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

Not Applicable

Completed

• Conditions: Pediatric Kidney Disease
• Interventions: Device: SWL; Combination Product: SWL and ODT

• Registration Number: NCT05896345
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SWL	SWL	Shockwave Lithotripsy (SWL)
SWL and ODT	SWL and ODT	Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Outside U.S./Canada, Egypt