Comparison between imipramine and imipramine combined with pseudoephedrine in
5-12-year-old children with uncomplicated enuresis: a double-blind clinical
trial.
Author(s): Abedin Zadeh M, Moslemi MK, Kholaseh Zadeh G.
Affiliation(s): Department of Urology, Moradi Hospital, School of Medicine, Rafsanjan Medical
Sciences University, Rafsanjan, Iran.
Publication date & source: 2011, J Pediatr Urol. , 7(1):30-3
OBJECTIVE: Monosymptomatic nocturnal enuresis is a common entity, with a
prevalence of 10% at the age of 7 years. For its primary treatment, we compared
the effect of combination medical therapy (imipramine with pseudoephedrine) with
imipramine alone.
MATERIALS AND METHODS: In this one-center prospective double-blind clinical
trial, 100 school-age children (age range 5-12 years) were enrolled. They were
divided into two groups, comparable in terms of age and other demographic
factors: (A) adjusted doses of a combination of imipramine with pseudoephedrine,
and (B) imipramine with placebo were administered. Improvement was defined as
less than 2 wet nights per week.
RESULTS: Four weeks after drug withdrawal, the response rate was 74% in group A
in comparison to 52% in group B, this difference being statistically significant.
There was a recurrence of enuresis in both groups during the 4 weeks after
treatment was discontinued (10% increase in group A and 8% increase in group B).
CONCLUSION: The additive pharmacologic effects of imipramine with pseudoephedrine
for the treatment of monosymptomatic nocturnal enuresis in children were well
tolerated, and gave significantly faster results than single drug therapy using
imipramine. The moderate-to-high recurrence rate following discontinuation of
medical treatment indicates the need for a longer term study involving more
cases.
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