urinary Bladder, Overactive

Interventions

polyethylene glycol 3350; Polyethylene Glycols; Glucose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Warren T Snodgrass, MD

  PARC Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 3, 2008
• Study Start: December 10, 2007
• Primary Completion: June 17, 2014
• Study Completion: July 22, 2014
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share