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Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation

Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation: A Comparative Prospective Randomized Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07668232
Enrollment
52
Registered
2026-06-25
Start date
2025-01-01
Completion date
2025-12-30
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Urethral Valve

Brief summary

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.

Detailed description

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.

Interventions

DRUGMirabegron

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.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
3 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

\- All children older than 3 years old who have undergone posterior urethral valve ablation

Exclusion criteria

* Children younger than 3 years old. * Children with residual valve. * Children who had undergone urinary diversion (vesicostomy or ureterostomy). * Children with other conditions that can potentially affect upper or lower urinary tract function (spina bifida, anorectal malformation,prune belly syndrome).

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of Mirabegron and Oxybutynin on upper and lower urinary tract6 MonthsAssessment 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 .
Safety of Mirabegron usage after posterior urethral valve ablation by measuring arterial blood pressure6 MonthsAssessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring arterial blood pressure by Mercury Sphygmomanometer (mmHg )
Safety of Mirabegron usage after posterior urethral valve ablation by measuring heart rate6 MonthsAssessment of the safety of Mirabegron drug in children after posterior urethral valve ablation by measuring heart rate by pulse oximeter (beat per minute).

Secondary

MeasureTime frameDescription
Urinary tract infection Recurrency6 MonthsAssessment 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.

Countries

Egypt

Contacts

STUDY_CHAIRAhmad Abolyosr Mohamed, Professor

Professor of Urology, Faculty of medicine,South Valley University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026