New Treatment for Nocturnal Enuresis in Children

Not Applicable

Recruiting

• Conditions: Nocturnal Enuresis in Children
• Interventions: Drug: Sulbutiamine; Drug: Imipramine

• Registration Number: NCT06497647
• Lead Sponsor: Sohag University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2024-09
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	Sulbutiamine	this group will receive sulbutiamine plus imipramine
group A	Imipramine	this group will receive imipramine alone
group B	Sulbutiamine	this group will receive sulbutiamine alone
group C	Imipramine	this group will receive sulbutiamine plus imipramine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sohag Faculty of Medecine; 🇪🇬 Sohag, Egypt