Comparison between imipramine and imipramine combined with pseudoephedrine in 5-12-year-old children with uncomplicated enuresis: a double-blind clinical trial.
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.


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).


CONCLUSIONS
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.
Abedin Zadeh
Mehdi
M
Department of Urology, Moradi Hospital, School of Medicine, Rafsanjan Medical Sciences University, Rafsanjan, Iran.
Moslemi
Mohammad Kazem
MK
Kholaseh Zadeh
Golrasteh
G
D000929:Antidepressive Agents, Tricyclic / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007099:Imipramine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D053206:Nocturnal Enuresis / Q000188:drug therapy*; D011446:Prospective Studies; D054199:Pseudoephedrine / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D013566:Sympathomimetics / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000929:Antidepressive Agents, Tricyclic; D013566:Sympathomimetics; D054199:Pseudoephedrine; D007099:Imipramine