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

NCT06737016 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

  • Posterior Urethral Valve

Interventions

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ashraf Tarek Hafez · Urology and Nephrology center,Mansoura university

  • Tamer Helmy · Urology and Nephrology center,Mansoura university

  • Ahmed Elkashef · Urology and Nephrology center,Mansoura university

  • Mohamed Hussiny · Urology and Nephrology center,Mansoura university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-05-31
Completion
2026-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06737016 on ClinicalTrials.gov