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

Not Applicable

Active, not recruiting

• Conditions: Nocturnal Enuresis; Enuresis; Enuresis, Nocturnal
• Interventions: Drug: Fluoxetine 20 MG; Drug: Desmopressin

• Registration Number: NCT06185361
• Lead Sponsor: Fayoum University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-29
• Last Update Posted: 2023-12-29
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fluoxetine	Fluoxetine 20 MG	selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks
desmopressin	Desmopressin	0.2 mg desmopressin tablet for 12 weeks

Primary Outcome Measures

Name	Time	Method
The children will be non-responders, partial responders, or full responders to therapy	three months	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)

Trial Locations

Locations (1)

Faculty of medicine, Fayoum University; 🇪🇬 Fayoum, Egypt