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

Not Applicable

Active, not recruiting

• Conditions: Stone, Urinary; Tamsulosin; Extracorporeal Shock Wave Lithotripsy; Stone, Kidney; Pediatric Disorder
• Interventions: Drug: Placebo; Drug: Tamsulosin

• Registration Number: NCT05759767
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-08
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone
• Normal kidney function.

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Exclusion Criteria

• Bleeding diatheses
• Uncontrolled UTIs
• Severe skeletal malformations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Children in this group will receive Placebo for 3 weeks after ESWL session.
Tamsulosin	Tamsulosin	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.

Primary Outcome Measures

Name	Time	Method
assess the Stone-free rate (SFR) between groups	three months	SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Egypt