title: Placebo-controlled study of the effects of atomoxetine on bladder control in children with nocturnal enuresis.
abstract: BACKGROUND
  Nocturnal enuresis is a condition in which children at least 5 years of age are incontinent of urine at night. Atomoxetine, a potent inhibitor of the presynaptic norepinephrine transporter, is used to treat attention-deficit/hyperactivity disorder (ADHD). This study tested the hypothesis that atomoxetine will provide significant therapeutic benefit for nocturnal enuresis in patients with the diagnosis of nocturnal enuresis.
  
  
  METHODS
  Atomoxetine's efficacy for improving nocturnal enuresis was studied in 87 pediatric subjects using an outpatient, multicenter, randomized, double-blind, parallel, placebo-controlled study. Efficacy was determined by measuring the mean number of dry nights per week using an intent-to-treat analysis of the primary outcome measure, the Dry Night Log-Parent Report (DNL-PR), a daily parent diary.
  
  
  RESULTS
  Baseline and end point DNL-PR data were available from 42 atomoxetine-treated and 41 placebo-treated subjects. Atomoxetine increased the average number of dry nights per week by 1.47 compared with .60 for placebo (F = 7.06; df = (1, 75); p = 0.01). Fifteen atomoxetine-treated subjects (35.7%) had an increase of at least 2 dry nights per week compared with only 6 (14.6%) placebo-treated subjects (Fisher's exact test; p = 0.042). There were no significant differences in adverse events between the groups.
  
  
  CONCLUSIONS
  Compared with placebo, atomoxetine treatment was associated with a significant increase in dry nights in children with nocturnal enuresis.
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA. sumner_calvin@lilly.com
authors.forename: Calvin R
authors.initials: CR
authors.lastname: Sumner
authors.forename: Kory J
authors.initials: KJ
authors.lastname: Schuh
authors.forename: Virginia K
authors.initials: VK
authors.lastname: Sutton
authors.forename: Robert
authors.initials: R
authors.lastname: Lipetz
authors.forename: Douglas K
authors.initials: DK
authors.lastname: Kelsey
mesh_terms: D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000375:Aging / Q000523:psychology; D000069445:Atomoxetine Hydrochloride; D002648:Child; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects; D004775:Enuresis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D010290:Parents; D011437:Propylamines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride