Actively Recruiting
Outcome of Treatment of Monosymptomatic Nocturnal Enuresis in Children Using Imipramine Alone Versus Sulbutiamine Alone Versus Imipramine Plus Sulbutiamine: Prospective Comparative Study
Led by Sohag University · Updated on 2024-07-12
450
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the role of sulbutiamine in treating monosymptomatic nocturnal enuresis in children aged 6 to 18 years. The study compares the effects of sulbutiamine alone, imipramine alone, and a combination of both drugs to understand their impact on reducing the number of wet nights in affected children. Participants are randomly assigned to one of three groups: one receiving 25 mg of imipramine daily, another receiving 100 mg of sulbutiamine daily, and a third group receiving both medications combined. Each treatment is taken orally for one month, with follow-up visits occurring monthly for a total of three months to monitor progress and side effects. During the study, children and their parents will record the number of wet nights each month using a calendar. Researchers will assess this data alongside any side effects reported during outpatient follow-ups. The primary measurement is the reduction in wet nights over three months, while safety is evaluated through monthly clinic visits. Participants can expect regular monitoring and support throughout the study period.
CONDITIONS
Brief Title
New Treatment for Nocturnal Enuresis in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age: 6 to 18 years old
- Diagnosis of primary monosymptomatic nocturnal enuresis in this age group
You will not qualify if you...
- Secondary nocturnal enuresis (child continent for at least 6 months before bedwetting started)
- Congenital urinary tract anomalies such as posterior urethral valve, ectopic ureter, or ectopia vesica
- History of previous lower urinary tract surgery, including multiple hypospadias surgeries
- Neurogenic bladder conditions and urge incontinence
- Presence of post-void residual urine greater than 20% of functional bladder capacity
- History or evidence of other organ disorders such as cardiovascular disease, liver disease, psychological problems, or allergic reaction to the study medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 month
Participants receive daily oral medication with imipramine, sulbutiamine, or both for 1 month to reduce the number of wet nights.
1 baseline visit and 3 monthly follow-up visits (in-person)
Duration - 2 months
Participants are monitored monthly for 2 additional months to assess side effects and treatment outcomes.
Monthly visits for 2 months (in-person)
Trial Site Locations
Total: 1 location
1
Sohag Faculty of Medecine
Sohag, Egypt
Actively Recruiting
Research Team
L
loai mohammed abd alhamied, resident
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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