New Treatment for Nocturnal Enuresis in Children

July 11, 2024 updated by: Loai Mohammed Abd Al-Hamied, Sohag University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • sohag faculty of medecine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
this group will receive imipramine alone
Drug: Imipramine

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
Active Comparator: group B
this group will receive sulbutiamine alone
Drug: Sulbutiamine

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
Active Comparator: group C
this group will receive sulbutiamine plus imipramine
Drug: Imipramine

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

Drug: Sulbutiamine

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-06-05MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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