The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal
Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Enuresis
Intervention: Indomethacin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Konstantinos Kamperis, MD. PhD, Principal Investigator, Affiliation: Clinical Institute, University of Aarhus
Overall contact:
Konstantinos Kamperis, MD, PhD, Phone: +45 89496773, Email: kostas.kamperis@ki.au.dk
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.
Clinical Details
Official title: The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Enuresis episodes
Secondary outcome: Urine production, electrolyte excretion, hormonal changes
Detailed description:
The "in-patient" phase is a comparative circadian study of three groups of participants and
a non-placebo controlled study of the renal effects of indomethacin with special reference
the renal handling of sodium.
The ambulatory phase is designed as a randomized double blind, crossover placebo controlled
for indomethacin study of the efficacy and safety of a combination treatment with
indomethacin and dDAVP.
In-patient phase: Primary effect parameters will be the diuresis, urinary osmolality, sodium
excretion prior to and after the administration of indomethacin.
Secondary effect parameters will be the following: GFR, K+ excretion, creatinine excretion,
urea excretion, as well as urinary concentrations of aquaporin 2 (AQP2), PGE2, AVP, URO,
Na-transporter protein, concentration of renin, ANG II, ALDO, ANP, in plasma, prior to and
after the administration of indomethacin.
Ambulatory phase: Primary effect parameter will be the number of dry nights achieved in the
two treatment periods. Secondary effect parameters will be the nocturnal urine production,
and the enuresis volumes In-patient phase: Day-night ratios will be calculated for all
parameters tested. The circadian rhythm of hormones blood pressure and electrolyte excretion
will be analyzed using COSINOR analysis.
The effect of indomethacin on the parameters tested will be compared to the basal
measurements using student's t-test, ANOVA for repeated measurements or non-parametric
tests. All statistical inference will take place on a "protocol population" basis.
Ambulatory phase: The efficacy of the combination treatment will be tested against placebo
(only for indomethacin) with help of student's t-test, x2 test or non-parametric tests.
The results from the home recordings will be compared for the two treatment periods using
non-parametric tests. The effect parameters that will undergo statistical analysis are the
number of wet nights, the enuresis volume and the nocturnal urine production. The analysis
will be on the basis of intention to treat population.
Eligibility
Minimum age: 7 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Monosymptomatic enuresis nocturnal
- At least 3 nights with enuresis per week
- Incomplete response to dDAVP
Exclusion Criteria:
- Daytime incontinence
- Urgency
- Frequency
- Other conditions that influence normal urine production
Locations and Contacts
Konstantinos Kamperis, MD, PhD, Phone: +45 89496773, Email: kostas.kamperis@ki.au.dk
Dept of Pediatrics, Aarhus University Hospital, Aarhus N, Jutland 8200, Denmark; Recruiting
Konstantinos Kamperis, MD, PhD, Phone: +4589496773, Email: kostas.kamperis@ki.au.dk
Additional Information
Starting date: January 2003
Ending date: December 2009
Last updated: September 3, 2009
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