A Phase 4 interventional study of Desmopressin and Conditional alarm in Enuresis, Nocturnal, sponsored by University of Aarhus. Completed at 6 sites in 4 countries. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Children will receive desmopressin without evaluating the home recordings.
Drug: Desmopressin
Children will receive conditional alarm without evaluating the home recordings.
Device: Conditional alarm
Children with polyuria based on the home recordings will receive desmopressin.
Drug: Desmopressin
Children with reduced bladder capacity based on the home recordings will receive the conditional alarm.
Device: Conditional alarm
Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm.
Drug: Desmopressin · Device: Conditional alarm
Children with neither nocturnal polyuria nor reduced bladder capacity based on the home recordings will be randomized to either desmopressin or alarm treatment. If there is no effect of the treatment, the treatment can be switched.
Drug: Desmopressin · Device: Conditional alarm
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).
Also known as: Minirin, melt
Eight weeks of treatment.
The number of children who responded to the treatment
Evaluated by home recordings
Time frame: Eight weeks
The number of children achieving complete dryness (complete responders)
Evaluated by home recordings
Time frame: Eight weeks
Change in wet nights
Evaluated by home recordings
Time frame: Eight weeks
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University of Aarhus