NCT05759767

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.8 years

First QC Date

February 26, 2023

Last Update Submit

March 8, 2023

Conditions

TamsulosinExtracorporeal Shock Wave LithotripsyStone, KidneyStone, UrinaryPediatric Disorder

Keywords

Extracorporeal Shock Wave Lithotripsytamsulosin

Outcome Measures

Primary Outcomes (1)

  • 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

    three months

Study Arms (2)

Tamsulosin

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TamsulosinDRUG

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.

Tamsulosin
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone
  • Normal kidney function.

You may not qualify if:

  • Bleeding diatheses
  • Uncontrolled UTIs
  • Severe skeletal malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Kidney CalculiUrinary Calculi

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 8, 2023

Study Start

February 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 10, 2023

Record last verified: 2023-02

Locations

EG(1)