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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06185361
Other study ID # Nocturnal Enuresis
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date March 1, 2024

Study information

Verified date December 2023
Source Fayoum University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 8 Years to 16 Years
Eligibility 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

Study Design


Intervention

Drug:
Fluoxetine 20 MG
fluoxetine
Desmopressin
desmopressin

Locations

Country Name City State
Egypt Faculty of medicine, Fayoum University Fayoum

Sponsors (1)

Lead Sponsor Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The children will be non-responders, partial responders, or full responders to therapy The 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) three months
See also
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Enrolling by invitation NCT05710718 - PureWick™ France and U.S. At-Home Pilot Study N/A
Recruiting NCT06135311 - Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children N/A
Completed NCT03047720 - Scheduled Awakenings for the Treatment of Nocturnal Enuresis N/A
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Completed NCT02068560 - The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion N/A
Withdrawn NCT02337413 - Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis Phase 4
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Terminated NCT04420585 - Desmopressin for Bedwetting in Children With SCD Phase 4
Completed NCT02538302 - Minirin Versus Oxybutynin for Nocturnal Enuresis in Children Phase 3
Recruiting NCT04676139 - The Safety and Efficacy of Fluoxetine for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children Phase 3
Completed NCT03812094 - Basic Bladder Advice and Alarm Therapy in Nocturnal Enuresis N/A
Recruiting NCT03477812 - Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study
Completed NCT02178826 - Nocturnal Enuresis and Rapid Maxillary Expansion N/A
Recruiting NCT01575678 - The Effect of Melatonin on Nocturnal Enuresis Phase 2
Completed NCT01078753 - Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis Phase 3
Recruiting NCT04313192 - TENS Treatment for Bedwetting N/A