Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone. A Randomised Controlled Trial

To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.

Study Overview

• Status: Completed
• Conditions: Pediatric Kidney Disease
• Intervention / Treatment: Device: SWL; Combination product: SWL and ODT

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Outside U.S./Canada
    • Mansoura, Outside U.S./Canada, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1-2.5 cm renal stone
• Normal Serum creatinine
• Radiolucent stone with Hounsfield units less than 400

Exclusion Criteria:

• Bleeding diatheses.
• Patients with a pacemaker.
• uncontrolled UTIs.
• Severe skeletal malformations.
• Arterial aneurysm in the vicinity of the stone.
• Anatomical obstruction distal to the stone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SWL; Shockwave Lithotripsy (SWL)	Device: SWL; Shockwave Lithotripsy (SWL) For Paediatrics Radiolucent Renal Stone
Active Comparator: SWL and ODT; Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)	Combination product: SWL and ODT; Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the stone free rate measured by computed tomograghy as asymptomatic insignificant residual fragments less than 3 mm	percentage of patient who are stone free	3 month

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: Paediatrics RLS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No