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

Study Overview
=================
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.

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

Conditions
-----------------
Enuresis, Nocturnal

Intervention / Treatment
-----------------
* Drug: Desmopressin
* Device: Conditional alarm


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment without evaluating the home recordings, medicin.<br>Children will receive desmopressin without evaluating the home recordings. | Drug: Desmopressin<br>* 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).<br>* Other names: Minirin, melt;|
| Experimental: Treatment without evaluating the home recordings, alarm.<br>Children will receive conditional alarm without evaluating the home recordings. | Device: Conditional alarm<br>* Eight weeks of treatment.<br>|
| Active Comparator: Treatment based on home recordings, polyuria.<br>Children with polyuria based on the home recordings will receive desmopressin. | Drug: Desmopressin<br>* 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).<br>* Other names: Minirin, melt;|
| Active Comparator: Treatment based on home recordings, reduced bladder capacity.<br>Children with reduced bladder capacity based on the home recordings will receive the conditional alarm. | Device: Conditional alarm<br>* Eight weeks of treatment.<br>|
| Active Comparator: Treatment based on home recordings, both.<br>Children with polyuria and reduced bladder capacity based on the home recordings will receive desmopressin and the conditional alarm. | Drug: Desmopressin<br>* 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).<br>* Other names: Minirin, melt;Device: Conditional alarm<br>* Eight weeks of treatment.<br>|
| Active Comparator: Treatment based on home recordings, none.<br>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. | Drug: Desmopressin<br>* 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).<br>* Other names: Minirin, melt;Device: Conditional alarm<br>* Eight weeks of treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of children who responded to the treatment | Evaluated by home recordings | Eight weeks | 
| The number of children achieving complete dryness (complete responders) | Evaluated by home recordings | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wet nights | Evaluated by home recordings | Eight weeks |