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

Fayoum University Hospital

Status: Active, not recruiting

Conditions: Enuresis, Nocturnal; Enuresis; Nocturnal Enuresis

Treatments: Drug: Fluoxetine 20 MG; Drug: Desmopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT06185361

Nocturnal Enuresis

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

fluoxetine

Active Comparator group

Description:

selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks

Treatment:

Drug: Fluoxetine 20 MG

desmopressin

Active Comparator group

Description:

0.2 mg desmopressin tablet for 12 weeks

Treatment:

Drug: Desmopressin