The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal

NCT00226122 | Completed Phase 4

• 2 other identifiers: INDO18120201
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enuresis

Keywords

Enuresis; Nocturnal; Monosymptomatic; DDAVP; Indomethacin; Randomized

Outcome Measures

Primary Outcomes (1)

• Enuresis episodes

  3 and 7 weeks

Secondary Outcomes (1)

• Urine production, electrolyte excretion, hormonal changes

  3 and 7 weeks

Interventions

Indomethacin DRUG

Indomethacin capsules 50 mg

Also known as: Confortid

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Monosymptomatic enuresis nocturnal
• At least 3 nights with enuresis per week
• Incomplete response to dDAVP

You may not qualify if:

• Daytime incontinence
• Urgency
• Frequency
• Other conditions that influence normal urine production

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Dept of Pediatrics, Aarhus University Hospital

Aarhus N, Jutland, 8200, Denmark

Location

Related Publications (2)

• Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2.

  PMID: 40728007 DERIVED

• Kamperis K, Hagstroem S, Faerch M, Mahler B, Rittig S, Djurhuus JC. Combination treatment of nocturnal enuresis with desmopressin and indomethacin. Pediatr Nephrol. 2017 Apr;32(4):627-633. doi: 10.1007/s00467-016-3536-9. Epub 2016 Oct 27.

  PMID: 27787700 DERIVED

MeSH Terms

Conditions

Enuresis

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Konstantinos Kamperis, MD. PhD

  Clinical Institute, University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 26, 2005
• Study Start: January 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 25, 2010

Record last verified: 2010-06

Locations

DK (1)