Clinical trial

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

Name

DRYCHILD

Description

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.

Trial arms

Trial start

2017-10-01

Estimated PCD

2023-01-03

Trial end

2023-01-03

Status

Completed

Phase

Early phase I

Treatment

Desmopressin

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).

Arms:

Treatment based on home recordings, both., Treatment based on home recordings, none., Treatment based on home recordings, polyuria., Treatment without evaluating the home recordings, medicin.

Other names:

Minirin, melt

Conditional alarm

Eight weeks of treatment.

Arms:

Treatment based on home recordings, both., Treatment based on home recordings, none., Treatment based on home recordings, reduced bladder capacity., Treatment without evaluating the home recordings, alarm.

Size

324

Primary endpoint

The number of children who responded to the treatment

Eight weeks

The number of children achieving complete dryness (complete responders)

Eight weeks

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The children and the parents will not know, if there treatment is based on home recordings or not.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 324, 'type': 'ACTUAL'}}

Updated at

2023-08-02

1 organization

1 drug

2 indications

Organization

Drug

Indication

Indication