title: Randomized, double-blind, placebo-controlled trial of polyethylene glycol (MiraLAX®) for urinary urge symptoms.
abstract: 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 overactive bladder (OAB) symptoms in children.
  
  
  METHODS
  Patients aged >3 years underwent baseline urinary symptom questionnaire (USQ, scored 0-16), bowel symptom questionnaire (scored 0-20) and abdominal X-ray (KUB). Patients were randomized to placebo/PEG regardless of parent's perception of constipation. After 1 month, patients completed follow-up questionnaires and KUB. Improvement was defined as decrease in USQ (ΔUSQ) ≥ 3 points. Secondary analyses compared urinary and bowel symptoms to KUB.
  
  
  RESULTS
  Of 138 enrolled patients, 71 (51.4%) completed 1 month of therapy. Analyses of those randomized to placebo vs. PEG and non-completers demonstrated similar demographics, baseline symptoms, and KUB. Patients treated with placebo and PEG both had significant improvement in USQ scores (p < 0.0001). Patients treated with placebo and PEG responded similarly to placebo (ΔUSQ 3.7 vs. 3.4, p = 0.773), with improvement in nearly half (48.5% PEG vs. 44.7% placebo). There was no correlation between KUB and urinary or bowel symptoms.
  
  
  CONCLUSIONS
  Nearly 50% of patients with urinary urge symptoms treated with either placebo or PEG for 1 month had improvement in urinary symptoms. KUB did not correlate with baseline or follow-up urinary or bowel symptoms.
authors.affiliation: Department of Pediatric Urology, University of Texas Southwestern Medical Center, Dallas, TX 75207, USA. nicol.bush@childrens.com
authors.forename: Nicol Corbin
authors.initials: NC
authors.lastname: Bush
authors.forename: Anjana
authors.initials: A
authors.lastname: Shah
authors.forename: Theodore
authors.initials: T
authors.lastname: Barber
authors.forename: Mary
authors.initials: M
authors.lastname: Yang
authors.forename: Ira
authors.initials: I
authors.lastname: Bernstein
authors.forename: Warren
authors.initials: W
authors.lastname: Snodgrass
mesh_terms: D002648:Child; D002675:Child, Preschool; D003248:Constipation / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054368:Laxatives / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D053202:Urinary Incontinence, Urge / Q000188:drug therapy*
chemical_list: D054368:Laxatives; D011092:Polyethylene Glycols
keywords: Bowel and bladder dysfunction; Constipation; MiraLAX; Overactive bladder; Polyethylene glycol; Urinary urgency