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NCT Number: NCT06497647

New Treatment for Nocturnal Enuresis in Children

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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Key information

Conditions

Nocturnal Enuresis in Children

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag Faculty of Medecine

Sohag, Egypt

Location status: Recruiting

Location contact

loai mohammed abd alhamied, resident

CONTACT

[email protected]

01093873434

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. reduction in the number of wet nights .

    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.

    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 outcomes

  1. determine any side effects of the drugs used in the study

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

loai mohammed abd alhamied, resident

CONTACT

[email protected]

01093873434

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Outcome of Treatment of Monosymptomatic Nocturnal Enuresis in Children Using Imipramine Alone Versus Sulbutiamine Alone Versus Imipramine Plus Sulbutiamine : Prospective Comparative Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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