Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial

Nocturnal Enuresis

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.

2022-12-01

2024-03-01

2024-03-01

Active (not recruiting)

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-12-29