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| Name | Class |
|---|---|
| University Ghent | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| University Clinical Centre in Gdansk, Poland | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment without evaluating the home recordings, medicin. | Experimental | Children will receive desmopressin without evaluating the home recordings. |
|
| Treatment without evaluating the home recordings, alarm. | Experimental | Children will receive conditional alarm without evaluating the home recordings. |
|
| Treatment based on home recordings, polyuria. | Active Comparator | Children with polyuria based on the home recordings will receive desmopressin. |
|
| Treatment based on home recordings, reduced bladder capacity. | Active Comparator | Children with reduced bladder capacity based on the home recordings will receive the conditional alarm. |
|
| Treatment based on home recordings, both. | Active Comparator | Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The number of children who responded to the treatment | Evaluated by home recordings | Eight weeks |
| The number of children achieving complete dryness (complete responders) | Evaluated by home recordings | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wet nights | Evaluated by home recordings | Eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis Sint-Jan Brugge | Bruges | 8000 | Belgium | |||
| Ghent University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40728007 | Derived | 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. | |
| 38950376 | Derived | 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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| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| D005615 | Freezing |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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Randomized, controlled study
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The children and the parents will not know, if there treatment is based on home recordings or not.
| Treatment based on home recordings, none. | Active Comparator | 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. |
|
|
| Conditional alarm | Device | Eight weeks of treatment. |
|
| Ghent |
| 9000 |
| Belgium |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Aalborg University Hospital | Aalborg | Jylland | 9000 | Denmark |
| Aarhus University Hospital | Aarhus | Jylland | 8200 | Denmark |
| University Clinical Centre in GdaĆsk | Gdansk | 80-952 | Poland |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D044367 | Phase Transition |
| D055585 | Physical Phenomena |
| D003080 | Cold Temperature |
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055598 | Chemical Phenomena |