Nocturnal Enuresis in ChildrenNCT06497647
New Treatment for Nocturnal Enuresis in Children
A study testing Sulbutiamine and Imipramine in people with Nocturnal Enuresis in Children, run by Sohag University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Enuresis in Children
- What is being tested?
- Sulbutiamine and Imipramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age : 6 - 18 years old.
- All children diagnosed by Primary monosymptomatic nocturnal enuresis in this age group.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medecine
Sohag
loai mohammed abd alhamied, resident, 01093873434, loaimohamed519@yahoo.com
About this study
Official title: 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).
- Conditions
- Nocturnal Enuresis in Children
- Being tested
- Sulbutiamine, Imipramine
- Keywords
- treatment of monosymptomatic nocturnal enuresis in children using sulbutiamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulbutiamineDrug
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
ImipramineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | this group will receive imipramine alone Receives: Drug: Imipramine |
| group B | Active comparator | this group will receive sulbutiamine alone Receives: Drug: Sulbutiamine |
| group C | Active comparator | this group will receive sulbutiamine plus imipramine Receives: Drug: Sulbutiamine; Drug: Imipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 :
- 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.
Measured: 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 outcomes (1)
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.
Measured: this will be discussed in the follow up that will be done in each month in the outpatient clinic for 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Mar 2024
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal Enuresis in ChildrenStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loai Mohammed Abd Al-Hamied, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497647
- Sponsor's protocol ID
- Soh-Med-24-06-05MS
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Treatment of Monosymptomatic Nocturnal Enuresis in Children Using Imipramine Alone Versus Sulbutiamine Alone Versus Imipramine Plus Sulbutiamine : Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06497647
- Acronym / sponsor ID
- Soh-Med-24-06-05MS
- Conditions
- Nocturnal Enuresis in Children
- Keywords
- treatment of monosymptomatic nocturnal enuresis in children using sulbutiamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Imipraminethis group will receive imipramine alone |
| group B | Active comparator | Drug: Sulbutiaminethis group will receive sulbutiamine alone |
| group C | Active comparator | Drug: Sulbutiamine, Drug: Imipraminethis group will receive sulbutiamine plus imipramine |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age : 6 - 18 years old.
- All children diagnosed by Primary monosymptomatic nocturnal enuresis in this age group.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulbutiaminesulbutiamine 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 | Drug | group B, group C |
| Imipramineimipramine 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 | group A, group C |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulbutiamine and Imipramine in people with Nocturnal Enuresis in Children, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact loai mohammed abd alhamied, resident (01093873434, loaimohamed519@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.