DRUG
Desmopressin
The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).
The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.
Status
Completed
Phase
Phase 4
Enrollment
324
Locations
6
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment efficacy. The hypothesis is that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with MNE and subsequent treatment tailoring improves the response to first-line treatment approach.
Full detailed description
This is a randomized, controlled study. This study will be performed at Aarhus University Hospital (Denmark), Ghent University Hospital (Belgium) and Hospital of Zhengzhou University (China) following the same protocol. According to the initial randomization, children will be allocated to treatment without (group A) or with (group B) prior clinical characterization based on home recordings. Group A: The children will be randomized to either an enuresis alarm or desmopressin without evaluating the home recordings. Group B: The home recordings will be evaluated and treatment will be based on the recordings. Desmopressin will be administered to the children with nocturnal polyuria and the conditional alarm to the children with reduced bladder capacity. Children with nocturnal polyuria and reduced bladder capacity will be treated with both desmopressin and conditional alarm. Children with neither nocturnal polyuria nor reduced bladder capacity will again be randomized to either desmopressin or alarm treatment.
Interventions
Treatment arms and agents.
DEVICE
Conditional alarm
Eight weeks of treatment.
Timeline
From registration to results.
First posted
Jan 3, 2018
Study start
Oct 1, 2017
Primary completion
Jan 3, 2023
Study completion
Jan 3, 2023
Results posted
Not reported
Registry updated
Aug 2, 2023
Outcomes
What the study measures.
Primary outcomes
The number of children who responded to the treatment
Time frame · Eight weeks
Evaluated by home recordings
The number of children achieving complete dryness (complete responders)
Time frame · Eight weeks
Evaluated by home recordings
Secondary outcomes
Change in wet nights
Time frame · Eight weeks
Evaluated by home recordings
Eligibility
Who can take part.
- Minimum age
- 6 Years
- Maximum age
- 14 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Age 6-14 years. * Three or more wet nights per week regarding the home registrations. Exclusion Criteria: * Ongoing constipation and/or faecal incontinence. * Daytime symptoms such as urgency, frequency or incontinence. * Recurrent urinary tract infections. * Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated. * Neurological and/or known clinically significant anatomical abnormalities of the urinary tract. * Former operations in the urinary tract. * Prior or ongoing treatment with alarm, desmopressin or anticholinergics. * Ongoing medication that may interfere with the parameters tested. * Pregnant or lactating girl. * Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatremia or SIADH. * Hypersensitivity / allergy to substances in the tablets.
Study locations
6 registered sites.
Belgium · China · Denmark · Poland. Showing up to 24 locations stored in the fast local snapshot.
Algemeen Ziekenhuis Sint-Jan Brugge
Bruges, Belgium
Ghent University Hospital
Ghent, Belgium
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Aalborg University Hospital
Aalborg, Jylland, Denmark
Aarhus University Hospital
Aarhus, Jylland, Denmark
University Clinical Centre in Gdańsk
Gdansk, Poland
Publications
Results and literature.
PMID 40728007 ↗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 38950376 ↗Jorgensen CS, Dossche L, Zhai R, Maternik M, Kamperis K, Breinbjerg AS, Karamaria S, Thorsteinsson K, Borg B, Wang Y, Li S, Raes A, Wei L, Zurowska A, Hagstrom S, Walle JV, Guo WJ, Rittig S. Development of a Novel Prediction Tool for Response to First-Line Treatments of Monosymptomatic Nocturnal Enuresis: A Randomized, Controlled, International, Multicenter Study (DRYCHILD). J Urol. 2024 Oct;212(4):539-549. doi: 10.1097/JU.0000000000004129. Epub 2024 Jul 1.
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