The Safety and Efficacy of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial

Mansoura University1 site in 1 country100 target enrollmentJuly 1, 2020

ConditionsNocturnal Enuresis

InterventionsFluoxetine Placebo

DrugsFluoxetine Placebo

Overview

Phase: Phase 3
Intervention: Fluoxetine
Conditions: Nocturnal Enuresis
Sponsor: Mansoura University
Enrollment: 100
Locations: 1
Primary Endpoint: assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To determine whether there is a role for the selective serotonin reuptake inhibitors, fluoxetine, as therapy in the treatment of refractory primary monosymptomatic nocturnal enuresis in children , and whether there are side effects involved.

Registry

clinicaltrials.gov

Start Date

July 1, 2020

End Date

December 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mansoura University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Primary Monosymptomatic nocturnal enuresis
•Failed treatment with desmopressin.
•The enuresis alarm had either been tried without effect, or deemed unfeasible because of the family situation.
•All patients had either tried and failed combination therapy with anticholinergics or, because of contraindications, been unable to receive such therapy.
•Severe enuresis with at least seven wet nights out of 14

Exclusion Criteria

•Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
•Depression
•Severe psychiatric diseases
•Untreated constipation

Arms & Interventions

Fluoxetine

patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks

Intervention: Fluoxetine

Placebo

patients will undergo maintenance therapy Placebo for 12 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.

Time Frame: 6 months

counting the wet nights numbers between baseline and after 2 weeks of each treatment period

Secondary Outcomes

assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.(6 months)