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

Phase 4

Completed

• Conditions: Enuresis, Nocturnal
• Interventions: Device: Conditional alarm; Drug: Desmopressin

• Registration Number: NCT03389412
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2018-01-03
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment based on home recordings, reduced bladder capacity.	Conditional alarm	Children with reduced bladder capacity based on the home recordings will receive the conditional alarm.
Treatment without evaluating the home recordings, alarm.	Conditional alarm	Children will receive conditional alarm without evaluating the home recordings.
Treatment based on home recordings, none.	Conditional alarm	Children with neither nocturnal polyuria nor reduced bladder capacity based on the home recordings will be randomized to either desmopressin or alarm treatment. If there is no effect of the treatment, the treatment can be switched.
Treatment based on home recordings, both.	Conditional alarm	Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm.
Treatment without evaluating the home recordings, medicin.	Desmopressin	Children will receive desmopressin without evaluating the home recordings.
Treatment based on home recordings, polyuria.	Desmopressin	Children with polyuria based on the home recordings will receive desmopressin.
Treatment based on home recordings, both.	Desmopressin	Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm.
Treatment based on home recordings, none.	Desmopressin	Children with neither nocturnal polyuria nor reduced bladder capacity based on the home recordings will be randomized to either desmopressin or alarm treatment. If there is no effect of the treatment, the treatment can be switched.

Primary Outcome Measures

Name	Time	Method
The number of children achieving complete dryness (complete responders)	Eight weeks	Evaluated by home recordings
The number of children who responded to the treatment	Eight weeks	Evaluated by home recordings

Secondary Outcome Measures

Name	Time	Method
Change in wet nights	Eight weeks	Evaluated by home recordings

Trial Locations

Locations (6)

Aalborg University Hospital; 🇩🇰 Aalborg, Jylland, Denmark

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Ghent University Hospital; 🇧🇪 Ghent, Belgium

Algemeen Ziekenhuis Sint-Jan Brugge; 🇧🇪 Brugge, Belgium

University Clinical Centre in Gdańsk; 🇵🇱 Gdańsk, Poland

Aarhus University Hospital; 🇩🇰 Aarhus, Jylland, Denmark