The effect of clinical characterization of children with bedwetting on the efficacy of therapy.

The effect of clinical characterization of children with monosymptomatic nocturnal enuresis on the efficacy of desmopressin and alarm therapy. - DRYCHILD

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002169-23-DK

Enrollment

400

Registered

2017-06-30

Start date

2017-09-06

Completion date

Unknown

Last updated

2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enuresis nocturna MedDRA version: 20.1 Level: LLT Classification code 10014930 Term: Enuresis (non-organic) System Organ Class: 100000004873

Interventions

Trade Name: Minirin Pharmaceutical Form: Tablet INN or Proposed INN: DESMOPRESSIN CAS Number: 16679-58-6 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 120-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 6-14 years. 2. Three or more wet nights per week regarding the home registrations. Are the trial subjects under 18? yes Number of subjects for this age range: 400 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Ongoing constipation and/or faecal incontinence. 2. Daytime symptoms such as urgency, frequency or incontinence. 3. Recurrent urinary tract infections. 4. Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated. 5. Neurological and/or known clinically significant anatomical abnormalities of the urinary tract. 6. Former operations in the urinary tract. 7. Prior or ongoing treatment with alarm, desmopressin or anticholinergics. 8. Ongoing medication that may interfere with the parameters tested. 9. Pregnant or lactating girl. 10. Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatraemia or SIADH. 11. Hypersensitivity / allergy to substances in the tablets.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis in order to improve treatment efficacy. Our hypothesis is that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with monosymptomatic nocturnal enuresis and subsequent treatment tailoring improves the response to first-line treatment approach (desmopressin and alarm treatment). ;Secondary Objective: By evaluating the home recordings regarding nocturnal urine production and maximal voided volumes, we wish to decide the prevalence of nocturnal polyuria in treatment naïve children with monosymptomatic nocturnal enuresis. Furthermore, we will evaluate the children’s well-being before and after treatment for MNE by using the WHO-5 Well-Being Index. Our hypothesis is that children’s well-being is increased after successful treatment for MNE.;Primary end point(s): The primary outcome is efficacy in terms of reduction in number of wet nights measured by the home recordings. According to The International Children's Continence Society (ICCS), non-response corresponds to a reduction in wet nights of <50%, partial response as a reduction of 50 to 99% and complete response as a reduction of 100 %. ;Timepoint(s) of evaluation of this end point: 01-03-2022 – 01-12-2022: o Complete the study according to the protocol. o Data management and analysis. o Reporting.	—

Measure

Time frame

Main Objective: The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis in order to improve treatment efficacy. Our hypothesis is that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with monosymptomatic nocturnal enuresis and subsequent treatment tailoring improves the response to first-line treatment approach (desmopressin and alarm treatment). ;Secondary Objective: By evaluating the home recordings regarding nocturnal urine production and maximal voided volumes, we wish to decide the prevalence of nocturnal polyuria in treatment naïve children with monosymptomatic nocturnal enuresis. Furthermore, we will evaluate the children’s well-being before and after treatment for MNE by using the WHO-5 Well-Being Index. Our hypothesis is that children’s well-being is increased after successful treatment for MNE.;Primary end point(s): The primary outcome is efficacy in terms of reduction in number of wet nights measured by the home recordings. According to The International Children's Continence Society (ICCS), non-response corresponds to a reduction in wet nights of <50%, partial response as a reduction of 50 to 99% and complete response as a reduction of 100 %. ;Timepoint(s) of evaluation of this end point: 01-03-2022 – 01-12-2022: o Complete the study according to the protocol. o Data management and analysis. o Reporting.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints will be: - nocturnal urine production and maximal voided volumes in daytime during treatment. - the well-being of the children before and after treatment. ;Timepoint(s) of evaluation of this end point: 01-03-2022 – 01-12-2022: o Complete the study according to the protocol. o Data management and analysis. o Reporting.	—

Countries

Belgium, Denmark, Poland

Contacts

Public ContactAarhus University Hospital

Aarhus University Hospital

cecisi@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026