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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05759767

Enrollment

120

Registered

2023-03-08

Start date

2021-02-01

Completion date

2023-12-01

Last updated

2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Extracorporeal Shock Wave Lithotripsy, tamsulosin

Brief summary

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

Interventions

DRUGTamsulosin

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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026