The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.

Enuresis, Nocturnal Clinical Trial

— DRYCHILD  

Official title:

The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389412
• Other study ID #: DRYCHILD
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: January 3, 2023

Study information

• Verified date: July 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Enuresis, Nocturnal
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

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).

Device:
• Conditional alarm
Eight weeks of treatment.

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Sint-Jan Brugge	Brugge
Belgium	Ghent University Hospital	Ghent
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
Denmark	Aalborg University Hospital	Aalborg	Jylland
Denmark	Aarhus University Hospital	Aarhus	Jylland
Poland	University Clinical Centre in Gdansk	Gdansk

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	First Affiliated Hospital of Zhengzhou University, China, University Clinical Centre in Gdansk, Poland, University Ghent

Countries where clinical trial is conducted

Belgium,  China,  Denmark,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of children who responded to the treatment	Evaluated by home recordings	Eight weeks
Primary	The number of children achieving complete dryness (complete responders)	Evaluated by home recordings	Eight weeks
Secondary	Change in wet nights	Evaluated by home recordings	Eight weeks