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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06185361
• Other study ID #: Nocturnal Enuresis
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2023
• Source: Fayoum University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Enuresis
• Enuresis, Nocturnal
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Drug:
• Fluoxetine 20 MG
fluoxetine
• Desmopressin
desmopressin

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Fayoum University	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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