The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children

Phase 3

• Conditions: Nocturnal Enuresis
• Interventions: Drug: Fluoxetine; Drug: Placebo

• Registration Number: NCT04676139
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-05
• Study First Submitted QC: 2020-12-15
• Last Update Submitted: 2020-12-15
• Study First Posted: 2020-12-19
• Last Update Posted: 2020-12-19
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoxetine	Fluoxetine	patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks
Placebo	Placebo	patients will undergo maintenance therapy Placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.	6 months	counting the wet nights numbers between baseline and after 2 weeks of each treatment period

Secondary Outcome Measures

Name	Time	Method
assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.	6 months	by counting the numbers of complication of each drugs

Trial Locations

Locations (1)

Mansoura urology and nephrology center; 🇪🇬 Mansoura, Dakahlia, Egypt