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

Mansoura University

Status: Active, not recruiting

Conditions: Stone, Kidney; Pediatric Disorder; Extracorporeal Shock Wave Lithotripsy; Stone, Urinary; Tamsulosin

Treatments: Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT05759767

Ped MET SWL

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Tamsulosin

Active Comparator group

Description:

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.

Treatment:

Drug: Tamsulosin

Placebo

Placebo Comparator group

Description:

Children in this group will receive Placebo for 3 weeks after ESWL session.

Treatment:

Drug: Placebo