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Posterior urethral valve is the main cause of bladder outlet obstruction in male infants and the most common cause of obstructive uropathy leading to chronic renal failure and end-stage renal disease in children.The incidence of posterior urethral valve is approximately 1:7,000-8,000 live births.
Posterior urethral valve is the main cause of bladder outlet obstruction in male infants and the most common cause of obstructive uropathy leading to chronic renal failure and end-stage renal disease in children.The incidence of posterior urethral valve is approximately 1:7,000-8,000 live births.
Anatomically, it is a membrane starting at the verumontanum and attached distally in the posterior urethra in the male child, resulting in valve like obstruction to the urine outflow leading to harmful effects on the urinary bladder and the upper urinary tracts.
Initial management of children with posterior urethral valves is immediate bladder drainage followed by endoscopic posterior urethral valve ablation. However, despite the early relief of bladder outlet obstruction, remaining pathological changes in the urinary bladder can lead to significant bladder dysfunction which leads to impaired upper tract drainage; valve bladder syndrome.
Oxybutynin is primarily indicated for the treatment of overactive bladder syndrome. It is still the most widely prescribed drug for overactive bladder in the world. It has been demonstrated to be safe for administration in the paediatric neurogenic bladder population.
Mirabegron, a beta-3 adrenergic agonist has been used for the treatment of overactive bladder symptoms as an alternative to anticholinergics with minimal side effects. Few studies stated safety of mirabegron in pediatric population with overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Mirabegron Tablets): | Active Comparator | About 26 children suffering from Valve Bladder Syndrome after posterior urethral valve ablation and will be maintained on Mirabegron tablets (0.5-1 mg/kg/daily) orally. |
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| Group B (Oxybutynin Tablets): | Active Comparator | About 26 children suffering from Valve Bladder Syndrome after posterior urethral valve ablation and will be maintained on Oxybutynin Syrup (0.2 mg/kg 3 times per day) orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | To assess the efficacy and the safety of Mirabegron and Oxybutynin drugs after posterior urethral valve ablation regarding: the Effect on upper and lower urinary tract and Febrile UTI recurrence. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Mirabegron and Oxybutynin on upper and lower urinary tract | Assessment the drugs used on the upper and lower urinary tract after posterior urethral valve ablation in children by using shape,wall, reflux and diverticuli (SWRD) score from 0 to 7 where as 0 is better improvement but 7 is worsen improvement . | 6 Months |
| Safety of Mirabegron usage after posterior urethral valve ablation by measuring arterial blood pressure | Assessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring arterial blood pressure by Mercury Sphygmomanometer (mmHg ) | 6 Months |
| Safety of Mirabegron usage after posterior urethral valve ablation by measuring heart rate | Assessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring heart rate by pulse oximeter (beat per minute). | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary tract infection Recurrency | Assessment of Efficacy of Mirabegron and Oxybutynin on reduction of the rate of Urinary tract infection by assessment of presence of significant pyuria in urine analysis. | 6 Months |
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Inclusion Criteria:
- All children older than 3 years old who have undergone posterior urethral valve ablation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Abolyosr Mohamed, Professor | Professor of Urology, Faculty of medicine,South Valley University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qina University hospital, South Valley University Hospital | Qina | South Valley | Egypt |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| C005419 | oxybutynin |
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