NCT06737016

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

Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To determine whether there is a role for Tamsulosin, A Selective Alpha-1 Adrenergic Blocker, as therapy in children with Posterior Urethral Valve post valve ablation , and whether there are side effects involved.

Detailed description

We aim to evaluate the safety and efficacy of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves regarding: * Effect on upper urinary tract (Hydronephrosis improvement, Vesicoureteric Reflux resolution and renal function) * Effect on bladder outlet resistance * Effect on intravesical detrusor pressure * Febrile Urinary Tract Infection recurrence

Conditions

• Posterior Urethral Valve

Interventions

Type	Name	Description
DRUG	Tamsulosin	Children will be maintained on an oral dose of Tamsulosin 0.1 mg once daily (in children aged less than 2 years old) and 0.2 mg once daily (≥2 years old).
DRUG	Oxybutynin	Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.
DRUG	Trimethoprim/sulfamethoxazole (TMP/SMZ)	Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2024-12-17
• Last updated: 2024-12-20

Locations

1 site across 1 country: Egypt