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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    400
  • sponsor
    University of Aarhus
Updated on 19 August 2021

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.

Details
Condition Nocturnal Enuresis
Treatment Desmopressin, Conditional alarm
Clinical Study IdentifierNCT03389412
SponsorUniversity of Aarhus
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

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
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