Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value

Not Applicable

Completed

• Conditions: Renal Stones

• Registration Number: NCT03763539
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2017-05
• Study Completion: 2018-05
• Status Verified: 2018-12
• Study First Submitted: 2018-12-01
• Study First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Study First Posted: 2018-12-04
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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	1 year following last session of SWL	Comparison of complications in both groups

Trial Locations

Locations (1)

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