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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Active Comparator | this group will receive imipramine alone |
|
| group B | Active Comparator | this group will receive sulbutiamine alone |
|
| group C | Active Comparator | this group will receive sulbutiamine plus imipramine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulbutiamine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| loai mohammed abd alhamied, resident | Contact | 01093873434 | loaimohamed519@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag Faculty of Medecine | Recruiting | Sohag | Egypt |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 8, 2026 | |
| Reset | Feb 25, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 8, 2026 | Feb 25, 2026 |
| ID | Term |
|---|---|
| C031331 | sulbutiamine |
| D007099 | Imipramine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Imipramine | Drug | 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 |
|