Nocturnal Enuresis in Children
Conditions
Keywords
treatment of monosymptomatic nocturnal enuresis in children using sulbutiamine
Brief summary
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).
Interventions
DRUGSulbutiamine
sulbutiamine 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
DRUGImipramine
imipramine 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
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Age : 6 - 18 years old. * All children diagnosed by Primary monosymptomatic nocturnal enuresis in this age group.
Exclusion criteria
* 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. * presence of post-void residual urine greater than 20% of functional bladder capacity. * history or evidence of disorders in other organs such as (cardiovascular system disease), liver , psychological problems , evident allergic reaction to both medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction in the number of wet nights . | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| determine any side effects of the drugs used in the study | this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months. | 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. |
Countries
Egypt
Contacts
Primary Contactloai mohammed abd alhamied, resident
Outcome results
None listed