New Treatment for Nocturnal Enuresis in Children (NCT06497647) | Clinical Trial Compass
RecruitingNot Applicable
New Treatment for Nocturnal Enuresis in Children
Egypt450 participantsStarted 2024-03-01
Plain-language 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).
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
reduction in the number of wet nights .
Timeframe: 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.