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NCT05759767 Clinical Trial

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

Pediatric Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05759767
Other study ID # Ped MET SWL
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date December 1, 2023

Study information
Verified date February 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 120
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 three months
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