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| |  Ibuprofen Shows Benefit as Bedwetting Treatment: Presented at PAS By Jill Stein BALTIMORE, Md -- May 4, 2009 -- Daily use of ibuprofen seems to improve the symptoms of primary nocturnal enuresis, according to results presented here at the 2009 Pediatric Academic Societies (PAS) Annual Meeting. Lead investigator Cathy K. Gelotte, PhD, McNeil Consumer Healthcare, Fort Washington, Pennsylvania, presented data here on May 2 from a randomised, double-blind, placebo-controlled study that evaluated ibuprofen (12.5 mg/kg) and pseudoephedrine (15 or 30 mg), alone and in combination. Treatments were given at nighttime for 2 weeks. The trial enrolled 318 children from 6 to 11 years of age who had at least 8 wet nights during a 2-week baseline period. Children were otherwise healthy, with normal height and weight, likely to be compliant, and, if a female had reached menarche, had a negative urine pregnancy test. In the study, caregivers used a daily diary to document whether the child was wet or dry each night. The primary efficacy endpoint was the mean reduction in the number of wet nights from the 2-week baseline period to the 2-week treatment period. The 4 treatment groups had similar baseline demographic and clinical characteristics. Results showed that children in the ibuprofen-alone and ibuprofen-and-pseudoephedrine combined groups had larger mean decreases from baseline in the number of wet nights compared to placebo-treated children (2.9, 2.9, and 1.4 nights, respectively; P < .005). The mean decrease in the number of wet nights seen with pseudoephedrine alone (1.8 nights) did not differ significantly from placebo. Children in the ibuprofen-alone and ibuprofen-and-pseudoephedrine combined groups also had larger mean percentage decreases in number of wet nights compared with children assigned to placebo (26%, 28%, and 12%, respectively). Treatment responders had larger mean bladder capacities and larger mean percentages of predicted bladder capacities than the children not responding in each treatment group. All treatments were well tolerated. In fact, there were no statistically significant differences among treatment groups in the incidence of adverse effects. Overall, the investigators said, the results showed that ibuprofen had a favourable effect on nighttime bedwetting compared to placebo in paediatric patients, while pseudoephedrine did not. The addition of pseudoephedrine to ibuprofen did not strengthen or lessen ibuprofen's efficacy. Primary nocturnal enuresis is usually defined as intermittent urinary incontinence that occurs only while sleeping at least twice a week for at least 3 months in children at least 5 years of age, with no periods of untreated nighttime dryness that lasted 6 months. Ibuprofen and pseudoephedrine, alone or in combination, are not currently approved to treat primary nocturnal enuresis. Available treatments are usually targeted to and based on the causes of bedwetting (ie, nocturnal urine production, bladder capacity, sleep arousal, and balance between bladder filling and spontaneous micturition). Funding for this study was provided by McNeil Consumer Healthcare. [Presentation title: A Randomized, Placebo-Controlled, Exploratory Trial of Ibuprofen and Pseudoephedrine in the Treatment of Primary Nocturnal Enuresis in Children. Abstract 2804.40]
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