What this Trial Is About

This research aims to evaluate the safety and effectiveness of tamsulosin, a selective alpha-1 adrenergic blocker, in treating children diagnosed with posterior urethral valves after valve ablation. The study focuses on how tamsulosin affects the upper urinary tract, bladder outlet resistance, intravesical detrusor pressure, and the recurrence of febrile urinary tract infections. This is a Phase 3 randomized controlled trial involving children up to 12 years old. Participants will receive oral tamsulosin daily, with doses adjusted by age: 0.1 mg once daily for children under 2 years old and 0.2 mg once daily for those aged 2 years or older. Additional treatments include oral oxybutynin at 0.2 mg/kg twice daily and prophylactic oral trimethoprim/sulfamethoxazole at 2 mg/kg once nightly. The trial compares these interventions to assess both efficacy and safety over a one-year period. During the study, children will be closely monitored for improvements in hydronephrosis, resolution of vesicoureteric reflux, renal function, bladder pressure, and urinary tract infection recurrence. Researchers will assess the effects of tamsulosin on the urinary system and track any side effects or safety concerns. The total participation time is one year, during which regular evaluations will help measure the drug's impact on urinary tract health.

Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.