A Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

Study Overview
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Brief Summary
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To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment. To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment. To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

Detailed Description
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To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment. To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment. To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

Official Title
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An Open Label, Multi-national Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

Conditions
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Nocturnal Enuresis

Intervention / Treatment
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* Drug: Primary nocturnal enuresis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Children suffering from primary nocturnal enuresis with no organic pathology. Children of either sex, not below 5 and not above 15 years of age (not below 6 years in The Netherlands and France). Children with a minimum of 6 wet nights in 2 weeks. Exclusion criteria: Children who have previously been treated with desmopressin or other medications for nocturnal enuresis or enuresis alarms. Children receiving substances that are known or suspected to potentiate antidiuretic hormone, e.g. SSRI, tricyclic antidepressant drugs, chlorpromazine and carbamazepine. Diagnosed renal diabetes insipidus or central diabetes insipidus with an AVP (arginine vasopressin) deficiency. Proven urinary tract infection within the past month or a documented positive urine culture at the start of the study

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Primary nocturnal enuresis<br>* Desmopressin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment. |  |  | 
| To evaluate the proportion of patients achieving dryness. |  |  | 
| To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary nocturnal enuresis