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

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Enuresis, Nocturnal

Treatments: Drug: Desmopressin; Device: Conditional alarm

Study type: Interventional

Funder types: Other

Identifiers

NCT03389412

DRYCHILD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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324 participants in 6 patient groups

Treatment without evaluating the home recordings, medicin.

Experimental group

Description:

Children will receive desmopressin without evaluating the home recordings.

Treatment:

Drug: Desmopressin

Treatment without evaluating the home recordings, alarm.

Experimental group

Description:

Children will receive conditional alarm without evaluating the home recordings.

Treatment:

Device: Conditional alarm

Treatment based on home recordings, polyuria.

Active Comparator group

Description:

Children with polyuria based on the home recordings will receive desmopressin.

Treatment:

Drug: Desmopressin

Treatment based on home recordings, reduced bladder capacity.

Active Comparator group

Description:

Children with reduced bladder capacity based on the home recordings will receive the conditional alarm.

Treatment:

Device: Conditional alarm

Treatment based on home recordings, both.

Active Comparator group

Description:

Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm.

Treatment:

Device: Conditional alarm

Drug: Desmopressin

Treatment based on home recordings, none.

Active Comparator group

Description:

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:

Device: Conditional alarm

Drug: Desmopressin