New treatment for bedwetting in children
Outcome of Treatment of Monosymptomatic Nocturnal Enuresis in Children Using Imipramine Alone Versus Sulbutiamine Alone Versus Imipramine Plus Sulbutiamine : Prospective Comparative Study
NA · Sohag University · NCT06497647
This study tests if a new treatment using sulbutiamine, alone or with another medicine, can help children aged 6 to 18 who wet the bed at night.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Sohag University (other) |
| Locations | 1 site (Sohag) |
| Trial ID | NCT06497647 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of sulbutiamine, both alone and in combination with imipramine, for treating monosymptomatic nocturnal enuresis in children aged 6 to 18 years. The trial aims to determine if this treatment can improve bedwetting outcomes compared to standard therapies. Participants will be closely monitored for changes in their condition throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 18 years diagnosed with primary monosymptomatic nocturnal enuresis.
Not a fit: Patients with secondary nocturnal enuresis or those with specific medical conditions affecting bladder function will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce or eliminate bedwetting episodes in affected children, improving their quality of life.
How similar studies have performed: While there have been various treatments for nocturnal enuresis, the specific combination of sulbutiamine and imipramine is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sohag
- Sohag Faculty of Medecine — Sohag, Egypt (RECRUITING)
Study contacts
- Study coordinator: loai mohammed abd alhamied, resident
- Email: loaimohamed519@yahoo.com
- Phone: 01093873434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nocturnal Enuresis in Children, treatment of monosymptomatic nocturnal enuresis in children using sulbutiamine