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

Pediatric Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05896345
• Other study ID #: Paediatrics RLS
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Pediatric Kidney Disease

Intervention

Device:
• SWL
Shockwave Lithotripsy (SWL) For Paediatrics Radiolucent Renal Stone

Combination Product:
• SWL and ODT
Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Outside U.S./Canada

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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