Tamsulosin Treatment for Children with Posterior Urethral Valve A Phase 3 Randomized Study Evaluating Safety and Effectiveness

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the drug Tamsulosin, a selective alpha-1 adrenergic blocker, in children diagnosed with Posterior Urethral Valve PUV after valve ablation. It focuses on understanding how Tamsulosin affects the upper urinary tract, bladder outlet resistance, intravesical detrusor pressure, and the recurrence of febrile urinary tract infections in this population. Participants will be divided into two groups. One group will receive maintenance therapy with anticholinergic medication Oxybutynin and continuous antibiotic prophylaxis Trimethoprimsulfamethoxazole. The other group will receive the same maintenance therapy plus Tamsulosin, dosed orally once daily at 0.1 mg for children under 2 years and 0.2 mg for children 2 years and older. Both groups will be monitored and compared over a one-year period. Throughout the study, children will undergo evaluations to monitor their upper and lower urinary tract health, including assessments of hydronephrosis improvement, vesicoureteric reflux resolution, renal function, bladder outlet resistance, and detrusor pressure. Researchers will also track the recurrence of febrile urinary tract infections and observe any side effects related to Tamsulosin. The study will last for one year with continuous safety monitoring to assess the drugs impact.

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