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Completed

NCT Number: NCT07668232

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

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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Key information

Age range

3 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Qina University hospital, South Valley University Hospital

Qina, South Valley, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Oxybutynin

Primary outcomes

  1. Efficacy of Mirabegron and Oxybutynin on upper and lower urinary tract

    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 .

  2. Safety of Mirabegron usage after posterior urethral valve ablation by measuring arterial blood pressure

    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 )

  3. Safety of Mirabegron usage after posterior urethral valve ablation by measuring heart rate

    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).

Secondary outcomes

  1. Urinary tract infection Recurrency

    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.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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