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

NCT07668232 | Completed DMC

• 1 other identifier: Mirabegron versus Oxybutynin
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Urethral Valve

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Urinary tract infection Recurrency

  6 Months

Study Arms (2)

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.

Drug: Mirabegron

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.

Drug: Mirabegron

Interventions

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.

Also known as: Oxybutynin

Group A (Mirabegron Tablets):; Group B (Oxybutynin Tablets):

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qina University hospital, South Valley University Hospital

Qina, South Valley, Egypt

Location

MeSH Terms

Interventions

mirabegron; oxybutynin

Study Officials

• Ahmad Abolyosr Mohamed, Professor

  Professor of Urology, Faculty of medicine,South Valley University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Lecture at Urology Department

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 25, 2026
• Study Start: January 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: June 29, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)