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

Primary Purpose

Tamsulosin, Extracorporeal Shock Wave Lithotripsy, Stone, Kidney

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tamsulosin
Placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tamsulosin focused on measuring Extracorporeal Shock Wave Lithotripsy, tamsulosin

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tamsulosin

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

assess the Stone-free rate (SFR) between groups
SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography

Secondary Outcome Measures

Full Information

First Posted
February 26, 2023
Last Updated
March 8, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05759767
Brief Title
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
Official Title
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tamsulosin, Extracorporeal Shock Wave Lithotripsy, Stone, Kidney, Stone, Urinary, Pediatric Disorder
Keywords
Extracorporeal Shock Wave Lithotripsy, tamsulosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Children in this group will receive Placebo for 3 weeks after ESWL session.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Children in this group will receive placebo once daily for 3 weeks after ESWL session.
Primary Outcome Measure Information:
Title
assess the Stone-free rate (SFR) between groups
Description
SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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