EnuresisPhase 4NCT00226122
The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal
A Phase 4 study testing Indomethacin in people with Enuresis, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Enuresis
- What is being tested?
- Indomethacin
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2003to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Monosymptomatic enuresis nocturnal
- At least 3 nights with enuresis per week
- Incomplete response to dDAVP
Who cannot join
- Daytime incontinence
- Urgency
- Frequency
- Other conditions that influence normal urine production
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of Pediatrics, Aarhus University Hospital
Aarhus N, Jutland, 8200
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Enuresis
- Being tested
- Indomethacin
- Keywords
- Enuresis, Nocturnal, Monosymptomatic, DDAVP, Indomethacin, Randomized
- Medical subject headings
- Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndomethacinDrug
Also called Confortid
Indomethacin capsules 50 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
Enuresis episodes
Measured: 3 and 7 weeks
Secondary outcomes (1)
Urine production, electrolyte excretion, hormonal changes
Measured: 3 and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EnuresisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Konstantinos Kamperis, MD. PhD, Principal investigator, Clinical Institute, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226122
- Sponsor's protocol ID
- INDO181202
- Other IDs
- 01
- Status last verified
- Jun 2010
- First submitted
- 23 Sep 2005
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40728007Kamperis 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.
PubMed 27787700
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal
- ClinicalTrials.gov ID
- NCT00226122
- Acronym / sponsor ID
- INDO181202
- Conditions
- Enuresis
- Keywords
- Enuresis, Nocturnal, Monosymptomatic, DDAVP, Indomethacin, Randomized
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Monosymptomatic enuresis nocturnal
- At least 3 nights with enuresis per week
- Incomplete response to dDAVP
Key exclusion criteria (4 listed)
- Daytime incontinence
- Urgency
- Frequency
- Other conditions that influence normal urine production
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IndomethacinAlso: ConfortidIndomethacin capsules 50 mg | Drug | – |
Primary outcome
Enuresis episodes
Time frame: 3 and 7 weeks
1 secondary outcome
Urine production, electrolyte excretion, hormonal changes
Time frame: 3 and 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2010.
- Derived from this study: PubMed 40728007Hahn 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.
- Derived from this study: PubMed 27787700Kamperis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Kamperis, MD. PhD principal investigator
Clinical Institute, University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indomethacin in people with Enuresis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enuresis episodes (time frame: 3 and 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00226122, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2010.