drugset / Trial / NCT00226122

The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal

NCT00226122 ↗

Phase 4 Completed 56 enrolled University of Aarhus
RandomizedCrossoverTriple-blindTreatment

Summary

Monosymptomatic nocturnal enuresis, defined as the involuntary loss of urine during the night at an age where voluntary bladder control should have been attained and on the background of normal urinary tract function, is a rather common disease of childhood with an estimated prevalence of 5-10% at tha age of 7 and a spontaneous remission rate of 15% per year. The present study consists of two phases; an in-patient phase and an ambulatory phase. In the in-patient phase we will examine the regulation of sodium and the circadian rhythm of the hormones that affect this regulation in children with enuresis nocturnal and healthy children, as well as the impact of indomethacin on renal water and electrolyte excretion. In the ambulatory phase we will examine the efficacy and safety of a treatment modality consisting of a combination of dDAVP and indomethacin in patients with severe enuresis where dDAVP as monotherapy is inadequate. A significant number of children with enuresis and nocturnal polyuria do not respond to treatment with dDAVP. If a combination treatment with dDAVP and indomethacin proves superior to dDAVP alone the regimen could readily be used in those difficult to cure cases of enuresis.

Timeline

Start
2003-01
Primary completion
2009-12
Completion
2009-12

Outcome

Mixed primary results

paper The number of dry nights achieved and reduction in the nocturnal urine output were the main effect parameters. PMID 27787700 ↗

paper The addition of indomethacin to desmopressin significantly reduced nocturnal urine output (from 324 ± 14 ml to 258 ± 13 ml, p < 0.001). PMID 27787700 ↗

paper we found no statistically significant reduction in enuresis frequency (from 68 % ± 0.1 to 56 % ± 0.1, p = 0.24). PMID 27787700 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Indomethacin Small molecule 50 mg —

Indications