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

Sponsor

Mansoura University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05759767

Collaborator

(none)

120

Enrollment

Location

Arms

33.9

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tamsulosin Extracorporeal Shock Wave Lithotripsy Stone, Kidney Stone, Urinary Pediatric Disorder	Drug: Tamsulosin Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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 Comparator: Placebo Children in this group will receive Placebo for 3 weeks after ESWL session.	Drug: Placebo Children in this group will receive placebo once daily for 3 weeks after ESWL session.

Arm

Intervention/Treatment

Active Comparator: 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.

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 Comparator: Placebo

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

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

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