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

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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