Randomized, double-blind, placebo-controlled trial of polyethylene glycol (MiraLAX®) for urinary urge symptoms

Nicol Corbin Bush, Anjana Shah, Theodore Barber, Mary Yang, Ira Bernstein, Warren Snodgrass

Research output: Contribution to journalArticle

9 Citations (Scopus)

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. Patients and 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.

Original languageEnglish (US)
Pages (from-to)597-604
Number of pages8
JournalJournal of Pediatric Urology
Volume9
Issue number5
DOIs
StatePublished - Oct 2013

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Placebos
Overactive Urinary Bladder
Constipation
Therapeutics
Parents
X-Rays
Demography
Surveys and Questionnaires

Keywords

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

ASJC Scopus subject areas

  • Urology
  • Pediatrics, Perinatology, and Child Health

Cite this

Randomized, double-blind, placebo-controlled trial of polyethylene glycol (MiraLAX®) for urinary urge symptoms. / Bush, Nicol Corbin; Shah, Anjana; Barber, Theodore; Yang, Mary; Bernstein, Ira; Snodgrass, Warren.

In: Journal of Pediatric Urology, Vol. 9, No. 5, 10.2013, p. 597-604.

Research output: Contribution to journalArticle

Bush, Nicol Corbin ; Shah, Anjana ; Barber, Theodore ; Yang, Mary ; Bernstein, Ira ; Snodgrass, Warren. / Randomized, double-blind, placebo-controlled trial of polyethylene glycol (MiraLAX®) for urinary urge symptoms. In: Journal of Pediatric Urology. 2013 ; Vol. 9, No. 5. pp. 597-604.
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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. Patients and 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.",
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