Nocturnal Enuresis Clinical Trial
Official title:
Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial
Verified date | December 2023 |
Source | Fayoum University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 16 Years |
Eligibility | Inclusion Criteria: 1. Age = 7 years 2. Severe enuresis with at least (50%) seven wet nights out of 14 3. Failed treatment 4. The enuresis alarm was either ineffective or considered impractical due to the family circumstances. Exclusion Criteria: 1. Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions 2. Patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder. 3. Untreated constipation 4. Contraindications to fluoxetine or desmopressin treatment |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of medicine, Fayoum University | Fayoum |
Lead Sponsor | Collaborator |
---|---|
Fayoum University Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The children will be non-responders, partial responders, or full responders to therapy | The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society "ICCS definitions" (i.e., if the reduction of enuresis frequency was below or above 50% or 90%, respectively) | three months |
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