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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06185361
Enrollment
60
Registered
2023-12-29
Start date
2022-12-01
Completion date
2024-03-01
Last updated
2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturnal Enuresis, Enuresis, Enuresis, Nocturnal

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.

Interventions

fluoxetine

DRUGDesmopressin

desmopressin

Sponsors

Fayoum University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The children will be non-responders, partial responders, or full responders to therapythree monthsThe 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026