The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Fluoxetine patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks |
Drug: Fluoxetine
Fluoxetine 10 mg capsules once daily for 12 months
|
Placebo Comparator: Placebo patients will undergo maintenance therapy Placebo for 12 weeks |
Drug: Placebo
placebo for 12 months
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mansoura urology and nephrology center | Mansoura | Dakahlia | Egypt | 0502263717 |
Sponsors and Collaborators
- Mansoura University
Investigators
- Study Chair: Mahmoud Elkenawy, Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university
- Study Director: Tamer El-sayed Helmy, Associate Professor of urology Urology and Nephrology center Faculty of medicine Mansoura university
- Study Director: Ahmed Abdelhalem, Lecturer of urology Urology and Nephrology center Faculty of medicine Mansoura university
- Principal Investigator: Mohamed Hussiny abdelazim, Resident in Urology Urology and Nephrology canter Mansoura University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SSRI & Nocturnal enuresis