The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis

N/AUnknownNCT05759767

Mansoura University120 enrolled

Overview

The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Tamsulosin Extracorporeal Shock Wave Lithotripsy Stone, Kidney Stone, Urinary Pediatric Disorder

Interventions

TamsulosinDRUG

Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session.

PlaceboDRUG

Children in this group will receive placebo once daily for 3 weeks after ESWL session.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone * Normal kidney function. Exclusion Criteria: * Bleeding diatheses * Uncontrolled UTIs * Severe skeletal malformations

Locations (1)

Urology and Nephrology Center

Al Mansurah, Egypt

Outcomes

Primary Outcomes

assess the Stone-free rate (SFR) between groups

SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography

Time frame: three months

Data from ClinicalTrials.gov

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