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

NCT ID: NCT05759767

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-12-01

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology and Nephrology Center

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ped MET SWL

Identifier Type: -

Identifier Source: org_study_id

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