Clinical trial NCT03389412: The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.
Official title: The Effect of Clinical Characterization of Children With Monosymptomatic Nocturnal Enuresis on the Efficacy of Desmopressin and Alarm Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Enuresis, Nocturnal
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University Ghent
name: First Affiliated Hospital of Zhengzhou University, China
name: University Clinical Centre in Gdansk, Poland
First posted: 2018-01-03
Enrollment: 324
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of children who responded to the treatment
timeFrame: Eight weeks
measure: The number of children achieving complete dryness (complete responders)
timeFrame: Eight weeks
Secondary outcomes:
measure: Change in wet nights
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan Brugge
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Jylland
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Jylland
city: Gdańsk
country: Poland
facility: University Clinical Centre in Gdańsk
Study officials:
References: