New Treatment for Nocturnal Enuresis in Children

Sohag University

Status: Enrolling

Conditions: Nocturnal Enuresis in Children

Treatments: Drug: Imipramine; Drug: Sulbutiamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06497647

Soh-Med-24-06-05MS

Details and patient eligibility

About

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).

Enrollment: 450 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 3 patient groups

group A

Active Comparator group

Description:

this group will receive imipramine alone

Treatment:

Drug: Imipramine

group B

Active Comparator group

Description:

this group will receive sulbutiamine alone

Treatment:

Drug: Sulbutiamine

group C

Active Comparator group

Description:

this group will receive sulbutiamine plus imipramine

Treatment:

Drug: Sulbutiamine

Drug: Imipramine