Status:
UNKNOWN
The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children
Lead Sponsor:
Mansoura University
Conditions:
Nocturnal Enuresis
Eligibility:
All Genders
8-18 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
- Depression
- Severe psychiatric diseases
- Untreated constipation
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04676139
Start Date
July 1 2020
End Date
December 1 2022
Last Update
December 19 2020
Active Locations (1)
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1
Mansoura urology and nephrology center
Al Mansurah, Dakahlia Governorate, Egypt, 0502263717