Ultraslow SWL Versus Slow SWL for Renal Stones With High Attenuation Value

Not Applicable

• Conditions: Renal Stones

• Registration Number: NCT03795532
• Lead Sponsor: Cairo University

Brief Summary

Ultraslow full-power SWL versus slow power-ramping SWL in Renal stones with high attenuation value

Detailed Description

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL for renal stones

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-07
• Study Start: 2019-01-11
• Last Update Submitted: 2019-01-20
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-05
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• single Renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
• radio-opaque stone
• high attenuation value (≥ 1000 HU) stone

Exclusion Criteria

• Abnormal renal anatomy
• renal insufficiency
• solitary kidney
• coagulopathies
• uncontrolled hypertension
• renal artery or aortic aneurysm
• active urinary tract infection
• pregnancy
• severe skeletal malformations (spinal deformity) precluding proper stone localization
• skin to stone distance (SSD) > 11 cm
• BMI > 30 Kgm/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
stone free rate	3 months following last session of SWL	Complete clearance of stones in addition to clinically insignificant residual fragments

Secondary Outcome Measures

Name	Time	Method
Complications rate	3 months following last session of SWL	Comparison of rate of complications in both groups

Trial Locations

Locations (1)

Beni-Suef Hospitals; 🇪🇬 Banī Suwayf, Outside U.S./Canada, Egypt