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

Mansoura University

Status: Completed

Conditions: Pediatric Kidney Disease

Treatments: Combination Product: SWL and ODT; Device: SWL

Study type: Interventional

Funder types: Other

Identifiers

NCT05896345

Paediatrics RLS

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

SWL

Active Comparator group

Description:

Shockwave Lithotripsy (SWL)

Treatment:

Device: SWL

SWL and ODT

Active Comparator group

Description:

Shockwave Lithotripsy (SWL) and Oral Dissolution Therapy (ODT)

Treatment:

Combination Product: SWL and ODT