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Completed

NCT Number: NCT03389412

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

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.

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Key information

Conditions

Enuresis, Nocturnal Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mental Disorders Nocturnal Enuresis Urination Disorders Urogenital Diseases Urologic Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Algemeen Ziekenhuis Sint-Jan Brugge, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Minirin, melt

Conditional alarm

Device

Eight weeks of treatment.

Primary outcomes

  1. The number of children who responded to the treatment

    Time frame: Eight weeks

    Evaluated by home recordings

  2. The number of children achieving complete dryness (complete responders)

    Time frame: Eight weeks

    Evaluated by home recordings

Secondary outcomes

  1. Change in wet nights

    Time frame: Eight weeks

    Evaluated by home recordings

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The First Affiliated Hospital of Zhengzhou University
  • University Clinical Centre in Gdansk, Poland
  • University Ghent

Registry information

Official study title

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

Acronym: DRYCHILD

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2018
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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