New Treatment for Nocturnal Enuresis in Children
ConditionNocturnal Enuresis in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorSohag University
About this trial
The aim of the study is to evaluate the role of sulbutiamine in treatment of monosymptomatic nocturnal enuresis in children by using it alone or as a combination therapy with tricyclic antidepressants (imipramine+sulbutiamine).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age : 6 - 18 years old.
All children diagnosed by Primary monosymptomatic nocturnal enuresis in this age group.
Disqualifiers
Secondary nocturnal enuresis (child who has been continent for at least 6 months before the onset of bedwetting ).
congenital anomalies (Posterior urethral valve , ectopic ureter , ectopia vesica ,…)
history of previous lower urinary tract surgery (Multiple hypospadias surgeries ,…, )
neurogenic bladder (as underactive bladder ).and urge incontinence.
Trial design
Design model
Parallel
Treatments tested in this trial
Sulbutiamine
Drugsulbutiamine will be used by oral route 100 mg daily for 1 month and follow up will be done every 1 month till 3 months. it will be used alone in group B and combined with imipramine in group C
Imipramine
Drugimipramine will be used by oral route 25 mg daily for 1 month and follow up will be done every 1 month till 3 months. it will be used alone in group A and combined with sulbutiamine in group C
Treatment groups
450 Participants
are divided into 3 treatment groupsGroup A: group AActive comparator 1 intervention
Group B: group BActive comparator 1 intervention
Group C: group CActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
reduction in the number of wet nights .
A questionnaire which measure the Response to treatment which will be evaluated by the standardization committee of International clildren's continence society (ICCS) as follows : * Complete response : 100% reduction * Partial response : 50% - 99% reduction * Unresponsiveness : 0 - 49% reduction in nocturnal enuresis episodes. this will be measured by a questionnaire that will be written according a calendar fulfilled by the child and his parents with comparison of the number of wet nights each month.
Time frame
the number of wet nights will be measured and compared at the end of each month for 3 months using a calendar fulfilled by the child and his parents.Secondary outcomes
1
determine any side effects of the drugs used in the study
asking the child and his parents about any abnormal findings or symptoms appear in the period of the treatment this will be done by a questionnaire that will be fulfilled by the child and his parents.
Time frame
this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months.Sponsors and contacts
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Source ClinicalTrials.gov