Clinical trial

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

NCT05759767

Name

Ped MET SWL

Description

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

Trial arms

Trial start

2021-02-01

Estimated PCD

2023-12-01

Trial end

2023-12-01

Status

Active (not recruiting)

Treatment

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.

Arms:

Tamsulosin

Placebo

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

Arms:

Placebo

Size

120

Primary endpoint

assess the Stone-free rate (SFR) between groups

three months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2023-03-10

1 organization

1 product

1 drug

6 indications

Organization

Mansoura University

Product

Tamsulosin

Indication

Tamsulosin