Enuresis, NocturnalPhase 4DRYCHILDNCT03389412
The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.
A Phase 4 study testing Desmopressin and Conditional alarm in people with Enuresis, Nocturnal, run by University of Aarhus at 6 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Enuresis, Nocturnal
- What is being tested?
- Desmopressin and Conditional alarm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Oct 2017to 3 Jan 2023
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-14 years.
- Three or more wet nights per week regarding the home registrations.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Belgium2 sites
Algemeen Ziekenhuis Sint-Jan Brugge
Bruges, 8000
Ghent University Hospital
Ghent, 9000
Denmark2 sites
Aalborg University Hospital
Aalborg, Jylland, 9000
Aarhus University Hospital
Aarhus, Jylland, 8200
About this study
Official title: The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.
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.
Read the 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.
- Conditions
- Enuresis, Nocturnal
- Being tested
- Desmopressin, Conditional alarm
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Minirin, melt
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).
Conditional alarmDevice
Eight weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment without evaluating the home recordings, medicin. | Experimental | Children will receive desmopressin without evaluating the home recordings. Receives: Drug: Desmopressin |
| Treatment without evaluating the home recordings, alarm. | Experimental | Children will receive conditional alarm without evaluating the home recordings. Receives: Device: Conditional alarm |
| Treatment based on home recordings, polyuria. | Active comparator | Children with polyuria based on the home recordings will receive desmopressin. Receives: Drug: 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. Receives: Device: 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. Receives: Drug: Desmopressin; Device: Conditional alarm |
| 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. Receives: Drug: Desmopressin; Device: Conditional alarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of children who responded to the treatment
Evaluated by home recordings
Measured: Eight weeks
The number of children achieving complete dryness (complete responders)
Evaluated by home recordings
Measured: Eight weeks
Secondary outcomes (1)
Change in wet nights
Evaluated by home recordings
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Oct 2017
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
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 Enuresis, NocturnalStudies 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
- Parallel groups
- Model description
- Randomized, controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, The First Affiliated Hospital of Zhengzhou University, University Clinical Centre in Gdansk, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389412
- Sponsor's protocol ID
- DRYCHILD
- Acronym
- DRYCHILD
- Status last verified
- Jul 2023
- First submitted
- 27 Dec 2017
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 40728007Jorgensen 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.
PubMed 38950376
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.
- ClinicalTrials.gov ID
- NCT03389412
- Acronym / sponsor ID
- DRYCHILD / DRYCHILD
- Conditions
- Enuresis, Nocturnal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University Ghent, The First Affiliated Hospital of Zhengzhou University, University Clinical Centre in Gdansk, Poland
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 3 Jan 2018 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Treatment without evaluating the home recordings, medicin. | Experimental | Drug: DesmopressinChildren will receive desmopressin without evaluating the home recordings. |
| Treatment without evaluating the home recordings, alarm. | Experimental | Device: Conditional alarmChildren will receive conditional alarm without evaluating the home recordings. |
| Treatment based on home recordings, polyuria. | Active comparator | Drug: DesmopressinChildren with polyuria based on the home recordings will receive desmopressin. |
| Treatment based on home recordings, reduced bladder capacity. | Active comparator | Device: Conditional alarmChildren with reduced bladder capacity based on the home recordings will receive the conditional alarm. |
| Treatment based on home recordings, both. | Active comparator | Drug: Desmopressin, Device: Conditional alarmChildren with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm. |
| Treatment based on home recordings, none. | Active comparator | Drug: Desmopressin, Device: Conditional alarmChildren 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. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6-14 years.
- Three or more wet nights per week regarding the home registrations.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| DesmopressinAlso: Minirin, meltThe 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). | Drug | Treatment based on home recordings, both., Treatment based on home recordings, none., Treatment based on home recordings, polyuria., Treatment without evaluating the home recordings, medicin. |
| Conditional alarmEight weeks of treatment. | Device | Treatment based on home recordings, both., Treatment based on home recordings, none., Treatment based on home recordings, reduced bladder capacity., Treatment without evaluating the home recordings, alarm. |
Primary outcome
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
1 secondary outcome
Change in wet nights
Time frame: Eight 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 2 Aug 2023.
- 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 38950376Jorgensen 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.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desmopressin and Conditional alarm in people with Enuresis, Nocturnal, run by University of Aarhus at 6 sites in 4 countries.
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 2 inclusion and 11 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Denmark, China, Poland. 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?
The number of children who responded to the treatment (time frame: Eight weeks). The study lists 2 primary outcomes in all. 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 NCT03389412, 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 2 Aug 2023.