RecruitingPhase 3NCT06737016

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


Sponsor

Mansoura University

Enrollment

50 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMax Age: 12 Years

Inclusion Criteria1

  • Children with a diagnosis of PUV.

Exclusion Criteria5

  • Patients with other conditions that can potentially affect lower or upper urinary tract functions (e.g. spinal dysraphism, anorectal malformation and prune belly syndrome)
  • Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.
  • Patients who had primary treatment of PUV ablation at other hospitals.
  • Contraindications to α blocker treatment.
  • Patients who refuse to participate in the study

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Interventions

DRUGTamsulosin

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).

DRUGOxybutynin

Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.

DRUGTrimethoprim/sulfamethoxazole (TMP/SMZ)

Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.


Locations(1)

Mansoura Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, Egypt

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NCT06737016


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