Qina University hospital, South Valley University Hospital
Qina, South Valley, Egypt
NCT Number: NCT07668232
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.
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Notify Me3 year–12 year
Male
Interventional
Not applicable
Qina, South Valley, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Oxybutynin
Time frame: 6 Months
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 .
Time frame: 6 Months
Assessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring arterial blood pressure by Mercury Sphygmomanometer (mmHg )
Time frame: 6 Months
Assessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring heart rate by pulse oximeter (beat per minute).
Time frame: 6 Months
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.
South Valley University
Other
Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation: A Comparative Prospective Randomized Study
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